Update 12/20/22: For years, consumers have been able to get the brand Concerta sold as a generic — that is, an “authorized generic.” That has ended.
With the introduction since 2016 of about 20 cheap generics not using Alza’s OROS technology, access has been more limited but still accessible. No longer. Read more at Janssen Quietly Ends Authorized Generic
6/10/19: This post still explains details around what constitutes a generic, and you might scan the subheads to learn useful information. But with the introduction of at least four 12 who-the-heck-knows more Concerta generics, I have written a new post (since outdated given the news above): Authorized Generic Concerta Update.
The term authorized generic is used when the brand is sold as a generic, at generic prices.
Original story: 12/31/17
Three Concerta generics are slowly making their way into consumers’ hands. Already I’m hearing negative reports. This post provides a quick run-down. Please leave a comment if you have useful information.
The timing is bad. On December 31, 2017, the marketing deal expires between Concerta maker Janssen and generic pharma Actavis—the deal that brought us brand Concerta at generic prices (in other words, an authorized generic; more on this below).
Update 6/20/18: This spring, another company (Amneal) introduced a generic Concerta. The pace is dizzying. I will update info as much as I can in the link I provided above: Authorized Generic Concerta Update: Yet Another (6/1/19)
My first thought was, “Here we go again.” In 2014, ADHD Roller Coaster readers and others petitioned the FDA to downgrade the last round of generics for Concerta. We succeeded (see Victory! Concerta Generics Downgraded!). As a result, these inferior generics could no longer be substituted for brand.
In this post, you’ll find a comprehensive Q&A about the two different types of generic medications (authorized and true), why the FDA downgraded those Concerta generics, and more (updated 10/2016): Consumer Q&A on Concerta Generics
Now we face four new generics. None uses the novel OROS delivery technology from Alza that gives Concerta its unique release.
This threatens to send many children and adults with ADHD into a scramble, to either find the authorized generic or risk a trial of the four new generics.
Q&A on Concerta Generics
I’ll answer 10 common questions below.
1. Bottom line: What do Concerta users need to know?
Chiefly, you should know that not one of these three generics uses the patented OROS delivery system that is central to Concerta’s delivery system. (You’ll know it’s the same OROS technology if it says “Alza” on the pill.)
As a result, many people will find the generic doesn’t work as well as the brand. (Yes, some people might actually prefer the generic. But the point is not consumer preference; the point is that generics should have the same effect as the brand.)
If brand Concerta works well for you or your child, however, and you don’t want to risk going off the rails, you might want to stick with the brand, whether sold as brand or the authorized generic (brand marketed as a generic).
[advertising; not endorsement] [advertising; not endorsement]
Here is a post consisting of first-person stories detailing adverse reactions to the previous, now downgraded, Concerta generics: Sound Off: Users of Downgraded Concerta Generics
2. How many generics and who makes them?
There are four new generics for Concerta on the market within the last year:
- Trigen Laboratories
- Mylan (of Epi-Pen infamy)
- Impax Laboratories
- Amneal
1. Trigen
Reports so far are not good on the Trigen generic:
-
- One month of my son being on the Trigen generic made me want to lose my mind, and now we’ve had two glorious weeks back on the authorized generic. [NOTE: this is the brand sold as a generic.] This is so depressing.
- The first month of Trigen generic was no good! CVS insisted that it was equivalent and that’s all they stock now. So I had to switch to Walgreens this month since they still carry Actavis generic. [NOTE: this is the brand sold as a generic.) The time release mechanism [Alza’s OROS] is what it’s all about!
- I’m finding the Trigen generic is horrible.
UPDATE 3/27/2018 : Trigen recalled their 36 mg. generic Concerta because it was considered sub-potent (27 mg). Generics are allowed a 20% window up or down, compared to brand; 20% would be 28.8, and this generic was 1.8 mg short. It might not seem like much, but typically people with ADHD have a very narrow window of effective dosage; the 20 percent variability is risk enough. More about generics and “bioequivalence” below.
For more information, check this link to the FDA page:
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=162135
2. Mylan:
I received this e-mail from an ADHD specialist familiar to me (meaning, I trust her):
Dear Gina: This is a picture of my patient’s generic 18 mg Mylan generic for Concerta.
He agreed to let us look at pills and it is interesting that 8 of the remaining 18 pills left in the bottle have no obvious drill hole. Never saw that with Concerta tablets.
Is Mylan trying to pass off an inferior technology as very similar to the Alza OROS or does it have very lax quality control—or both? I’ve heard that the company explains that the outer coating, which apparently can dispense in uneven thickness, dissolves quickly, revealing the hole.
3. Impax
I’ve received no reports on the generic Concerta from Impax.
If you have already experienced negative effects from one of these generics, please consider filing a MedWatch complaint with the FDA.
That’s how we succeeded in downgrading the previous (inferior) Concerta generics. Skip to #10, below, for instructions.
Update 8/2021: I’m not optimistic on getting this clown car of Concerta generics downgraded. But what the heck. Maybe it will make you feel better.
3. But, I’ve gotten the Actavis Concerta generic for a while now. Will that stop?
Maybe. But if you do, it will be from Teva generics Patriot Pharmaceuticals now, not Actavis, until it’s not from Teva but another distributor.
First, neither Actavis nor Teva nor any other distributor manufactures this generic, which is not a generic per se. Instead, it is an “authorized generic.” That means it is the brand product marketed as a generic. (I know! I repeat this ad nauseum. But still, some readers remain confused.)
Years ago, Actavis agreed to delay launching its Concerta generic if Concerta manufacturer Janssen would cut a deal to let Actavis market the brand as a generic. That’s what “authorized generic” means. That deal expired 12/31/2017.
Sometime thereafter, generics manufacturer Teva purchased Actavis. Teva refused to share with me any information about any agreement with Janssen, including when it might expire. Very strange. Now I hear that Patriot Pharmaceuticals is also marketing the authorized generic.
Bottom line: Don’t specify the distributor on the script; specify Concerta authorized generic; Alza OROS
4. If I prefer brand/authorized generic Concerta, what are my options?
Much will depend on your insurance coverage. Many insurers require policyholders to accept a generic if available. Here are some options:
1. Call your pharmacy fulfillment company and ask the price for the generic and the brand.
Also learn the price for home-delivery, typically a 60- to 90-day supply that is cheaper than the monthly cost if purchased at the local drugs store. Yes, you CAN order stimulants via home-delivery. I write about it here: Tip: Home Delivery of Stimulant Medications
2. If the brand is affordable:
Ask your prescriber to request an “exception” based on medical necessity.
A doctor can request by letter that the plan cover the medicine “by exception.” Even though the medicine is not on the plan’s formulary, the physician contends that another medicine will not work as effectively for you. For example, you are allergic to the other medicines on the formulary.
Unfortunately, sometimes it’s necessary to try the generic first. But if the previous Concerta generics have been tried, to poor effect, mention that.
Also explain if other stimulant medications were not satisfactory, including those in the same class as Concerta (methylphenidate products such as Ritalin, Quillivant, Daytrana, etc.) and the amphetamine class (Vyvanse, Adderall, Dexedrine, etc.) . Assuming, of course, that others had been tried before settling on Concerta; it might be that another medication will work better.
3. If the brand cost is prohibitive:
Check to see if you qualify for financial assistance from Concerta’s manufacturer:
You can also look for the best price available at GoodRX
5. How will I know if I have brand/authorized generic Concerta?
Simple! Concerta pills will say “Alza”—the name of the company that owns the OROS technology central to Concerta. Here are photos:
Brand ConcertaA reader kindly sent to me a photo (below) of her recently filled prescriptions for Concerta: two strengths of the Trigen Concerta generic. Notice: The pills do not say “Alza” and they are not the same shape as the brand Concerta.
Trigen’s generic for ConcertaThere does seem to be a hole in each tablet, but that is not indicative of Alza’s OROS technology. A reader suggests that this looks like an older technology for osmotic release.
6. Argh! My pharmacy still substitutes the downgraded Concerta generics? Isn’t that illegal?
Despite the FDA’s ruling, some pharmacies have persisted in foisting the downgraded generics from Kremers-Urban and Mallinckrodt on unsuspecting consumers.
Here are some options:
- Present the pharmacy manager with the FDA Drug Safety Report. If you print it, note my yellow highlights and replicate them on the photocopy.
- Contact your mail-order pharmacy (if applicable): If your health insurance includes a mail-order option (typically, 60- or 90-day supply), ask the price of brand Concerta if it is required by the physician (sometimes it costs more if the consumer, rather than the prescriber, requests brand). (Tip: Home Delivery of Stimulant Medications.)
- Ask your physician to write “Alza OROS only” on the prescription; Alza’s OROS is the technology that makes Concerta’s delivery system unique. Another option, as referenced in the opening paragraph: The prescriber writes (for the 18 mg): Concerta Authorized Generic/Alza OROS.
- Ask your physician to indicate “no substitutions” on the Rx script.
- Complain to your health insurance carrier.
- Ask your physician to write a note to your health insurance company saying that you or your child experienced intolerable side effects to the downgraded generic and you must have the brand. (Be prepared to pay the brand price, though.)
For more information on these downgraded generics, please read this post: Consumer Q&A: Generic Concerta.
7. Hey, Gina, why are you making a big deal? By law, generics are the same as brand!
No, sorry. Generics are not the same as brand. No matter what some misguided pharmacists—and even physicians—might tell you. The generics might be bioequivalent — and even that includes a huge “margin of error” — but that’s not “exactly the same.”
There are three key differences, and they are particularly relevant to psychiatric conditions because the best results typically come within a precise dosing range (the “therapeutic window”):
1. Variable dose of effective ingredient:
In the U.S., the FDA requires the “bioequivalence” for the generic product to be between 80% and 125% of the original product. Yes, that’s roughly 20 percent up or down—a huge window of variance. Even that number will not be constant; it might vary each time the prescription is filled because pharmacies often switch suppliers.
This variability alone can wreak havoc for many people with ADHD. They might do best with a specific dosage; taking much more or less than that dosage is not as effective—and can even be very problematic. Especially when you’re not expecting it. And especially when you question the pharmacy about the different-looking pill and you’re told that generics are the exact same as brand. Wrong.
2. Different dyes, fill material, and binding
Branded drugs and their generics almost always contain different dyes, fillers, and binders. These are all ingredients to which many people have other adverse reactions. (I cannot cite supporting research, but anecdotal reports indicate that people with ADHD might be more prone to these sensitivities.)
Imagine when your physician has no clue that the filler is the problem, not the medication—and not some additional condition, such as bipolar disorder.
If you or your child is sensitive to dyes, please note:
-
-
- TriGen 27mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake.
- TriGen 54mg tablets contain: FD&C Yellow #6 Aluminum Lake, FD&C Red #40 Aluminum Lake, FD&C Blue #2 Aluminum Lake.
- TriGen 72mg tablets contain: FD&C Blue #1 Aluminum Lake.
- Mylan 27mg contains Red #40.
- Impax 18 mg contains yellow iron oxide (no mention of dyes; iron oxides are used in brand Concerta, too)
- Impax 54 mg contains red iron oxide and yellow iron oxide (no mention of dyes; iron oxides are used in brand Concerta, too).
-
I could find no evidence of FD&C # dyes in Concerta, though perhaps different names are being used.
According to brand Concerta’s FDA-required product insert:
In addition to the active ingredient (Methylphenidate). CONCERTA® also contains the following inert ingredients: butylated hydroxytoluene, carnauba wax, cellulose acetate, hypromellose, lactose, phosphoric acid, poloxamer, polyethylene glycol, polyethylene oxides, povidone, propylene glycol, sodium chloride, stearic acid, succinic acid, synthetic iron oxides, titanium dioxide, and triacetin.
Bottom line: It seems that the Impax generic Concerta tablets contain no FD&C dyes. They do contain iron oxides (as colorants, presumably), as does brand Concerta. The various doses are differentiated by color (e.g. white, reddish-brown, etc.). Read the product insert for the Impax generics here.
3. Different delivery systems—in “true” generic Concerta’s case, no OROS
Concerta and all Concerta generics contain methylphenidate (MPH), the same medication that’s in Ritalin. The difference is the delivery system—that is, how the medication gets from the pill to your nervous system. (You’ll commonly see the term CNS Stimulants—for Central Nervous System Stimulants.) The delivery system can make all the difference, including the rate at which medication is released.
The breakthrough technology behind Concerta is the Alza-patented OROS Osmotic [Controlled] Release Oral [Delivery] System. This is a laser-drilled osmotic pump in the capsule, proprietary to a company called Alza. You actually excrete the capsule; it does not dissolve, though there is an outer coating of methylphenidate, for faster release. None of the “true” generics have OROS.
8. Wait! My pharmacist says the Trigen generic does have OROS technology.
Yes, that’s what our home-delivery pharmacist told me, too. He was wrong. I had called to complain about my husband’s recent prescription fulfillment, containing round pills rather than oblong and without “Alza.”
You see, the prescribing physician has for years written, “OROS only” and “Actavis”. That specified brand Concerta, whether sold as a brand or the “authorized generic” from Actavis (the brand marketed as a generic).
“Did you read the script?” I asked the pharmacist. “Yes,” he said. “And I checked with the company (Trigen), which confirmed that they do use OROS technology.”
Okay, that’s a bit like asking the fox if he’s doing a good job of guarding the henhouse. But never mind. Did he read the product insert—the paper with all the fine print describing the medication, as required by the FDA?
“Yes,” he said. “The product insert confirmed it is OROS.”
But no, it isn’t. The pharmacist confused the general term “osmotic” with “OROS.” OROS is the trademark name for Alza’s novel osmotic delivery system.
OROS = Osmotic [Controlled] Release Oral [Delivery] System. Osmotic is just…osmotic — a process, not a proprietary delivery system.
9. So, Trigen uses the term “osmotic” but that’s not Concerta’s OROS technology?
Exactly. A company named Alza owns the OROS technology. And that technology is central to the way Concerta pills release the medication (methylphenidate) into the body. It is a proprietary technology, and extremely difficult if not impossible (so far) to mimic.
Trigen seems to be claiming the same delivery method as Concerta’s OROS delivery system—but is very careful never to use the word OROS.
My instincts are that Trigen hoped that sufficient buzzwords (see below, in boldface) would snow the pharmacists and physicians (as it did the CVS/Caremark pharmacist I spoke with).
Let’s Check the Product Insert
From the Trigen Concerta generic insert (the paper describing the medication, as per FDA guidelines):
11.1 System Components and Performance
Methylphenidate hydrochloride extended-release tablets use osmotic pressure to deliver methylphenidate HCl at a controlled rate.
The system, which resembles a conventional tablet in appearance, comprises an osmotically active bilayer core surrounded by a semipermeable membrane with an immediate-release drug overcoat. The bilayer core is composed of a drug layer containing the drug and excipients, and a push layer containing osmotically active components. There is a precision-laser drilled orifice on the drug-layer end of the tablet.
In an aqueous environment, such as the gastrointestinal tract, the drug overcoat dissolves within one hour, providing an initial dose of methylphenidate. Water permeates through the membrane into the tablet core. As the osmotically active polymer excipients expand, methylphenidate is released through the orifice.
The membrane controls the rate at which water enters the tablet core, which in turn controls drug delivery. Furthermore, the drug release rate from the system increases with time over a period of 6 to 7 hours due to the drug-concentration gradient incorporated into the drug layer of core of methylphenidate hydrochloride extended-release tablets. The biologically inert components of the tablet remain intact during gastrointestinal transit and are eliminated in the stool as a tablet shell along with insoluble core components. It is possible that methylphenidate hydrochloride extended-release tablets may be visible on abdominal x-rays under certain circumstances, especially when digital enhancing techniques are utilized.
Illustrations of Medication “Profiles”
There is something called a medication “profile.” Essentially, it refers to the timeline starting when the medication is taken and ending when all effects have stopped.
Below, see the “profile” that Trigen included in its product insert. Here’s where things get a little …complex.
If you didn’t know better, you might assume that this compares two profiles:
- Trigen generic Concerta, and
- Brand Concerta.
But no, this graph compares the profiles of
- Brand Concerta (Methylphenidate HCI Extended Release Tablets)
- Ritalin (Methylphenidate)—three doses of Ritalin.
If you didn’t know better, you might also draw the wrong conclusion from this graph: That is, the Trigen generic Concerta is superior to Ritalin in the same way that brand Concerta is superior to Ritalin. That is, less of a “roller coaster”.
Here’s the thing: Trigen simply lifted this illustration from the Concerta product insert. Again, that graph compares brand Concerta to generic Ritalin. It has nothing to do with the Trigen generic. Welcome to the wacky world of generic medication approval processes.
To go into more detail risks boring you to tears. Suffice it to say, some generic manufacturers put all their resources into exploiting FDA loopholes when it comes to novel delivery systems such as OROS. The previously downgraded generics made a cynical play. They were shut down, but only after much tumult in real people’s live and consumers filing complaints.
Let’s hope more people are aware now and, if their “Concerta” stops working, they’ll know where to look first.
10. We’ve tried one of the new generics and are very dissatisfied. How do I file a complaint with the FDA?
I encourage everyone who has experienced adverse events with these generics to file a MedWatch complaint with the FDA. This is how the previous generics were downgraded, so please make your voice heard.
Click on this link for “MedWatch Voluntary Report” and select “Consumer/Patient.” Follow the instructions from there.
For More Reading: Pediatrician Kristen Stuppy helped lead the effort to have the FDA downgrade the previous Concerta generics. You can read her post on the new generics here: New 2017 Generics for Concerta
302 thoughts on “Consumer Alert: Three New Concerta Generics as Janssen/Actavis Deal Ends”
Gina,
We are doing the generic Concerta roller coaster in attempts to get access to the Brand Concerta. Last time is was Trigen which was better than the nothing we had for a month trying to get the prescription filled. (Child is in college moving from pediatrician to school health center to doctor in town with school). Today the prescription was filled with Mallinckrodt. MALLINCKRODT! Is this the same ineffective version of Concerta that I complained to the FDA about in 2018 because it was completely ineffective for my child? The bottle says “Subsituted for Concerta” If there is a place to read more information, please direct me to it!
Thanks to your website, I had peace for about a year when I was receiving the Patriot brand through the mail. The pediatrician didn’t know you could get it delivered. We were both thrilled.
Hi Monica,
You’re welcome! Feel free to donate to my Paypal account. 🙂
Check out my latest post from January, where I covered the most recent changes: https://adhdrollercoaster.org/adhd-news-and-research/janssen-bombshell-ends-concerta-authorized-generic/
Yes, it is the same Mallinckrodt. The Trump administration’s FDA chief reversed that decision — and paved the way for a dozen new Concerta generics.
Good luck to you!
Gina
Hi Gina!
Our 24 year old son has been on Concerta since 1st grade. We had him fall off the rails in 2017 when they slid in the Mylan generic without us knowing. I submitted my feedback immediately and mandated the Activas/Teva/Patriot generic. He ran out of these in early March and I can’t find anything available other than Concerta for $2,720 per 90 days for the two scripts that make one dose. He is on the 54 and 36 to make one dose. In addition, I could only find Concerta 54 mg in stock. They had no date they anticipated getting the 36 mg by. Our son is special needs and only makes $17/hour when employed so $2,720 every 90 days is not a possibility. He only qualified for a $200 discount with Janssen. I’ve tried our local chains and ServeYouRX.com. I’ve looked at pricing from Singlecare and GoodRX, but am not having luck finding reasonable pricing. He lost his job of 2 1/2 years last fall when he had an interuption in medicine because it wasn’t available and he just lost another job a week ago. We are linking it to the lack of medicine.
Do you have any ideas for a mail order pharmacy we could try or a congressman we could contact?
Thanks!
Michelle
Hi Michelle,
Did you try my suggestions in the latest post on Concerta and generics?
https://adhdrollercoaster.org/adhd-news-and-research/janssen-bombshell-ends-concerta-authorized-generic/
If you can afford that, more power to you. If not, you might want to exhaust any “patient assistance” programs, through Janssen or state agencies:
https://www.janssencarepath.com/patient/concerta/cost-support
As far as sheer accessibility, the national home-delivery warehouses typically have more ample supplies or hard-to-get Rx than local pharmacies do.
Maybe it’s not the best strategy to keep chasing Concerta. Look into alternatives beyond the Concerta generics (though it’s possible one of them might be useful, you. might have to go through many to find it).
good luck
g
There are no holes in those generics because they’re covered in drug overcoat. If you leave the tablet in your mouth for a minute and look at it, the hole will be obvious.
Hi there,
Thanks. Yes, good point.
I think the issue is rather that the evidence of holes is so irregular. That alone seems to point to a not-exactly-precise manufacturing process.
Also, how long does it take to dissolve that coating? I imagine this differs among individuals.
g
Here’s a wild tale for you about Trigen. Recently, their generic has been all I’ve been able to get. I’m not even sure what the point of taking it is but I guess it helps me sit a little more still in meetings.
Regardless… I took my pill on Friday at about 5AM. At 3:30PM I had a doctor’s appointment where they tested my urine for methylphenidate. IT CAME BACK NEGATIVE.
Even if somehow missed my dose on Friday (which I’m pretty sure I took), I KNOW I took it the day before.
I filed a report with the FDA. This blew my mind.
Hi Kristina,
Interesting. That’s the first time I’ve heard of a test for methylphenidate. It’s typically not a “drug of abuse” so no job-related screening.
I’m unclear about your MD’s goals in such a test. MPH tends to clear the system pretty quickly. That 10.5 hour time-lapse would make a blood test for MPH meaningless. But urine testing seems a different issue….farther down the pipeline, as it were.
Was it something like this — a stick test? : https://www.narcocheck.com/en/urine-drug-tests/methylphenidate-ritalin-test.html
g
Gina said she hasn’t heard of a urine test for Methylphenidate?
Absolutely . Controlled substance, usually means there is a substance agreement in place with the prescribing provider and they can and often do order random drug testing and every drug test Ive seen or run as a nurse and also as a patient for work or otherwise includes testing that would identify Methylphenidate and other stimulants.
Depending on your metabolism and how you clear this medication it is possible that with hydration and 24 hours you could test negative, but with a time release formula and same day dosing I would absolutely expect there to be at least detectable amounts in your urine.
Make sure your drug test did include that profile however as there are numerous drug screenings and Tox screens and each has its own things its looking for.
Very concerning if you tested neg though and they did test for it. Glad you reported it!
Thank you for filling us in, Kimberly!
To clarify, of course I’m long familiar with drug testing ++ just not for moh, which is not typically a drug of abuse, compared to amphetamines.
Gina
Gina,
Your comments about the “Illustrations of Medication Profiles” provided by Trigen Labs are (still) right on. The bigger issue is that the plasma profiles in those graphs are for REAL JANNSEN CONCERTA, NOT the TRIGEN LABS KNOCKOFF.
The graphed curves appearing in the Trigen Labs product (NDC 13811-709 Methylphenidate Hydrochloride Tablet, Extended Release Oral) package insert (see https://ndclist.com/ndc/13811-709) are precisely COPIED FROM the Janssen Concerta insert without attribution (see https://www.janssenlabels.com/package-insert/product-monograph/prescribing-information/CONCERTA-pi.pdf#page=21).
One wonders what the actual pharmacokinetics of the Trigen Labs MPH ER products are, and why they could not be bothered to show their actual work. Charitably, maybe they did the work, found it didn’t look right, so they copied the smart kid’s homework to turn in to their customers. Back in the day this was called falsifying data and usually had consequences. Meanwhile we unwilling consumers of the Trigen Labs MPH ER products are left with a “…shoddy … casing full of used pinball machine parts.” [1]
The other point is that the release mechanism described in Trigen’s literature is on its face is a poor paraphrase of a description of the OROS system in Janssen literature. There’s no wonder consumers find it to be less effective than actual OROS-based products.
Cheers,
Rick
1. Zemeckis, R. (Director). (1985). Back to the Future [Film]. Amblin Entertainment.
Hi Rick,
Thanks for pointing that out. I think I explained it in another post on the Concerta saga.
They don’t have t “show their actual work.” Just an approximation of hitting that profile was enough!
When I was first trying to figure out what was happening, I called a pharma patent attorney. He explained that these generic manufacturers were exploiting loopholes….”It’s brilliant!” he said.
“If you’re a sociopath,” I said. 🙂
g
You should never bash a medication just because it wasn’t right for you. I was started on Trigens 18mg and it was a miracle pill for me at 45. It has changed my life!!! But upon refill i was given another ER from another mfg and in 1 hour i had serious physical agitation , and anxiety joined the party later in the day- my family avoided me all day and i felt terrible- i trashed the pills. I tried another and it is a subpar version, it helps but makes my paralysis worse ; so im getting through my days , but it’s crap compared to Trigen- for me! Now I’m fighting to get the Trigen again and how i can get it consistently so I can function- i even contacted Trigen for help. Everyone’s brain is different and practioners need to pay attention to what brand / mfg of the drug works for their patients and keep it consistent , and pharmacies need the freedom to purchase what patients need consistently. Its not fair to anyone with ADHD to be handed different versions of the med that could cause serious disruption to daily functioning 🙂
Hi Meg,
I don’t think anyone is “bashing” a medication just because it wasn’t right for them.
Rather, people who have used Concerta to good effect should not be stuck with a random generic that in no way resembles Concerta.
That is the issue — the lack of these generics’ bioequivalence to Concerta.
For people using the Concerta generics — to good or ill — they will still be affected by the loosey-goosey “bioequivalence” among the 20 or so Big Generic companies cranking out these pills. Mostly off-shore.
good luck finding what works for you,
g
My local Walgreens (Texas) only has brand and they do not currently have any generic available. All generic Concerta have been back ordered for the past 2 months. I was paying $10 for authorized Generic and last month I paid $269 for branded Concerta. This month branded will cost $602. I have insurance and used the manufacturer savings card each time.
Since generic isn’t available and branded is to costly. Any suggestions – of anyone doing well on Concerta and also doing well on a similar Stimulant. We are considering the Quillivant for our son. He has done fantastic on Concerta for the past 10 years. Hard to change when something is working so well.
Hi Lisa,
I definitely appreciate the reluctance to change. So much hangs in the balance.
I linked to some alternate MPH choices in my latest post:
https://adhdrollercoaster.org/adhd-news-and-research/janssen-bombshell-ends-concerta-authorized-generic/
As for reports from others, in a sense, it’s not useful. Drug response is highly individualized and dependent on many factors, including genetics.
While most people who did well on Concerta seem NOT to be doing well on the Concerta “generics”, some do better.
I’m afraid it’s trial and error, taking educated risks. I detail the the entire range of stimulants and mechanisms of action in Course 2 – on ADHD Sleep and Medication.
I’ve seen this information available nowhwere else. That’s why I had to create it. Because too many prescribers lack sufficient expertise.
good luck,
g
Im with you Meg. I am fighting to find the OSM tablets vs the brand OROS tablets. Good luck. I haven’t had much.
Hi Meg,
Try being a severe narcoleptic and wonder why every time a new prescription is filled, it works different. I thought I was going crazy. I am at least going to try and get used to one of these generics. The latest this year is Trigen and I see the holes BEFORE they are put in my mouth. Consistency is what I need. Driving without a dependable/consistent med and having narcolepsy is dangerous.
TK
Around a year and a half ago, I was suddenly changed to a 214 labeled generic of Concerta from the alza. Noticed my mental health deteriorating, depression coming frequently and in 2020, suicidal ideation. I’m still struggling with it despite no other things in my life changing. When I don’t take it, the depression never occurs. Alza made me feel more alert and focused. We’ve used Walgreens all my life, but I tried calling them today about it once I realized it might be the pill’s fault, to get it changed back to name brand, and they said they had the option to have brand or generic shipped to them, and generic was now the one that was selected. I don’t know what to do…. The other walgreens near me say they won’t stock brand. I don’t know what to do….
Hi there,
How much is the brand?
Also: It’s IMPORTANT not to ask, “do you STOCK” the authorized or brand?
Most pharmacies aren’t stocking any stimulants. They order them, reserving a modest supply for immediate fills.
Also: Check out the savings program: https://Concerta.net
g
I found this article after looking up the generic Concerta ( Trigen labs 36mg) CVS refilled my Rx without my consent. Let me begin by saying I may very familiar with the practices in the pharmaceutical industry. I went to nursing school to get a free education to transition into the pharmaceutical sales career that I loved for over 20 years. I battled generics in the cardiology offices everyday. Once a week, a cardiologist would verbally dress me down about my product failing his patients after he got them stable on it in the hospital and then 2 weeks after discharge, they were back in the hospital from my drug failing to work. I surprised numerous doctors because I barked back! I asked just one question, ” how did you sign the patient’s discharge rx? “DAW” or Substitution Allowed?” All that were honest admitted they allowed generic subs. I would then verbally dress them down and tell them to take their frustration to the source, generics! Yes, it angered them and one threw me out of his office, but after 2 years of barking back, I earned respect from most of them. The largest office even required all patients to physically bring their bottles to the visits with them. I challenged each office to do your own study and I would supply brand name meds to conduct it with. They learned quickly that generics are NOT the exact same as brand. If there only one generic for a product, they could learn to use it and be ok, but life isn’t that simple as there are too many generics for each product and all vary! Pharmacies buy what is cheapest that month and sub it until they reorder the new cheapest available, so no consistency to learn. I am currently battling CVS as I write this and will be a thorn in their side as long as I need to be! Remember this, the signature line says ” May Substitute ” not Must Substitute! I have known to be key meds in brand name only for years and doubt I get any Christmas cards from CVS this year! Oh well, I will live without it! Have your readers to always ask doctors or staff for any “vouchers” from the drug companies to get discounted brand products. Most have them actually, but never tell or remember them.
Hi David,
Thanks for sharing your story.
I’m not sure if you understand: This is more complicated than simply brand vs. generic. There’s an authorized-generic. That’s not so common.
If the prescriber specifies, “no substitutions,” then you will get brand.
The prescriber needs to specify Patriot brand (it’s not a brand, it’s a distribution arm of Janssen, but anyway…).
If you read the post, early on you’ll find a link to the Janssen savings program for Concerta brand. I’ve found that many prescribers don’t use the vouchers anymore—and typically they require more paperwork.
The savings programs are pretty streamlined.
cheers
g
Calling patriot pharmaceuticals tomorrow as can’t find the authorized generic locally. I 100% agree with the comments. The generics were held up at FDA for not having right equivalence during the 12 hour period.
Locally, I tried rite-aid, cvs plus other supermarket/small stores but no lucky. Walgreens did have but happens to be the only Pharmacy not in our plan.
Hi BethAnn,
Just FYI – Not all the comments here are accurate, and some are dated. As the author of this blog, I try to make sure readers get the facts.
It was me who opened the initial MedWatch file and together with ADHD Roller Coaster readers, the first two inferior generics were downgraded by the FDA.
https://adhdrollercoaster.org/tools-and-strategies/victory-concerta-generics-downgraded/
It’s an entirely different ballgame now. The Trump Administration FDA chief overrode FDA scientists’ concerns about bioequivalence with these novel-delivery system medications — and pushed through many generics. It’s unlikely we can do anything to roll this back.
That said, I do believe the FDA staffers do care about these things and they will guard that data for such time as it is useful.
Gina Pera, Adult ADHD author, expert, and educator
So frustrating dealing with any pharmacy. After getting handed Trigen OSM and refusing it, I thought I had gotten my physician and Walgreens trained. But then Walgreens substituted Actavis-Teva ER and labeled it OSM! The new version of Teva ER is a hydrogel, not OSM and not OROS. I called to pharmacist at Walgreens and she looked up the NDC number in her system and it states OSM. I explained to her the history and she was unawares. I confirmed that the drug effectiveness data in both Teva and Trigen documents just copied the Concerta data and relabels it. That is not how science is supposed to work to show equivalence! Back to the drawing board.
Hi Philip,
So frustrating, I know. I’ve been at this for years.
Science doesn’t work like this. FDA scientists were lobbying for updated guidelines for generics of sophisticated delivery-system drugs (e.g. Concerta).
We successfully campaigned for the FDA to downgrade the first two inferior generics.
Then a new administration came to the White House — and a Heritage Foundation fellow was appointed as FDA chief. He dismissed the FDA scientists’ concerns and pushed through dozens of generics — before heading back to the Heritage Foundation.
Elections have consequences.
We can and should do better.
good luck,
g
Hello there,
We got fed up with this situation after years of fighting. When Walgreens finally switched to the generics that don’t work, we talked to our pediatrician and did a trial with Aderall for both kids. It actually worked better for them, better appetite, sleep and focus.
Hi Miriam,
Few prescribers follow a rational protocol in identifying the best Rx for their patients who have ADHD.
They fail to even try a choice in each class — much less two, as would be advised given the difference in delivery systems.
I’m glad you solved your problem and ended up with a better outcome.
g
Gina,
That’s out of pocket cost
So by “out of pocket” cost, you mean not covered by insurance.
Typically, I think, “out of pocket” refers to the costs the insured pays ….more like the co-pay.
g
In response to ‘Steven Holt’, Hy-Vee Pharmacy carries Patriot..out of pocket was about $120 for 36mg for 30 days as of September 2019.
Wow, that’s a very high price, Amy. It might be better, if you have a home-delivery benefit, to pay for 90 days of brand.
All insurance policies are different, of course. But it might be worth checking out.
thanks for the tips,
g
I have gone through ALL of the major pharmacies over the years to get my son the authorized generic: CVS, Walgreens, various independent pharmacies, Costco, Target, etc. Our last chain in the area that would order it and get it is Walmart, for the last six months. Now they can no longer get it.
The pharmacist specifically orders the authorized generic for us, but the last few times it has not come in; and she told me that it is their supplier, McKesson, who decides what they get and when they get it.
I see no reason for her to lie to me; and she is not the first pharmacist to relay this to me.
So, I find Derek’s assertion about the distributors’ power to be plausible and likely. Our insurance will only pay for generic, and we tried the doctor’s letter in order to get the brand and were denied. They will only pay for the generic; and no one in the whole Los Angeles area now carries the authorized generic, so we are absolutely freaking out.
We can’t afford the brand. My son is terrified–he is supposed to start community college this year and if we can’t get his medication it’s not even worth going. We are talking about him working for a year and not attending college, and saving his money so that he can pay for his medication himself next year.
This is so unfair. I have had to jump through hoops and kill myself for four years getting his medication. We have tried the horrible generics more than once.
In the beginning we didn’t know why his medication wasn’t “working” like before–but then I learned all about it, and it’s been a nightmare getting it ever since.
Best, Veronica
Hi Veronica,
I hear your desperation. It’s why I have devoted a lot of time to reporting over this issue for several years now.
When we freak out, though, we don’t always think clearly. We might tend to latch onto definitive (but wrong) answers.
You can either trust a random person on the Internet who presents an authoritative-sounding explanation—or you can trust me and the other readers who have found success. Your choice.
It might be true that some retailers make deals that circumscribe their choices (perhaps bringing greater discounts). But that does not necessarily mean it’s true for 100% of retailers.
Check out these comments. People are managing to get the authorized-generic distributed by Patriot. That is a fact.
It might be that you need to be very specific with your preferred pharmacy, Wal-Mart. You might need to inform the store that the distributor has changed and give them the NDCC number, as I explain in the post. Print the entire post and bring it to the store, so they will have all the necessary information.
Or, you might need to try another chain. Walgreen’s seems to be the better bet, going by reports.
I’m pretty sure that all of Los Angeles does not have a black-out on the authorized-generic.
good luck,
Gina
When you read “CVS Health is the nation’s premier health innovation company” on a press release regarding Aetna, you know it is pure BS. We have Aetna and I was not aware of the merger: very frightening story. There was a recent journalism article in the local paper about how CVS would not fulfill the prescription orders for a cancer patient. The frustrating part for the Oncologist was that he could never speak to the person/group/entity within CVS about the drug denial. The same old situation where the person you get on the phone cannot connect to the decision maker.
This is really really bad.
Go Bernie go!
dk
ps: Both CVS and Walgreens do not stock the proper Concerta for my son anymore but RiteAid does….. for now.
Hi Dana,
As an advocate who has heard from people with ADHD internationally, I am not an advocate for single-payer.
Beyond the fact that no country even approaching our size has it, we surely cannot switch now.
I’ve seen how certain countries with single-payer NHS have politicized ADHD so as not to provide treatment. That means people do not get the treatment they deserve.
FYI – Did you know that Canadian NHS does not include medications? Moreover, Canadians have a fraction of the choices that we have in the U.S., which means an individual is less likely to find an option that works best for his or her specific needs.
These are the stimulant options for Canadians:e:
1. methylphenidate (Ritalin®, Ritalin SR®, Concerta®, Biphentin®, generic agents)
2. dextroamphetamine (Dexedrine®, Dexedrine Spansules®)
3. mixed amphetamine salts (Adderall XR®)
Would you truly have wanted the White House and Senate of the last two years to be making all your healthcare decisions? Just the thought frightens me.
The ACA was headed in that direction of the systems considered the best (i.e. France, Germany, Switzerland) before the Republicans sabotaged it at red-states level. It’s called the Bismarck model, and it consists of non-profit and highly competitive insurance companies, regulated prices for medication and procedures, and a public option.
In the UK, one of the few countries that has single payer, hundreds of thousands of children and adults with ADHD are denied treatment. When you leave healthcare decisions to the politicians, you might not like the results. 🙁
g
For now is correct, I just had my Rite aid switch brands last week and they told me since Covid hit they do not have any more power over suggesting certain medication brands to stock. What the parmaceutical companies send is what they get. I dealt with a switch like this last year and the “other” generic Teva was giving my son horrible headaches to the point he couldn’t function. I called every pharmacy around and rite aid had the patriot brand so we switched pharmacies. Now last month they went to trigen brand and as of 2 weeks ago he started getting headaches again. I dealt with 10 phone calls back and forth with the Dr yesterday as she was aware in the beginning when they switched that this trigem brand wasn’t as effective. And the other day I decided to call around again, bc I’m his mother and will do everything in my power to help him. I found a walgreens that carries the patriot brand again but the Dr. doesn’t feel comfortable sending a new script bc the other was just filled on the 21st! How pathetic. I’ll bring you in the old script to prove I have it if that’s your concern! I am not happy and will be doing everything I can to get this taken care of. It’s so hard to see your child struggle bc the efficacy isn’t the same and now having headaches again on top of it and yet the Dr won’t do anything except send us to a psychiatrist to get it figured out. I’m going to call the psychiatrist and speak with him bc he is the one who originally put my son on the concerta and it has been the only thing that has worked for so long with out being adjusted! As long as you have the brand of course!
Dear Sharon,
I hope that doctor “gets comfortable” with treating her patients!
But here’s the thing: It might be counter-productive to ask if the Rite-Aid pharmacy CARRIES the Patriot Concerta generic (this is the brand sold as a generic, via a marketing deal).
Few of them CARRY it — that is, keep it in stock.
Instead, you want to ask for them to order an “exception process.” If you run into brick walls, call Patriot: 215-325-7676
Ask the prescriber to specify the NDC#. It varies by dosage (the databases used by pharmacies sometimes use a slightly different version of these numbers, with an extra 0 perhaps):
10147-0685-1 – 18 mg
10147-0688-1 – 27 mg
10147-0686-1 – 36 mg
10147-0687-1 – 54 mg
You might also have better luck with Walgreen’s.
Good luck,
Gina
It’s interesting to read so many opinions, co-mingled with facts and stats, but majority personal experiences…. and the conclusions folks come to based on personal experiences or opinions. Plus the “pile on” effect of digital communications in this era, and group think / confirmation bias dynamic.
For one, I’m not here to endorse any brand of methylphenidate ER, generic or brand. Second, I actually prefer and get scripted adderall anyway, I trade a coworker a few each month for her IR 20 mg ritalin…I work in marketing at a media startup and do a lot if copy writing AND statistical analysis/reporting….simply find adderall allows me to write better and faster, but prefer adderall for most other job duties.
It’s absolutely true that not all generics are created equal. It’s absolutely true that the Brand Concerta’s patented release technology is superior to most any ER system on the market, even the highly diverse opioid pain reliever and gastro med markets. Its also true that the FDA tends to slap equivalency ratings on generics waaaay too liberally and then a__ backwards has to rescind those ratings later.
What’s not true and where folks begin to speculate with frankly no facts or data to support their remarks is the reason cvs or other chains carry certain brands.
I’ve seen multiple posts that cvs “has better margins” on “makes more $$” on generics like trigen… people hear me out on this, chain pharmacies DON’T EVEN HAVE TOTAL CONTROL OVER THE GENERIC BRANDS THEY STOCK!!! that’s a fact! The power lies with the distributors and insurance companies. They control:
1. The supply
2. The price chains bill your insurance for meds
3. The brands that chains stock, and
4. The inventory and availability that limits our ability to get the brands we want.
In other words, CVS does NOT stock Trigen or any other generic ritalin ER because they make a better profit on it; in fact, that’s not even a remotely relevant factor in what brands are in stock at each chain. The TRUTH is that distributors (think Mckesson, Cardinal, et al) dictate not only what brands the chains get, but also which brands chains can stock or not stock at any given time. This goes far beyond the profit driven motivation of cvs or walgreens, this is more of a monopolistic dictatorship where distributors will simply LEAVE CHAINS OUT OF STOCK if they don’t reorder the brands the distributor dictates.
This is why theres been so-called shortages of adhd meds, esp adderall, in the last several months. Cvs isn’t allowed to get teva (i get 10 mg or 20 mg IR depending on stock) or mylan generic adderall in some cases. Not enough room here to dive further into the weeds on this but this is a good read and summary of the POWER the distributors have, NOT pharmacies! https://www.ncbi.nlm.nih.gov/books/NBK202523/#!po=6.77419
Thanks for writing to share that information, Derek. I will read the paper with interest when I get a minute.
I’m sure that some pharmacies, or pharmacy chains, face the issues you describe.
Others, however, do not.
CVS has consistently been the bad actor on this issue, for years, including forcing customers to accept the FDA-downgraded Concerta generics as a legitimate substitution. Illegally.
Aetna’s CEO received a cool three-quarters of a billion dollars for arranging the sale of Aetna to CVS.
I don’t worry about CVS being powerless against McKesson or any other distributor.
As one reader reported just today, his CVS pharmacist tried to go to bat for him in getting the authorized generic. Ultimately, Headquarters said not, it’s not a “cost-effective generic” for them.
By contrast, Walgreen’s has been more reliably customer-service-focused in helping customers with the authorized-generic prescriptions.
Obviously, the distributors’ power is not absolute.
So, while I appreciate your taking the time to write, I need to balance your assertions with what is actually happening on the front lines.
By the way, I don’t write about innuendo and rumors. I get the facts as best I can. I find it’s best to be humble with one thinks one knows.
thanks,
Gina
Hi Gina,
Thank you, this post is so helpful! As you’ve described, I was filling the Actavis generic from Walgreens and getting the pills that say “Alza” until this last month when I filled my RX and noticed the bottle said Teva, and the pills appeared different. They definitely do not work in the same way.
The bottles I used to get (with the Alza pills) said Actavis on the outside, not Teva. Is it appropriate to assume that those were left over from before Teva purchased Actavis? The reason I ask is because I called Walgreens today to request the authorized generic with the information you provided. They told me they have both Teva and Actavis (as if they were two separate versions), and they’d make a note that I prefer Actavis. I asked if the pills said alza, and he said they did (although I’m not sure whether he looked at the pills, or a picture on the computer). I’m confused because your post says that Teva/Actavis are now the same, but my pharmacist seemed to think they were different. The only thing that makes sense is that the Actavis bottles that my pharmacist found in stock are left over from before the purchase by Teva?? In that case, they should still be the authorized generic, right?
Just want to be sure they are the correct ones before I go to fill my RX next week… Thank you again!!
Hi Heather,
Yes, I know it’s confusing. I tried my best to detail it clearly in the post. But still some people are confused — I suspect because they are getting conflicting information from confused pharmacists.
I’m afraid consumers will have to educate the pharmacists — and many physicians.
There are many variables here, especially as the new distributor (Patriot) ramps up and as Actavis exhausts its supply of the authorized/branded-generic.
Teva purchased Actavis, but I’m not sure that the box/bottle label ever changed, from Actavis to Teva. Actavis was simply operating as a subsidiary.
Please tell them to ignore the distributor! That is important only if they don’t know how to order from the distributor (it is now Patriot).
Please give your pharmacist the NDC codes I list in the article for future orders.
If there is still leftover stock from Actavis, tell the pharmacist to look for ALZA on the pill. That is the key. Ignore all else!
If he was blowing you off on having looked, ask him again.
Good luck and good for you, for thinking ahead!
G
The last 2 prescription fills I received where with Teva’s 54 mg ER OSM tablets. I have been on concerta for 3 years without issue. These last 6 weeks I have experienced significant anxiety and elevated BP. Your blog is leading me to think I need to get back to my previous branded medication. Thank you so much as I had no idea of the implications going from one manufacturer to another.
Shew! I’m so glad you found my post, Gianni.
I saw so much horrible human fallout with the first two Concerta generics….and they had no idea. When you’re told by your physician/pharmacist that “it’s exactly the same,” the logical response is looking for other factors causing the problem. Argh.
g
June 11, 2019….Just came from Walgreen’s where I picked up both 54 & 36 mg Actavis/Teva generic concerta for our 13 year old. Pills are NOT barrel shaped like previous alza/actavis. Pharmacist called their supplier and was told that since Teva/Actavis acquisition, the generic OROS pills are being phased out. she was able to find some in stock in the area, but was told that Teva is no longer making the OROS delivery system capsules…..Can anyone else confirm this?
Hi Larry,
You’ll find all the details in my latest post: https://adhdrollercoaster.org/medication/authorized-generic-concerta-update-yet-another-6-1-19/
Bottom line:
1. We need to stop referring to the OROS-authorized generic as Watson/Actavis/Teva…..those are just the sellers. NOT the manufacturers.
2. Teva never made the OROS Concerta; it simply sold it.
3. This is especially important to understand now, as Teva makes it’s own generic (“true” generic, not “authorized” generic, which is what you’ve been getting); if you ask for that, you’ll get the non-OROS generic.
4. The seller of the Concerta authorized generic is now Patriot Pharmaceuticals.
Read the post for more details — and tips on how to best specify the authorized generic (OROS).
Good luck!
Gina
Hello,
Been taking Concerta since the year 2000. Always had the ALZA 36tab. Have always filled at Walgreens.
Just received the TEVA 36mg which are marked with a triangle & 726 on the side.
They absolutely release entirely different. It takes much longer to kick in, then it all kicks it as once several hours later.
Called walgreens & they said they are switching to only carrying the Teva brand.
Pharmacist tried to tell me the delivery system is exactly 100% the same and that after the last Concerta generic issue in 2014 they made sure all the new generics have same delivery system. But after 4 or 5 days of trying, This medicine is absolutely different with how my body reacts. Pharmacy told me there is nothing they can do. Doctor says its a controlled substance and he can specify on the script the ALZA tabs but I have to wait 26 more days. Called the pharmacy back and was told even if you get the script good luck trying to find someone that stocks the ALZA tabs as they are becoming rare. Super bummed. What online pharmacies do you recommend.
Hi Steve,
Thanks for the first-hand report from the front lines. 🙂
I’m sorry you’re encountering this.
Walgreen’s has a MUCH better track record than the other chain pharmacies in this regard. But, it’s possible (likely) that “Big Generic” has so gamed the system that Walgreen’s can no longer justify filling authorized-generic Concerta orders. An independent pharmacist tells ADHD Roller Coaster readers that they LOSE $100 on each prescription. This is because insurance reimbursement is based on the lowest-price generic (aka, the inferior generics).
Two things:
1. If you have a home-delivery pharmacy benefit, I encourage you to use it. These massively large operations have more access to more distributors and might enjoy better pricing. If it works, it is such a relief. You go through this only 4 times annually (if you have the 90-day supply option) instead of 12 times!
https://adhdrollercoaster.org/tools-and-strategies/stimulant-prescriptions-via-mail-order-pharmacy-maybe/
2. Since you have tried the Teva generic and found it dissatisfactory, please consider filing a complaint with the FDA’s Medwatch. This is how we got the first two inferior generics downgraded. There are seven now, which seems overwhelming to counter. But I suspect this is the only chance we have.
https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda
I hope this helps.
g
I was able to get a new script from my family physician for the remaining 24 days until my next 30.
Went to:
Walgreens, Cvs, Walmart, Kroger, Target, Costco.
All of them only had
TEVA or TRIGEN
Found 1 out of several locations of the above retailers ( I live in well populated area with many locations ) pharmacy that stocks brand:
It cost $498! Insurance says they will cover it down to $60 ( I was paying $10 for generic )
However, they said I was getting the last stock they had.
Where are people finding the patriot pharmaceuticals?
I do have online through medimpact so maybe they will have.
Thanks
HI Steven,
You lucked out.
Much will depend on the quality of your insurance plan. Access to the more expensive authorized-generic will vary according to the policy, it seems. It’s all about cost.
If it were me, I would not even bother with local pharmacies. Especially every month. What a nightmare.
As I wrote in this post, your best bet might be to start getting the prescription filled via home-delivery pharmacy. They have more access. And, if you’re paying for the brand, it should be cheaper for a three-month supply (per month) than getting it one month at a time.
https://adhdrollercoaster.org/tools-and-strategies/stimulant-prescriptions-via-mail-order-pharmacy-maybe/
BUT….for the time being….Patriot Pharmaceuticals seems not to have its act together, at least yet. I asked a major home-delivery pharmacy to check access, by giving them the NDC number, and it doesn’t even come up for them.
Maybe the supply lines will become more reliable in a few months. Maybe not. 🙁 My best advice: Get the brand for a while, if nothing else and if it is affordable.
Stay tuned.
Thanx for responding. So I guess that if its the true generic it’s still gonna be Concerta & basically I’m still taking Concerta but not as strong. So at this moment I basically have nothing to worry about as far as taking the true generic the next day after I’ve took the brand name. Is that what your saying?
Hi Marcellus,
I know this is so confusing! I wish it were simpler. I try to break it down. But folks still remain confused. Perhaps if they hadn’t used the word “true” to describe generics!
It’s not “still gonna be Concerta.” It will be methylphenidate (MPH), the medication in Concerta, Ritalin, Quillivant, etc. The difference will be in how it’s delivered to the system. The brand/authorized generic uses a sophisticated delivery system that creates a smooth up and down, while the true generic uses something much simpler. Some people compare it to Ritalin LA.
Check out questions 1 and 2 in this post (where I cover a LOT of ground on brand, authorized generic, true generic, etc.
https://adhdrollercoaster.org/adhd-news-and-research/consumer-qa-on-concerta-and-generics/
Bottom line:
1. it’s the same medication
2. But it’s released into the bloodstream in a different way. That means you might get too much at once, not enough later, etc. At any rate, it won’t release exactly like Concerta.
g
Thanks. I read the post. Now all I’m concerned is what will I do now. Because i gotta take the true generic & I’m scared what would it do to me if I take the true generic the day after I took the authourized generic. Plus I don’t skip days so that doesn’t help.
Hi Marcellus,
So, if I understand correctly, you are concerned about what you should do RIGHT NOW: Take the “true” (inferior) generic or not.
I’d say that depends on
1. the severity of your ADHD symptoms
2. how well you are expected to perform at work/home
3. Whether you’re better off with NO medication or a medication that might not work as well as Concerta but is better than nothing.
It’s not that these “true” generics are harmful. They just don’t work as Concerta does. For some people, they might actually work better than Concerta. For others who do very well on Concerta, they might experience a negative difference.
I hope this helps.
g
Hello,
I have recieved the authourized generic for a whole year from Walgreens. Just today, everything began to change. I received the Teva generic instead of the authourized generic. I usually ask them if they could prescribe the Actavis generic but I didn’t because I had faith they would give me the authourized generic as they know that’s what I wanted. I was very disappointed about that. What should I do & where should I go to make sure this won’t happen again?
Hi Marcellus,
Darn. Sorry you have to deal with this.
Please read the post. It’s all there. Give Walgreen’s the list of distributors that I provide.
But also know, Walgreen’s is probably losing money filling that Rx, so it might not continue.
Home-delivery pharmacy might be your best bet, if you have that option.
g
I was told tonight from a Walgreens pharmacist they all carry Teva currently. Hy-Vee carries Patriot.
Pharmacies will often select one generic to have in stock. But they can often order from elsewhere.
g
Hi Gina,
My daughter has been using a generic form of Concerta 27mg for 6 months. The pill is round with a drill hole and has the letters AL. Is this pill an authorized generic/can you deduce who manufactures it from the description? Thank you!
Susan
Hi Susan,
In the mot recent post on Concerta generics, I make very explicit: If the pill doesn’t look like the one in the photo, it’s not the authorized generic or brand (which is one in the same).
https://adhdrollercoaster.org/medication/authorized-generic-concerta-update-yet-another-6-1-19/
In other words, if you don’t see “Alza,” it’s a different type of generic.
From the list of 7 Concerta generics in that post, above, I would guess it’s the generic from Alvogen Pine Brook, given the AL you say is on the pill.
To be sure, check the label on the bottle.
If she is doing well on the pill, there’s no problem. But if she’d previously taken the brand Concerta, switched to this generic, and has been doing less well, that might be the culprit.
Good luck!
G
Hi Gina,
Thank you so much for your extensive research on this topic. You have been a life altering angel!
My 17yr old son was diagnosed with ADHD Sept 2018. He was initially on Actavis up until March 2019. Since it has beena disaster where despite the doctor requesting the insurance to cover Actavis (which they do when dispensed correctly from the pharmacy). The pharmacy has given me the run around!
Twice I was dispensed Mallinckrodt. The first time March 2019, he tried the new medication after the pharmacist repeated over and over that is was the same thing. We it was not! Mallinckrodt caused my son to feel so drained, tired and dizzy after less than 2hrs! I was like really?! I felt he was probably lying, but after he turned down activities he usually turns down I knew something was not right. (That is when I landed here)
A few hours after the incident I went armed with information you provided. At that time proper arrangements have been made with dr and insurance to keep Actavis. April 2019 I was dispensed Mallinckrodt again! despite having a note on his chart! (Now im worried they may overlook allergies too ♀️). Now May 2019 I waited patiently as the pharmacy did not have Actavis in stock and had to be ordered. Over the weekend I pick up my sons meds, I checked the label on the bottle and inserts we are given… they state Actavis (my mistake was not to open the bottle to check the actual pill) I leave the store and this morning that my son needed his new prescription he opens the bottle and it is not Actavis! The label states actavis but after my research its Teva.
Can u clarify for me… what changes, if any should I be aware of between Teva and Actavis? I see Teva has bought Actavis, but is it still the exact same thing just a name change sort of say? Will Actavis still be available?
Thank you so so so much for being a great advocate and researcher for us!
Hi Maribel,
Thanks for the kind words of encouragement.
I’m sorry that you’ve been dealing with this mess. It’s so wrong. Morally wrong. Ethically wrong. Legally wrong. All kinds of wrong! 🙂
Here is the short answer: If the medication says “Alza” on it and it looks like this, you have the right pill——the “authorized generic” for Concerta.
Yes, Teva is no longer the distributor of the authorized generic Concerta.
Here’s the deal: The distributor of the authorized generic Concerta (the brand SOLD AS A GENERIC) is always changing. Deals are made. Deals expire. New deals are made.
First it was Watson, then Actavis, then Actavis was purchased by Teva, and now there is the latest distributor, Patriot Pharmaceuticals. Patriot is a subsidiary of Janssen, the manufacturer of Concerta.
Unfortunately, pharmacies today have a huge profit motive. And they make more on the cheaper generics. So too many pharmacies try to steer customers to those.
Also, they have set up their supply lines to include only their preferences for the various medications. When we ask them to fill a prescription with a medication that they don’t have in regular supply or order, they balk, resist, refuse, stonewall, gaslight, etc. They claim not to know what is an “authorized generic” (and in some cases I believe they don’t!). They don’t know what OROS means (the unique delivery system used by Concerta and manufactured by a company called Alza).
But sometimes, the good ones, anyway, they come through and do as they are supposed to: fill the script as the prescriber has written!
If at all possible, try a Walgreen’s pharmacy. They have been the most cooperative for years. CVS has been the very, very worst.
If you are using a home-delivery pharmacy, try to establish contact with one senior customer representative, one you can call upon if you hit snags. (Rather than having to wage the battle all over again with a new representative.)
Talk with your prescriber about how to make it very clear on the script, perhaps “authorized generic with Alza OROS capsule ONLY.”
You might add, “Distributed by Patriot Pharmaceuticals.” But that’s a lot to write on a script!
The particulars will depend on your pharmacy benefit company, so you will want to check with them as well.
I hope this helps!
Good luck!
g
Thanks so much for this information. Our son was just prescribed Concerta and our insurance will only cover generics. I found this page while researching Concerta generics and the pharmacy that services our plan was initially going to provide the AvKARE version. They initially told me they only filled prescriptions with AvKARE, but when I came back at them with the specific NDC I was looking for, they admitted they did have the Actavis/Teva, and that they’d provide that for us. So fingers crossed. I’m sure you won’t be surprised to learn that the first ADHD med they prescribed was Adderall – it was an utter disaster. Wish I’d found you sooner.
Hi John, I’m glad you found me, too!
The thing is, the authorized generic IS a generic! Your physician should be able to specify WHICH generic (that is, Teva/Actavis).
Good luck!
That’s right. Don’t let your son go backward!
Print and bring to them, if you think that will be helpful.
Some medical professionals look askance at “something I read on the Internet.” 🙂
This article is very helpful after my son complained his Concerta (Trigen) weren’t working. I wanted to ask if you know anything about Avkare manufacturer as my other son received that and I’m now wondering if his recent episodes his to do with the manufacturer switch. He is also on different meds so I’m not sure if it’s the Avkare or a different one or a combo etc. I am waiting on a a call from Dr at this point but wanted to ask since I can’t find anything like this article online about Avkare.
Thanks!
Hi Andrea,
Yes, Avkare is a Tennessee-based distributor of the Concerta generic made by Amneal.
I mentioned this generic in the post: Update 6/20/18: This spring, another company (Amneal) introduced a generic Concerta.
As I explain in the post, none of these generics are using the proprietary technology that gives Concerta its unique release profile. It’s called OROS.
Good luck!
g
Oh Thanks, I didn’t realize Amneal was the same as Avkare, thank you for clarifying. Still waiting on Dr after convos with nurse back and forth but will hopefully switch back since he has done so great for a longtime and we don’t want him to go backwards again. Thanks again for this article!
I called around today looking for a non crappy generic Concerta. Cvs and Walgreens were both refusing to tell me over the phone what generics they carried making a variety of stupid excuses.
I called a smaller pharmacy and explained I was looking for Concerta Generics that have “Anza” on the pill. He looked in his system and found three manufacturers that had that label on the pill itself (the system had pictures):
-Activan/Teva
-Patriot (a wholly owned Janssen company)
-American Health
Another generic was also available that was confirmed to NOT have Alza printed on it was from a manufacture named “Lannett”.
Hope this helps.
Hi Josie,
Thanks for the report.
Yes, pharmacies typically will not say over the phone if they have a certain stimulant in stock.
The justification is fear of being robbed for it. Is this fear justified? I have no idea. Perhaps in some stores.
Actavis/Teva is the official distributor of Concerta’s authorized generic.
American Health is a specialty packager of medications. It takes the pills from Actavis/Teva and puts them into blister packaging:
American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Actavis Pharma. as follows: (18 mg / 30 UD) NDC 68084-890-25 packaged from NDC …
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=15b53374-8d97-496b-9561-1f4f3568926b&audience=consumer
I’m not sure about Patriot, other than it being a distributor of authorized generics. Typically, the marketing deal is between the manufacturer and one distributor.
https://www.patriotpharmaceuticals.com/patriotpharmaceuticals/about.html
best,
g
I switched from the brand to generic (mylan) and it had much weaker effect, but I endured it, switched back to concerta as insurance now covers it and it does feel much better.
I’m glad your story ended well! Thanks for writing.
g
Gina,
I think what your doing is really important work. I stumbled across you blog website looking for information about why my son’s medication generic methylphenidate by Actavis was switched to Concerta by Janssen, by the direction of his health insurance. I feel so angry that money is the driver and my son is forced to take a medication that doesn’t help him!
The information you provide here is priceless to me. You have given me a ton information so I can continue to advocate for my son.
Thank you.
Hope
Hi Hope,
Please read the post again. You are laboring under a misunderstanding.
You have nothing to be angry about.
Actavis Concerta and Janssen Concerta are the SAME! Not just “bioequivalent” but the same exact medication made in the same factory under the same FDA standards. The only difference is how they are marketed.
If you have ADHD as well, you want to be sure that your medication is in effect before you seek answers to complicated-sounding questions. It’s difficult for everyone but for untreated ADHD, it can be very hard.
Good luck
g
I am SO GLAD to have come across this blog, I can’t tell you how helpful your information has been. My son’s whole third grade year has been a roller coaster and I feel like a pawn in a twisted pharmaceutical company/pharmacy/insurance company nightmare! You have helped me become much more educated and I feel validated just in that I KNOW my son has reacted differently to the non-Actavis brand and they all made me think I’m crazy! My doctor is on our side, though, and was the first one to clue me in that they are NOT the same. And after I got past the horrid shock that drug companies and pharmacies would have the nerve to just do what they please for a profit, at the expense of my child’s well being, I’m ready now and we will be following the steps to get the brand Concerta. I’m hopeful this will be the answer we have been looking for.
Thank you again for taking the time to educate others, it’s so important. I appreciate you!
Hi Mindy,
I’m so glad you found my blog, too. Your son….all of third grade. That makes me want to cry.
If it’s any consolation, for all of our healthcare challenges in the U.S., everything about ADHD is worse everywhere else! Including the types of medications available.
It might behoove you to try a few alternatives in the MPH for your son, perhaps Quillivant, Quillichew, Aptensio XR, and Daytrana (the patch, if it’s still around; many people had reactions to the adhesive, as with all patch-delivered Rx).
The newer ones will offer savings programs, if cost is an issue.
If Teva/Janssen would disclose how long this marketing deal will last, we might not have to worry about alternatives. But until that happens, it’s up in the air. That is historically unusual. But companies these days have gotten the message they can do anything they want, it seems.
g
Just so you are aware. My daughter in 4th grade(13 now) was taking the good generic from from Actavis and when we got the branded – she freaked out. They looked exactly the same – same color – same size pill – the only difference was Alza was written on side instead of middle. This is not a placebo effect. Neither me nor my daughter knew the prescription was different but her reactions to the medication were out of control. So in this situation – the generic Alza worked better than branded Concerta.
Hi Lisa,
I’m afraid that is impossible. The authorized generic IS the brand. That’s what an authorized generic is.
There is no “generic Alza.”
You might want to re-read my post.
I know it’s complex, but it’s important to understand the facts.
best,
g
Our local pharmacy recently filled my son’s prescription for methylphenidate 36 with white oblong tablets marked only “M 36”. The bottle identified the maker as “ACTVA”. My research tells me these are actually Mallinckrodt tablets. Now what do we do? Is this violating a law?
Hi Wes,
So your pill looks like this?
https://adhdrollercoaster.org/wp-content/uploads/2013/08/mallinck.jpg
That definitely is the Mallinckrodt tablet.
I have heard no updates about the FDA downgrading of this generic. When it happened (thanks in large part to this blog and its readers), it was definitely NOT ALLOWED to substitute this for Concerta.
Mallinckrodt threatened to sue the FDA but I have not heard more about it.
Here is what I wrote in 2016 and I suspect it’s not out of date.
Click on the link from which this is excerpted and scroll down to Question 12, where you can download the FDA report: https://adhdrollercoaster.org/adhd-news-and-research/consumer-qa-on-concerta-and-generics/
Q 12. Argh! My pharmacy is still substituting the downgraded generics for my Concerta prescription? Isn’t that illegal? What can I do?
Despite the FDA’s ruling, some pharmacies have persisted in foisting the downgraded generics on unsuspecting consumers.
Good luck!
Gina
I am a Veteran and I have always received the Long Gray pills when I pick them up at the VA Pharmacy Window. This month they accidentally sent my Rx through their MEDS BY MAIL program and they came from a regional distribution site. I was shocked when I saw these tiny round gray pills instead of my normal ones. Thank you for this post.!!! You have cleared up a mystery for me and I will have them take me off the MEDS BY MAIL list. I have not felt these are as consistent as my normal meds.
HI Dawn,
Yay! I’m glad you found my posts. How smart of you! 🙂
I don’t know if you save money by receiving your Meds by Mail instead of at the pharmacy.
If so, maybe you could ask the doc to specify “authorized generic/OROS/Teva” on the Rx.
best
g
Thanks but there are no CVS, Walgreens or any pharmacy that has it. I didn’t know you can mail order it for 3 month supply. Thought because it was controlled substance – you can only get 1 month at a time. I think all insurances are different as I am not able to fill more than 30 days at a time through CVS caremark. I hope someone can tell me what the problem is with the shortage of methylphenidate.
Hi Liss,
Please read the post I linked to. You will learn the facts about home-delivery.
Maybe your policy does not allow for it. Maybe you would get 60 days, not 90 days.
But it is worth your inquiring with your insurer.
g
My son was doing so well on Trigen 27mg ER but on our recent fill at the pharmacy, he was switched to Actavis. Now he is showing anger and hostility that wasn’t there at all with the other 27 mg pill. Could it be related to the manufacturer change?
Hi Kim,
What that means is that your son responds better to Trigen 27mg than to Concerta.
That is, the difference that is creating problems for other people (those who do best on Concerta) actually might work better for your son.
If you prefer the Trigen generic of Concerta, ask your son’s prescriber to specify that on the prescription.
That still doesn’t mean that Trigen’s is an acceptable generic for Concerta, though.
I wrote about that issue in the blog post:
Chiefly, you should know that not one of these three generics uses the patented OROS delivery system that is central to Concerta’s delivery system. (You’ll know it’s the same OROS technology if it says “Alza” on the pill.)
As a result, many people will find the generic doesn’t work as well as the brand. Yes, some people might actually prefer the generic. It all depends on the individual. If brand Concerta works well for you or your child, however, and you don’t want to risk going off the rails, you might want to stick with the brand, whether sold as brand or the authorized generic (brand marketed as a generic).
Right now there is no Concrete of any kind available in my area. No generics at all. They say it’s on backorder. What to do? Only one that works for my child.
Hi Lisa,
Did you try other pharmacies, such as Walgreen’s?
Some profit-focused pharmacies don’t keep Concerta in stock because the profit margins aren’t as high.
I’d complain to the manager.
Also: I will repeat the advice I repeat often: If you have a home-delivery option, use it.
It’s much easier (typically) to do that four times a year (most are 90-days) than the local procurement 12 times a year.
https://adhdrollercoaster.org/tools-and-strategies/stimulant-prescriptions-via-mail-order-pharmacy-maybe/
Thank you so much for all of the great information! My son has been taking ADHD meds for 2 1/2 years. And is 9 now. He switched from Concerta generic (I don’t know which one) that was not making a noticeable difference in behavior to Adderall generic ( I don’t know which one) that was causing depression, meltdowns, anger, and self harm, then back to Concerta generic. He was doing great on the Concerta generic until a few months ago. He was having trouble focusing when he got home from school. We decided to add a small afternoon dose of Concerta generic to help him get through the afternoon. Unfortunately, his frustration, meltdowns, depression, and self-harm have resurfaced.
His school social worker mentioned that not all generic brands are the same, so I’ve been researching each of the brands for effectiveness and calling each of the pharmacies in my area to see what they carry. We have been filling his prescription at Wal-Mart, and I just learned that they switched from Watson in June to Trigen. He has been taking the Trigen 36 mg ER. The change from Watson to Trigen was likely the cause of afternoon focusing issues. Wal-Mart also told me that his 5 mg afternoon tablet (not ER) is by Mallinckrodt. The 5 mg Mallinckrodt may be the cause of his meltdowns.
My questions for you are:
Walgreens does carry the Actavis for his 36 mg ER. If Actavis no longer has the contract with Alza, is the Actavis still going to be the same effectiveness with the OROS system? Wegmans also said they carry Janssen. Does Janssen also offer generic in addition to Concerta?
Also, since the afternoon 5 mg is not ER, does it matter which brand? Walgreens says they carry KVK Tech. Wegmans says they carry North star, Camber, Mallinckrodt, and Sandoz.
I’m not sure if we should drop the afternoon 5 mg once we get on the ALZA again. Advice?
Thank you so much for your help!
HI Shenelle,
You’re not alone in being confused by all this. I’m thinking I should create an illustration, to sort out the complexity.
First, we need to separate out the two kinds of generics:
1. Authorized generic (this is the brand but it is marketed as a generic)
2. “True” generic (this is a generic made by an entirely different company; the generic is supposed to be “bioequivalent” to the brand but when it comes to stimulant medications, it seldom is).
The Concerta authorized generic (that is, the BRAND marketed as a generic) has been sold by several companies; hence the confusion here.
Here are the names of the Concerta brand and the companies marketing Janssen’s Concerta as an authorized generic:
1. Janssen (brand manufacturer)
2. Watson, Actavis, and Teva (companies that have a marketing deal with Janssen to sell the brand as an authorized generic).
Here are the names of the companies that manufacturer a “true generic” for Concerta:
1. Trigen Laboratories
2. Mylan (of Epi-Pen infamy)
3. Impax Laboratories
4. Amneal
5. Mallinckrodt (you said a pharmacist told you it was available; the FDA told Mallinckrodt to stop selling that downgraded generic)
You write that Walgreen’s does carry the Actavis Concerta but you are not sure it is the brand, with the OROS delivery system. It’s best to ignore the names of these companies (e.g. Actavis, Teva, etc.) because the names change, they are purchased by another company, etc. For now, Teva has the contract to market the authorized generic for Concerta.
The easiest way to know is to ask the pharmacist. The pill should say ALZA on it. That means it is the brand (or authorized generic marketed as a brand).
re: the afternoon…I could be confused but I thought you wrote that the Concerta generic in the afternoon resulted in frustration, meltdowns, depression, etc.
It might work better if you could get a second dose of Concerta in the afternoon. It is worth a try, perhaps on a weekend night if it does interfere with his sleep.
The fact is, his ADHD needs treatment at home, too, not just during school hours.
I hope this clarifies.
Good luck!
g
I have had a TERRIBLE time with generics for psychiatric drugs. I’d previously taken Adderall IR before Shire lost their patent, as I tend to not do well on XR amphetamines and hadn’t tried methylphenidate then. Once Adderall IR became all-generic, bam–previously unforeseen side effects like drowsiness, irritability, heartburn, and lack of efficacy for ADHD symptoms. Generic Adderall XR, generic Ritalin, generic Concerta, generic Ritalin LA, generic Dextroamphetamine IR–all awful. And my pharmacy literally refused to provide the brand names of all of these, saying “it’s all the same thing” and that the only brand name ADHD drug they had was Vyvanse (which gave me GI symptoms like brand Adderall XR did). They told me that going to another pharmacy constituted “pharmacy shopping” and was a sign of drug abuse!
My doctor had to call numerous pharmacies trying to find one that could order brand name for anything other than the brands that didn’t work (Adderall XR and Vyvanse). I tried both brand Concerta and brand dextroamphetamine IR (Zenzedi) and wow, what a difference! But he says I can’t take both because you can’t take a methylphenidate XR with an IR amphetamine booster (and I am a fast metabolizer). So now I have to choose between brand Concerta with the generic IR Ritalin (which made me so tired), brand Zenzedi three to four times a day (pricey), or try Dextroamphetamine spansules (which only come in generic now) with one or two Zenzedi boosters.
Anyone know why it’s so hard to get brand name drugs from pharmacies, who look at you like you’re making stuff up when you tell them of how they don’t work the same, even when your doctor agrees with you? In fact, my doctor agrees to the point that on his zolpidem prescriptions for insomniacs he writes “Brand name only”, and told me that the most commonly dispensed generic is so ineffectual that there are hundreds of posters on med boards talking about it!
Dear NoGenerics,
I hear you!
My understanding is that it’s hard to get brand-name drugs from pharmacies for one reason: profit. The generics are more profitable.
Yet, also, insurance companies tend to push policy holders toward the cheaper generics. It all depends on your policy, though. Some do allow for brand, but at a higher fee (sometimes a bit higher and sometimes a lot higher). Again, depends on the terms of your policy.
I don’t understand your question.
I tried both brand Concerta and brand dextroamphetamine IR (Zenzedi) and wow, what a difference! But he says I can’t take both because you can’t take a methylphenidate XR with an IR amphetamine booster (and I am a fast metabolizer). So now I have to choose between brand Concerta with the generic IR Ritalin (which made me so tired), brand Zenzedi three to four times a day (pricey), or try Dextroamphetamine spansules (which only come in generic now) with one or two Zenzedi boosters.
I find it problematic that MDs think in terms of “booster” instead of “coverage throughout the day and perhaps into the night”. In other words, why can’t you have two doses of Concerta, the second taking as the first is wearing off. Most people don’t get the full range that these extended-release medications list in the marketing material. Some people do, and some people feel the effects for longer. But some much shorter…including, as you say, rapid metabolizers.
Also, there’s no law that says you cannot mix the stimulant classes (amphetamine and methylphenidate). Perhaps you could try it and see how it goes.
Even if you stick within the same stimulant class, the “booster” IR Rx can be so different than the ER/IR that it might as well be a different class stimulant.
The doc should be working with you, to help with your priorities. IF avoiding the generics are the top priority, he should start from that premise.
With the newer products, such as Zenzendi, there is often a cost-savings program. You might want to check to see if you qualify. http://zenzedi.com/
Best,
Gina
Sorry if I missed this in the comments, I tried to read through them all but there are a lot!!
My daughter is one of the rare ones who did better on the Mylan generic. When that was going away she was switched to Jannsen and we noticed a significant decline. We actually were able to go back to Mylan for 1 more month (all the pharmacy had left) and saw a return to desirable results. I was shocked after research showed the pill we preferred was not the authorized generic.
Now that Mylan appears to be gone for good (it’s not listed as a product on their website) I wonder if you would recommend trying the Trigen? Are those both inferior products similar to each other? She has been on several generic forms of Metadate over the last few months and they just aren’t cutting it. Trying to get back to a place where her medication is helping her. Thank you!
Hi Jessica,
I think I addressed that in a previous post on these Concerta generics…there are so many details to keep up with!
Here is the bottom line: These generics do not perform like Concerta well enough to work for the people who do well on Concerta.
THAT is the problem here. The generics are supposed to perform as well as the brand.
If a person doesn’t do well on Concerta brand but does better on the generics, that’s a separate issue.
These “inferior” Concerta generics might work better than the brand/authorized-generic for some people.
It all comes down to the individual and how the release “profile” works for that individual.
If your daughter doesn’t do well on Concerta, you might want to try another choice of stimulant entirely.
But if you want to try one of the new Concerta “true’ generics, I suspect it’s the luck of the draw. Start with what is available to you. Perhaps that’s the Trigen product.
Good luck!
Gina, thank you for this blog! My daughter started taking generic Concerta about 4 months ago, and out of the 4 “generic” prescriptions, only one was marked with the authorized generic aka Alza, and it was the only one that truly worked and lasted for her. It took me a few months of observations, talking to her grandma about her observations, and ultimately this blog to figure out the round Amneal pill she was prescribed was not the same as that marked Alza – due to its different delivery method I found on this blog. Her dr claimed all generic Concerta is the same, but I will be educating him next week at her next appt. Publix must have just had some Alza in stock that month and maybe that’s how we got it that one time, I don’t know, but the last two months she received Amneal from Publix…which doesn’t last as long. So I spoke to a Walgreens pharmacist today, and she concurred with what you wrote, to have the dr write out like you stated above “Concerta Authorized Generic/Teva NDC#….”. She added that it must also state “Medically Necessary “ on the prescription, then she said it will take a week to get it in. I certainly hope this works!! Will let you know. Btw we are in Orlando. I also went to Publix and spoke to a pharmacist asking if they could order the authorized generic Alza marked pill, if the prescription was written exactly as the Walgreens pharmacist advised, and the Publix pharmacist said no, that they have to accept whatever they receive from the supplier. Thank you for leading me to Walgreens. Didn’t waste my time going to CVS.
HI JC,
Thanks for sharing your comment. It’s crazy, isn’t it?
Think about what that Publix pharmacist said, according to you: “Our profits are the only consideration. You get what we give you.”
How is that even legal? Perhaps the rules vary by state.
I suppose you know which store should get your shopping dollars from now on.
Good luck!
Hello! Promised I would send an update. My daughter’s psychiatrist was completely understanding when I asked him to write out her prescription, specifically asking for the “authorized” Concerta generic brand. He said other patients are also complaining that the newer generics aren’t working as well for them either, but he also said I am the only one who asked for the prescription to be written out as you specified in your blog, and he didn’t know what the “NDC” stood for, but he said it was worth a try and curious if it would work. He added this to the prescription: “Concerta Authorized Generic/Teva, NDC# 00591-2718-30 Medically Necessary”. This is for the 54 mg, FYI. I took it to Walgreens (they told me it had to say “medically necessary), they knew exactly what it meant, said because it specified a certain manufacturer, they could only fill it with that specified pill (yes!!), and within 2 days the prescription was filled, the supplier had it on hand. I had to wait until today to pick it up, due to the 30-day rule, but now have it in my hands, the elongated pills with Alza imprinted on them. Can’t believe it worked!! I never would have known how to get the authorized generic if it wasn’t for this blog. Hoping next month will work out the same! Thanks for helping my 10-year-old daughter get the correct medication, although, it should not be this difficult, should it be?
Hi JOC,
Wow, great news! I’m so glad you found my blog!
And no, it shouldn’t be this difficult. And no, I shouldn’t have to drop whatever else I’m doing and lobby the FDA to downgrade crappy generics, warn consumers, instruct on the details, etc. But there ya go. 😉
g
Hi All. I found authorized generis with OROS delivery marked Alza at Walgreens! My insurance stopped covering Concerta so I had to find a generic. We tried several that were in a normal ER pill form and they did not last 12 hours like Concerta does. I called Janssen and they confirmed that Teva is the authorized generic. I could not find that, but I did find some Activis manufactured generic at Walgreens and it is in the OROS pill and says “Alza 18”. I got that at Walgreens. I live in SC. I called Publix and CVS and they did not have Teva or Activis. I hope this helps someone!
Good for you! You didn’t need to call Janssen. It’s all in this post. 🙂 Maybe you called Janssen before you found this post.
You should also be able to simply say “Concerta authorized generic”.
Alas, too many people writing and filling prescriptions do not know the difference between “authorized generic” and “too generic.” That’s why I have to educate on my blog.
The manufacturer should not matter, and it’s confusing because it is changing all the time.
In fact, neither Actavis (previous) or Teva (current) manufacture the Concerta authorized generic.
Rather, they distribute it. The authorized generic IS the brand, marketed as a generic. It is made by Janssen.
CVS typically does not carry this authorized generic because it apparently does not fit with their profit model.
Walgreen’s typically does carry it.
EXACTLY. Fighting with insurance b/c I finally found a local independent pharmacy that can/will order the OROS Teva/Actavis but Fidelis Healthy Children insurance reimbursement for the “Authorized” generic falls short $41.88 and the plan *requires* a FDA approved generic be used–Trigen, Mallinckrodt, Mylan, etc. I hate to say it but THANKS T for the repeal of the pharmacist gag order on pricing. Trigen is the low cost drug so that’s why the market is flooded with it. Found and filed forms with my Dr. to cover the Auth Generic or Name Brand. One denial under my belt b/c after getting signatures from Dr they mailed it back to me. I was told I need to submit it. No charts, no notes, just the signed form. Fax it in….. DENIED for lack of records. Got a call from the Dr.s’s Prior Auth department a few days later they received the denial they were told it was b/c the Trigen was working…??? WTF? and the Dr.s’s office asked why on earth did I submit that; it was their job to submit and now we have one strike and only one chance to overturn. ugggggghhhhhh! The only good news is the OROS patent is good for maybe 2 more years if my research is right.
Arg. I’m sorry you are dealing with this, KH.
I worked so hard (and many people did their part in filing MedWatch complaints after I opened the case) to get the first two inferior generics downgraded.
We barely had a minute to celebrate before four more inferior generics lowered the boom on us.
Unfortunately, this is the nature of patents and generics. And it’s also the nature of profit-seeking pharmacies putting the squeeze to patients and insurers cutting costs (depends on the policy, of course, with some better than others in this regard).
I hope that if you can find the Concerta, you can find a new substitute. There are several new stimulants.
g
I am a child psychiatrist practing in North Carolina. I have been incredibly frustrated with being told the Trigen generic is the same as the Teva/Actavis generic. I did some research and it does seem that Trigen is an “OROS” technology. It is under the trademarked Osmodex system. So it is a “OROS” mechanism but that does not mean it is exactly like Alza. I guess what I am trying to say is that I have found no release profile curves which compare the rates of the two mechanisms. Here are some links below, maybe someone else might be able to take this information and put it together better.
https://www.sec.gov/Archives/edgar/data/1739426/000104746918006732/a2236928zs-1a.htm
http://www.earthjournals.in/crps_171.pdf
I have some patients who can tolerate the Trigen but many more who cannot. Good luck all!
Hi Anne-Marie,
Thanks for your comment—and for keeping a watch on this issue for your patients.
To be clear, as I pointed out several times in the post, OROS is the patented Alza technology.
There are other “osmotic” systems but the only OROS is Alza’s.
Also, as I mentioned, the problem is not that the Trigen generic is “bad.” It is that it doesn’t have the same release profile as Concerta, presumably because it uses a different type of osmotic release.
Also as I wrote, some people might not do well on Concerta but will do well on the Trigen generic (and some people are less sensitive and might do well on either). But they essentially are two different drugs, given the different delivery systems.
thanks,
Gina
By the way. Great site.
I’m a materials science engineer and a registered civil engineer in Calif. I’ve been taking Concerta ever since it first came out. And switched to the “generic” when first available. These three new generics are definitely not generic Concerta. Concerta is the ALZA OROS delivery system for methylphenidate as far as I’m concerned.
I doubt the three new manufacturers are using anything remotely like the ALZA OROS system. It may be osmosis, and maybe (but much more questionable and more likely the manufacturers are lying about this part) that they are using something to push the medicine out; but, it’s not an ALZA OROS delivery system.
When Concerta first came out I cut a real, original (no generics yet) tablet in half, with a wire diamond saw, and examined the system using a stereomicroscope and a polarized light microscope. The outside of the tablet has a quick dissolving layer of medicine for immediate release; wet your fingers. Under that layer is the tablet’s synthetic osmotic membrane that allows liquid into the tablet. At one end of the tablet (approximately 1/3 of the tablet length) is a finely chopped/diced, compressed material, sort of greenish, that I’m pretty sure is simply processed seaweed–looks like the “irish moss” I use for fining my home brew. The rest of the tablet has the medicine matrix. And a laser drilled micro-hole at that end. There is nothing between the two materials, like something that would “push” the medicine through the pinhole at the end. I think the seaweed material simply expands and pushes the medicine, as it dissolves in the liquid entering the tablet membrane, through the pinhole. It’s a simple setup from a physical standpoint. But, a small, round tablet would be a much more difficult system to setup for efficient, consistent delivery. Real Concerta’s tube/cylinder system is very simple, better delivery control geometry. I suspect the type of seaweed material, how it’s compressed, and finally how the medicine matrix is designed for dissolution over time makes the system work so well.
I just tried Amneal’s little pill (Walgreens didn’t bother to tell me there was a substantial change in my pill shape and it’s manufacturer. I found out when I got home and opened the bottle. I’m pretty sure that’s a California state requirement and probably a federal requirement, too–to notify and inform me.) and it’s just lousy at delivering the medicine consistently and uniformly. And I suspect my 36 mg pill did not contain anywhere close to 36 mg. I truly doubt the drug release profile over time is anything like a Concerta 36 mg drug release profile. FDA should check that out. The original Concerta dosages of 18, 36, and 54 mg were based on trying to come up with a dosage to duplicate taking regular Ritalin every three to five hours or so–something like that only without big surges of medicine from a 5, 10 or 20 mg pill, episodically. I’m tempted to design some simple release comparison tests. 1. I used to own a materials testing lab. 2. I ran a pharmaceutical pilot plant, manufacturing three drugs for human trials in Europe for Dow Chemical while I was going to college.
Apparently the FDA doesn’t know how to cut a tablet lengthwise. Or use a macroscope. They must listen to big pharma company minions well, ‘though. Also seems like legal agreements, to distribute pharmaceuticals to the U.S. public, should be readily available to the U.S. public. Or does the FDA think we need protection from such scary information so we don’t hurt ourselves…
Hi Kegan,
Thanks for your comment.
Wow, you have really gotten up close and personal with your Concerta!
Yes, the technology is exactly as you describe.
1. Walgreen’s has actually been the “good actor” in all this generic Concerta mess, with CVS/Caremark being the worst.
2. Pharmacists fill according to what your physician prescribes. If your physician did not prescribe the authorized generic/OROS/Actavis/Teva/Alza Concerta, I don’t think it’s the pharmacy’s fault.
Perhaps at a small independent pharmacy, a closer eye would be on regular clients’ prescriptions. But a large chain? Probably not.
3. Your criticism of the FDA is misplaced. The FDA is well aware of how these generic manufacturers are exploiting loopholes. The challenge comes in establishing generic standards for these complex delivery systems.
The FDA was very helpful in opening a MedWatch case for the first round of inferior generics, and many ADHD Roller Coaster readers followed through and reported any adverse effects.
You can do the same with the generic you received.
Cheers,
g
Amen.
Hi Gina,
Thanks for the reply. I called my pharmacist and asked if they had any Actavis branded generic Concerta. They said they had it and was able to switch the medicine for me. I now have the Alza 36 pills. After, I showed him the FDA posts regarding the Mallinckrodt and Lannett Kremers brands. I asked them to put in my file to fill with Actavis only going forward.
Good for you, Mike! Great follow through — and thinking ahead to prevent this happening again! (we hope).
Kudos!
g
Hello! I found this site while looking for more information on a concerta generic my pharmacy just filled. I was just prescribed Concerta 36mg. When I picked up the medicine, I looked at the pills and they are a pinkish capsule shaped tablet with “36” printed in dark ink. I looked these up and am now concerned. Did I just get the pills from Lannett/ Kudco that the FDA is looking into? It seemed this was going on for some time and I can’t find any more updates other than Lannett asking the FDA for more time to present data. I thought these were not in stock anywhere. Please let me know any info you have. Greatly appreciated. Thanks
Hi Mike,
I haven’t heard the latest. But yes, it’s possible that you received one of the FDA-downgraded generics. It’s also possible you received yet another new Concerta generic (a joint effort from Andor and Lannett).
Do you have a photo?
Background:
Lannett purchased Kudco, apparently around the time of the downgrade:
https://www.forbes.com/sites/nathanvardi/2016/10/17/shares-of-lannett-tumble-after-fda-moves-to-withdraw-approval-of-generic-adhd-drug/#17fed56f72d6
Looks like they are giving up on the downgraded generic and have lighted upon another one.
Here’s what I wrote in another comment:
The Kremers-Urban generic for Concerta was downgraded by the FDA several years ago. Because it was found not as effective as Concerta, it could no longer be substituted for brand. Without that status, there might not be enough market for it and so it’s no longer available.
The FDA asked for the two generic manufacturers (Kremers-Urban and Mallinckrodt) to voluntarily remove their downgraded generics. Mallinckrodt filed suit against the FDA, but I think that suit was tossed out by a Maryland judge. I thought Kremers-Urban had agreed to withdraw the product. Perhaps they did so after all supply was distributed and sold.
Here is where I learned about Lannett’s new (?) Concerta generic from Andor (?), pending ANDA (August 3, 2018):
Lannett Company (NYSEMKT:LCI) has entered into an exclusive perpetual licensing agreement with Andor Pharmaceuticals for Methylphenidate Hydrochloride Extended Release (ER) tablets USP (CII) in 18, 27, 36 and 54 mg strengths. Andor’s pending ANDA of Methylphenidate is expected to be approved as an AB-rated generic equivalent to the brand Concerta.
Under the agreement, Lannett will primarily provide sales, marketing and distribution support of Andor’s Methylphenidate ER product, for which it will receive a percentage of the net profits.
And here: https://www.drugstorenews.com/pharmacy/lannett-and-andor-partner-to-launch-methylphenidate-hydrochloride-er-tablets/
To be truthful I have not read through all these comments, but in addition to a lot of confusion there seems to be a LOT of problems with pharmacies. For what it’s worth, I just wanted to share that I have used the Costco pharmacy in WA for 5+ years and have had ZERO problems. They have noted my ‘preferred generic brand’ for my grandson’s Concerta prescription, and have at times gone to the extra trouble of ordering that brand if they don’t have it in stock. I have DSHS insurance (through the state of WA) for my grandson, so I definitely don’t have a lot of choices on where to go.
I’ve seen a lot of criticism of CVS (and other pharmacies), so I just wanted to give a very positive comment for Costco. can’t seem to attach a picture, but the pills look like the capsule-looking white pills another reader posted and shows ALZA.
Hi Carol,
Thanks for weighing in. I’m glad you have found Costco helpful. I’ve checked and found Costco doesn’t offer Schedule II medications via home-delivery. And I never checked further.
Yes, if your pills say Alza, they are the brand/authorized-generic.
Thanks!
Hi Gina,
It’s good to read this page and find out that there are several other individuals/families who have had similar experiences with these new less effective generic Concerta capsules.
As far as the Teva/Actavis generic, I called Teva customer service and they suggested that my psychiatrist actually write the NDC# (National Drug Code) on the prescription, in addition to “Teva/Actavis authorized generic.” That way there really is no way that the pharmacist can substitute another generic and say it is “equivalent” to the OROS delivery system.
I sent the script to my mail order pharmacy, Aetna Rx, and they were able to get me the “authorized” generic Teva/Actavis pills. The actual NDC #s can be found on this Teva website:
https://www.tevagenerics.com/product/methylphenidate-hydrochloride-extended-release-tablets-usp-cii
Hopefully, this information is helpful to others. It will be a real let down if Teva stops manufacturing this authorized generic.
Hi Roger!!!
This is great info, thanks! I am printing that web page for future scripts, although Walgreens have had no problem with the manufacturer’s name only on the prescription. Our Walgreens pharmacist told us that TEVA/Actavis is their default manufacturer for the Concerta generic, that is why it is so much easier to find them there than at other retailers.
Dear Roger,
Thanks so much for taking the time to share that useful info!
I will add it to the post.
FYI- Teva doesn’t manufacture the authorized generic. Teva markets brand Concerta as an authorized generic; Janssen is still the manufacturer. The terms of this marketing deal remain not a matter of public consumption, unlike in the past. So we don’t know how long this will last.
Gina
I have been running around to every pharmacy in town this week trying to get my Actavis Concerta. Walgreens stocks the Amaneal (sp?) brand now, but the pharmacist said she can order Actavis. Now I just have to go unmedicated for 4 days while I wait. I think Walmart told my husband they could order it, too. CVS is as worthless as the generics themselves. >:(
HI Einn,
I’m glad your Walgreen’s pharmacy is helping you. But four days….oy.
CVS is deplorable. Seriously, it should be illegal the stunts CVS pulls.
Good luck,
g
Ah, of thanks.
I posted earlier, she is and has been taking an anxiety med. Sorry if it got lost in the flurry of new comments lately. xo
Hi Kristen,
Yes, I read that. I was referring to maybe re-examining the choice/dosage/timing of that anxiety Rx.
It could be that improving that would help with the appetite suppression.
g
Thanks Miriam! So many great suggestions there! I saw your summer camp post and really felt for you. This is some tough stuff for all of us to navigate–it makes me so mad that you/I/all of us have a med that works but the profits make all the difference. I’ve had some interesting conversations with pharmacists over the last few days now that their “gag order” is off. But in response to your helpful comment, we made the change to whole milk and do our best with breakfast but lunch is a compromise (we need calories in her and can’t directly supervise so it’s nothing to be proud of, but it gets her eating) and then a light dinner, dessert, second dinner (after the meds really wear off she’s ready to eat again before bed). Tricky stuff for sure.
Hi Kristen,
It might be worth revisiting the anxiety Rx.
g
Thanks she is taking a low dose of anxiety meds too, but the stimulants did kill her appetite. When she started she wasn’t chubby per se, but was a sturdy little girl. Now she’s very lean, but stable and putting on weight as she grows. Dr. is keeping an eye to make sure she keeps gaining. Regarding the script, it must vary by state b/c my pharmacist (NY) says it doesn’t matter how the script is written, the wholesalers who stock the pharmacies refuse to carry it and the pharmacist must get it through a wholesaler–they cannot order directly from Actavis/Teva and cannot force the wholesaler to order it. *That goodness for the lifting of the gag order on pharmacists to talk $*. A different pharmacist I spoke to today said the insurance company sets a price at which they will pay for generic Concerta, he’ll order it but it’s more expensive than the other generics and I’ll have to pay out of pocket if the reimbursement rate doesn’t allow him to at least break even.
Hi Kristen,
Ach. I’m sorry this is so hard for you.
I wonder if you should get a second opinion — and call the insurer. Maybe you’ve already done that.
If you financially qualify, Janssen has a patient-assistance program. Could make everything so much easier.
https://www.janssen.com/us/patient-resources/patient-assistance
Good luck!
g
Hi Kristen,
I really feel for you and your family. We went through similar struggles when our mail in pharmacy (Caremark) decided to switch from Actavis to Trigen without telling us during the summer. It made summer camp hell for my son and our family. He became very aggressive and non-compliant. We were so scared about the start of kinder, but since we started filling the prescriptions at Walgreens specifying Actavis/TEVA only, we have not heard a peep about his behavior from school, after school care or enrichment activities. He is so much happier too.
Regarding loss of appetite… we went through something similar with our oldest. We talked to a nutritionist that gave us very good ideas on how to pack calories and all the nutritents she needs in the meals not affected by the medication, like breakfast. Things like making shakes for her with fruit, Nutella, cereal… We also switched her to whole milk. Those things have worked out really well. So, perhaps a nutritionist may help your daughter too.
I filed a report today for the 18 and 27 mg Trigen (DD takes both to make a 45 mg dose)–accepting defeat that I cannot find/get Actavis anymore I switched DD over in July. It seemed to be working (and, yay, her appetite returned and she no longer needed melatonin to sleep). But now that we are a month into the school year its all too clear it’s not. Today I substituted an Actavis 27 mg I had left over for the Trigen and DD said it was an amazing difference–she could focus! And the old side effect of no appetite returned as well. Back on the roller coaster–but I found a pharmacist who told me he can order the Watson (Alza) pills. I was a little surprised as Watson is no longer the marketing arm for it, but if he can get it, great. The bad news, he won’t get it if my insurance won’t cover the cost (it’s more expensive than the others) and I can’t make up the difference in cash as it would violate his contract with the insurance co. both pills would be about $500 out of pocket. ugh. This is crazy.
Hi Kristen,
I could have sworn I wrote a reply to your other comment on this topic, but it’s not here!
It doesn’t matter what you call the authorized generic (Teva, Actavis, Watson…..the names change frequently and is just the seller; has nothing to do with the medication itself), as long as you call it the authorized generic with Alza OROS technology. . Maybe it varies by state, but my understanding is that the pharmacy has to fill what the prescriber stipulates. Have you tried that?
As for the appetite suppression, that could be signaling the presence of anxiety. Most people with ADHD will have at least one co-existing condition; half will have TWO. For that reason, it seems that most folks with ADHD on medication will do best on two medications. One for ADHD and one for anxiety/depression,etc.
It is a shame how many people are suffering side effects from stimulants precisely because physicians fail to treat the full range of symptoms. Instead, they just stop and try another stimulant. It’s crazy.
I would ask your physician to evaluate your daughter for signs of anxiety as well as ADHD.
g
I agree with you regarding the OROS technology. I’ve tried to reason with a couple patients that pay hundreds of dollars every month when I will (while I still can) order the Activas. The article states that it is a percentage of the dose. For your diligence and time as an author and a blog writer you should read the article. I agree with you on this account, but the article creates a misperception on other medications and creates a gross negative perception of generics. Generics save the patients money and reduce premiums for all. I run into this with Adderall XR also. I will gladly order the Sandoz, but “it doesn’t work” and that is the problem we see and leads to higher health care costs for all.
I’ll read the article when you read my two books and 10 years of blog posts. 🙂
I am busy, and most of the work I do is pro bono.
Generics are still risky business for people with ADHD and others who take psychotropic medications. I always encourage that they try them, to see if they work, but to try the brand first, so they have a comparison.
I actually do know this territory, from helping 1,000s of people.
The major reason we have “higher health costs for all” is due to much more significant factors than brand medications.
g
Funny that today several new entries came in on this blog. I commented earlier that we made the switch to Trigen over the summer and luckily no problems. Well I’ve noticed that my DD (who takes an 18 and 27 mg) seems a bit hyper at the end of the day and her eyes are all over the place but her appetite is back and she’s sleeping better so crossed my fingers and hoped that the Trigen was working during the day. Going to get her script today after school and she says, I think I need a higher dose I can’t focus in school. I really HATE that CVS or ANY pharmacy (even Walgreens) won’t carry the Avantis/Teva anymore or that the NYS Healthy Child has no online pharmacy benefit–not that it would matter they use Caremark (CVS). This is complete BS that the auth. generic is available but PROFITS dictate that my DD can’t get the OROS. Now here we are in the MIDDLE of a school year and we’ll have to search for a new drug.
That stinks, Kristen.
Walgreen’s has typically come through for folks. I wonder why your store won’t.
I’m pretty sure that if the physician stipulates Actavis/Teva authorized generic, the pharmacy has to fill it.
It might take a while, though.
g
I agree there are patients that have had different results with other generics than Actavis. However, you’re a little misleading on the 80%-125% explanation. That’s much different that 10% of branded drug. While there are agreeable differences in small therapeutic index meds such as seizure meds, transplant drugs, hormones, and Concerta it should be known how small the difference actually is. This link from the FDA explains it more clearly: https://www.fda.gov/downloads/drugs/guidances/ucm070244.pdf
Hi Chris,
Thanks for your comment.
Just to be clear: Patients have had “different results with other generics than Actavis” because Actavis is an authorized generic. That means it IS the brand; it’s only marketed as a generic. The other generics are so-called “true” generics; that is, generics in the way that most of us think of the word: a drug that is similar to but not exactly the brand.
I’m sorry but I don’t have time to wade through that FDA document. I’ve read quite a bit on this topic, and I know that it’s not simple. The percentage refers to a confidence interval, etc.
For example, this PharmD writer takes issue with this piece in Pharmacy Times: Debunking a Common Pharmacy Myth: The 80-125% Bioequivalence Rule
Is he accurate in his finer points? I am not sure. Because he is a pharmacist who works in the insurance industry and as for-profit pharmacy store, it’s possible that his perspective is biased.
More importantly, when it comes to the true generics for Concerta, the chief problem involves the release profile. As I’ve written many times, the OROS technology gives Concerta its unique profile. Without it, it’s just another type of methylphenidate product.
It is modern delivery systems that are vexing the FDA in terms of establishing generic guidelines.
This is a useful paper, I think, excerpted:
That is, for in vivo (in vitro), a test drug product is said to be bioequivalent to a reference drug product if the estimated 90% confidence interval for the ratio of geometric means of the primary PK parameters (AUC and Cmax) is totally within the bioequivalence limits of 80% to 125% (90% to 111%). The one size-fits-all criterion does not take into consideration the therapeutic window and intra-subject variability of a drug which have been identified to have non-negligible impact on the safety and efficacy of generic drug products as compared to the innovative drug products.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4157693/
Cheers,
Gina
I am a physician. My 14 year old patient is getting Trigen 36 taking two each morning. I just found out that they have received this generic now for several months and they have not noted any problems.
Hi Charles,
I’m confused. Who is “they” (in “they have received this generic now”)?
Do you mean your client and the client’s parents?
The issue isn’t a problem with the medication itself. The issue is that it is not “bioequivalent” enough to be considered a true generic for Concerta. Some people might find that the generics work better for them than the brand. But that simply reflects their own need, not how well the generic matches the brand.
Did your patient take the brand Concerta at 36 mg prior to taking the Trigen at 36 mg?
Thanks,
Gina
Hi Gina,
I so concur with the other readers, you have been a life saver for my family!
My son was diagnosed with ADHD at the end of last school year. We have an awesome pediatrician who looked into every possibility before we all agreed that was it.
We started a medication trial and ended up with Concerta 27 as the optimal drug for him. Everything was finally working fine, he was going to summer camp… and then, all of a sudden, we started getting reports from camp about extremely aggressive behavior and disobedience all day long. We didn’t know what had changed all of a sudden, so I started researching for problems like this online… and then I found your blog about the “fake” Concerta generics. Everything clicked.
I realized that our CVS mail in pharmacy had changed the manufacturer of my son’s meds from Actavis to Trigen. The timing of his behavioral outbursts in camp coincided to a “t” with him taking the Trigen drugs. I went to spend the day at camp with him to observe after giving him the Trigen pill… I could have just given him a glass of water and it would have been as effective as those darn pills.
We printed all the information you provided, discussed it with our pediatrician, who gave us a new prescription specifying the Teva/Actavis generic only.
By then, the camp staff have had enough and told me he had to leave. I had a meeting with the camp Director to explain what was going on and he agreed to keep him a few more days to try the Actavis pills. We were able to fill it at Walgreens, and I spent another day at camp with him. Wow! He was a completely different child, getting along with the other kids, listening to the counselors, transitioning without activities without any issues…
From that moment, life has been good, just filling the prescription at the local Walgreens (CVS mail pharmacy will just not play nice), but we are seeing red flags again.
Walgreens is running out of Teva/Actavis stock and they are telling us is back ordered. The last prescription took calls and trips to 5 different Walgreens to find one that had very limited stock. So, I am very concerned we are going to end up without the real generic very soon.
I checked the Teva Pharma website and they show they make the real generic for Concerta. So, I wanted to ask if you have any updates on Teva supplying pharmacies with the drugs or anything important on this matter.
Dear Miriam,
Thanks for the kind words. As you can imagine, I earn no income from this work but it still takes an immense amount of time I could be spending earning income.
It really helps to know that my time has made a difference for families such as yours.
People have no idea…the difference. It’s well and truly crazy.
I’ve contacted Teva but they will not disclose the arrangement they have made with Janssen (Concerta manufacturer) to market the brand as an “authorized generic.”
This is unprecedented. The deal between Actavis and Janssen were always made available publicly.
Now, it seems that few companies consider themselves accountable.
CVS….don’t get me started. It has been an extremely “bad actor” throughout this. Walgreen’s has been the best.
After spending EIGHTEEN DAYS, every day, on the phone with our new insurance company, I finally gave up. A different story each time. I had called previously to see what exactly the prescription needed to say, in order for my husband to get the authorized generic for Concerta.
Only “Twitter-shaming” the company CEO led to a response.
I don’t know the terms of your pharmacy benefit, but it SHOULD work this way:
If an authorized generic is available and the prescribing physician stipulates that the Rx be filled only with that authorized generic, the pharmacy is supposed to do it. It will probably take a while, though, as I suspect CVS/Caremark doesn’t stock it. (Our previous mail-in pharmacies, Express Scripts and PrimeMail, filled the Rx speedily and with no problem.)
You could call and ask if that is the case.
You could also try another stimulant, if your child hasn’t tried some already. Including another class (amphetamine), including Vyvanse.
Otherwise, there are other options with methylphenidate (the active ingredient in Concerta), each with their own release profile (and it’s that profile that can make all the difference).
Aptensio, Cotemplate XR, Daytrana, Quillichew, and Quillivant.
The first two are newer products and so there might be discount programs (check the company website…just search the name of the medication).
It is unconscionable, these hurdles that have been thrown at us. And with our current government administration, I am afraid it will only get worse. Consumers have no rights, and these companies have unending right to profit.
Good luck!
Hi Gina!
I wanted to provide some information that I think may be useful and hopeful. I was able to reach Teva’s customer service and got a response regarding the manufacturing status of the Concerta generic: “Methylphenidate Hydrochloride Extended-Release 18mg, 36mg and 54mg Tablets are active and available; whereas, Methylphenidate Hydrochloride Extended-Release 27mg Tablets as on backorder until mid October but this information can change. Teva is licensed to sell to wholesalers and distributors only; we do not know which pharmacies carry Teva’s product lines. You may wish to check a few other pharmacies in your area to find one that may carry our product or may agree to order our product for you“
I just filled both Concerta 27 and 54 at my local Walgreens last week. They were out of one of them but the pharmacist offered to order it on Saturday and we were able to pick it up on Wednesday. So, it looks like the true generic may be back in the market. Yeahhh!!!
Hi Miriam,
Aren’t you a sweetie! Thanks so much for contributing to the brain trust here. I am glad you seem to have gotten the medication you need!
One point to clarify: When you say the “true generic may be back in the market,” you mean the authorized generic, right?
The “true” generics are those that do NOT have the OROS technology that is central to Concerta’s release profile.
The “authorized” generic is the brand; it’s only marketed as a generic.
(It’s so confusing!)
I’ve known that Teva has been supplying some pharmacies with the true generics. What has been odd is that they have not publicly announced the deal with Janssen (Concerta’s manufacturer). Typically, these agreements are announced in the various industry news outlets. This one is being kept mum, so that means we cannot know when the agreement expires.
In most cases, the physician can specify “Actavis/Teva authorized generic” and the pharmacy will have to track down a supply. That can take longer. That means some people will give up, because they cannot go without medication.
But if you start out weeks before the medication is needed, and if you’re working with the same pharmacy over time, the routine can be established.
Thanks again!
Gina
Hi Gina,
Yes, I meant the OROS technology authorized Concerta generic. Since we read your blog we have been asking our pediatrician to write the TEVA/Actavis generic brand only on the prescriptions and Walgreens have been filling from their stock or ordering for us.
Great, Miriam. I’m glad Walgreen’s has come through for you.
I have no business relationship with Walgreen’s, and I have been very impressed with how the store has treated customers through the years of this mess.
Walgreen’s definitely put customers first and profits second.
CVS and Caremark? Abysmal.
best,
g
FYI:
Just got a new prescrip for Concerta generic 54 mg.
The bottle says ACTAVIS. Brownish white cylindrical pill
Used an internet coupon for good price at our preferred Walgreens which is not the closest one: just the easiest to deal with.
Thanks for letting us know, Dana.
Actavis IS the authorized generic (that is, the brand marketed as a generic).
Yes, Walgreen’s has definitely been the more reliable and reputable pharmacy through all this mess.
Kudos to Walgreen’s.
Gina
I’ve been getting the authorized generic from my local Walgreens for years – until today. They no longer have it at all, and instead gave me a generic manufactured by Amneal. It’s a simple white tablet (36mg) that looks like an aspirin. I’m furious. I haven’t tried it yet, so I suppose I should have hope. But regular slow-release methylphenidate has never worked well for me. I feel like the FDA keeps signing me up for a drug trial without my consent and I’m so tired of it. I’ll be interested to see what you can find out about this new generic from Amneal. Thanks for all you do to help keep us informed!
Hi Tara,
The authorized generic IS available, from Teva/Actavis.
If your physician has specified “authorized generic/OROS/Actavis only,” then that’s what the pharmacy is supposed to fill.
I hear you about the unwitting drug trials. It’s nuts. The FDA is in a bind. It was very cooperative when I queried them years ago about the now-down-graded Concerta generics.
The problem is that there are no new guidelines on how to allow generics for medications that have complex delivery systems (e.g. Concerta, Vyvanse, etc.).
With this kleptocracy currently in office, I am not holding out hope new guidelines will be made. “Big Generic” is a force to be reckoned with.
As to the Amneal, I have heard nothing. But the thing is: If the Concerta generic does not use the OROS delivery system, it’s unlikely to have the same delivery as Concerta. And that is what makes Concerta, Concerta: the delivery system. Otherwise, the medication inside the capsule is the same methylphenidate that’s in all the methylphenidate products (Ritalin, Ritalin LA, etc.).
Good luck and stay vigilant!!
g
Also. took your advice about ordering through the online pharmacy but Healthy Children NYS policies have no online pharmacy benefit and Dr . (of course) won’t proscribe to me.
I am the picture in the dictionary next to persistence. I am polite and nice and whipped off my wig before entering every pharmacy to be the bald chemo patient I am trying to help my child to work my way upstream….Every pharmacist was gracious, helpful and did their best but I have little and less to show for it. It’s not our local people, it’s their evil money-grubbing distributors. Trigen provides a better profit so even if my insurance covers the Actavis/Teva the wholesaler won’t order it.
Darn. At some point, if you financially qualify, you might want to check out some of the newer stimulant formulations. Because those companies are trying to build up market share, they have pretty generous savings programs.
But you might also want to check out the Concerta patient assistance program. http://www.janssenprescriptionassistance.com/concerta-cost-assistance
best,
g
Haha! I see you there in the dictionary!
With chains, you’ll never get anywhere talking to the local people.
Just to be clear: CVS has been an extremely bad actor in all this and it extends throughout the system, up and down. CVS profits greatly from insisting on these generics rather than the more costly authorized generics (Actavis).
Walgreen’s has a much better track record.
At any rate, the request has to be made not to the person behind the counter but through your insurer’s pharmacy benefit. If that is Healthy Children, though, that will probably go nowhere.
The assistance plans might really be worth looking into.
best
g
My Dr. wrote Actavis/Teva but CVS still won’t order it. It’s not your local CVS it’s their supplier, the distributor, who refuses to order it. You friendly pharmacist doesn’t care and would order it–it’s the higher ups who refuse to order it. Absolutely disgusting. Luckily for us the Trigen is working.
Hi Krishur,
I’m glad the Trigen is working for you.
You might be able to escalate your request if you ever want to try again.
best
g
Katherine, I’ve been able to get our last 6 months worth of Actavis Concerta through Walgreens. Instead of going through insurance, which steers us to use CVS, I’ve used a good Rx coupon. It is undoubtedly expensive, but for us it’s worth it to have the brand that works. Hope this helps. Best of luck.
Hi Samantha, Thanks for sharing your experience with Katherine and all.
FYi – The pharmacies DO have access to the Actavis generic. Even CVS.
They will put up roadblocks. They will give you double-talk.
But if your MD writes Concerta – Actavis authorized generic only – that should work.
You could call the pharmacy and ask what it requires.
Pharmacies make a LOT more money on the crappy generics.
g
Thank you, thank you, thank you for this post. I am finding it quite late, but it explains why my pharmacy told me a few months ago that they can no longer order/get the Actavis manufactured generic. I’ve been getting the Trigen manufactured generic for months now and it does absolutely nothing for me, which has in turn has caused a major depression flare-up. I mean, when you are undermedicated and completely unfocused and feel entirely unproductive, who wouldn’t begin to feel hopeless? Anyway, after reading your post and the comments, and following links, etc. I feel armed to the teeth in my mission to find any remaining Actavis/Teva manufactured generic!
I did see your update about Amneal launching a generic and did some digging. You can find a pic of the tablets here: https://app.catsy.com/amneal-generics/#/. Doesn’t inspire any hope in me.
Again, so glad I found you! I look forward to checking out all the other resources you have to offer!
HI Katherine,
YAY!!!
Thanks so much for letting me know. You boost this blogger’s flagging energy.
It’s horrific, what is allowed to happen.
I chewed out our new insurer, over ridiculous stalling tactics for the home-delivery Rx for my husband.
“How DARE you do this to people who already have trouble with perseverance, organization, and follow through. That’s why they need the medication!
“Is that what you’re counting on? That you can wear them down? That is cruel. It is fraudulent. It is horrible.
“You foist crappy generics on unsuspecting people—including CHILDREN—and you don’t care that it sends their lives off the rails..
“Shame on your CEO and his HALF A BILLION DOLLAR package this year.
“Sinful. Shameful.”
I did go on. 🙂
And this was to the “executive trouble-shooter.” She’s not likely to forget THAT conversation any time soon. lol!
Be strong! Don’t be bamboozled!
g
I have a question regarding my (14 year old) grandson’s medication, and I thought you would be the perfect person to ask. The pediatrician recently increased his Concerta dosage to the maximum allowed of 72 mg (2 – 36mg tabs). We have only had limited success with the meds during school, and he starts high school this September. When I asked the doctor what we might try instead IF we don’t see much improvement with the increased dosage, he indicated there were some tests we could run to see how different meds would work and metabolize in his system (without doing a trial and error of actually trying the different meds). I was ecstatic that this type of test was available because I have had my doubts if Concerta is really the best option for him – but, I have never heard of this type of test before. Do you know anything about this, or if it’s something new? We tried Adderall when he was younger, and the mood swings/crying jags were horrible – so, that med is probably not the best option for him. Thanks for any info you can offer.
Dear Carol,
You are right: I am the perfect person to field this question. 😉
Most docs are (I’m sorry to say this) sloppy and reckless when it comes to ADHD treatment. For example:
1. They don’t use rating scales, so as to gauge improvement of symptoms or development of side effects.
2. They don’t do careful trials of EACH stimulant group (Amphetamine and Methylphenidate), at various doses.
3. They start too high instead of starting VERY low and increasing slowly.
4. They fail to assess for co-existing conditions (e.g. anxiety, sleep disorders, depression, etc.), and those conditions can be exacerbated by the stimulants. There needs to be a careful balancing of stimulants and whatever is necessary to treat those co-existing conditions. Sometimes an anti-depressant combined with the stimulant, for example.
5. They don’t even ask about dietary habits, perhaps because they fail to understand the importance of nutrition for both brain/body functioning but also for processing the medications.
6. They don’t ask about sleep habits. Sleep disorders are common to ADHD but they differ, with each requiring a different approach.
7. They don’t ask about substance abuse (e.g. marijuana, caffeine, videogaming, etc.).
8. They don’t seem to realize that a person with sleep deficits will not typically respond well to stimulants.
9. They don’t ask for third-party feedback from parents, etc. (with teens; this is typically done with younger children).
10. Finally, to answer your last question regarding testing, the prescribers fail to understand the limitations or even the basic meaning of this genetic testing.
A few years ago, I heard from parents taking their children off stimulant medications “because the genetic testing said this wasn’t a good match.” I was appalled. That was bad information, and it was adversely affecting those children’s lives.
So, my scientist-husband and I wrote a 7-part blog series. You needn’t understand or read all of it. But do skim to catch the highlights on what this testing means regarding prescribing.
ADHD, DNA, and Predicting Medication Response
Bottom line: Patients and parents must absolutely self-educate. Don’t depend on the average prescriber to guide ADHD treatment.
I hope this helps.
Gina
Thank you for all you do to fight this craziness and keep us informed!
Aw, thank you, Chrissy, for taking the time to be kind. I appreciate it.
The situation is constantly and quickly evolving, but I do try to keep up!
best,
g
Thanks so much, I was told I couldn’t do mail order, but it looks like I can.
Hi Kris,
Good.
Yes, there are many myths and misconceptions about mail-order when it comes to stimulant medications and other Schedule II Rx.
That’s why I wrote the post. 🙂
I hope it works for you!
g
I have been to all 5 CVS’s in my area, Walgreens and 3 independent pharmacies. Purchasing on line is not possible b/c it’s a controlled substance. I just got off the phone with Janssen and Teva. Janssen confirmed that Teva is the authorized generic and even transferred me to Teva’s Concerta help line. Teva confirmed they have product and are shipping. They said that if a wholesaler is not allowing a pharmacist to order their product, a consumer’s only recourse is to keep looking for pharmacies that use a wholesaler that will order the product. That’s why we are seeing reports of some people getting it and others not. Very sadly, I believe it’s as you said, Trigen is more profitable so they make it impossible to order the Teva. I hate to be that, “Let me speak to your manager” person, but I have a refill next week and will keep swimming upstream until I get a hold of someone that get my daughter what she needs.
I have tried all 5 CVS’s in my area, Walgreens and 3 independent pharmacies. I just got off the phone with Janssen and Teva. Janssen confirmed that Teva is their authorized generic and transferred me to Teva’s Concerta help line. Teva confirmed they have product and are shipping (2 week back order for 27mgs)–if the wholesaler is not allowing the pharmacist to order it there is nothing they can do to help. The only thing a consumer can do is find a pharmacy who’s wholesaler will let them order. Seems we need to go up the food chain and speak to the wholesalers. I suspect it’s as you said, the profitability on Trigen is better so they make it impossible to order the Acatavis/Teva. I have a refill next week, I hate to be that person, but I’m going to ask to speak to the manager and swim upstream until I get my daughter what she needs.
Good luck, Kris.
As I said, you could save yourself a lot of wasted effort by going with your insurer’s mail-order pharmacy, if you have that option.
https://adhdrollercoaster.org/tag/mail-order-pharmacy/
And again, yes, I’ve reported that Teva purchased Actavis, which had the agreement with Janssen to distribute the authorized generic.
What we do NOT know is details about the new marketing agreement, if one exists. They might just be reducing existing supply.
g
Also, Teva has the tablet on their website. Not sure if this is simply b/c they took over Acativis’ left over stock or b/c they do have a deal to market it, as I was told by their customer service reps they do. https://www.tevagenerics.com/product/methylphenidate-hydrochloride-extended-release-tablets-usp-cii
Yes, I cannot get a straight answer out of Teva, either, as to the terms of the marketing agreement and how long it might last.
I suspect negotiations are ongoing between Janssen (the manufacturer) and Actavis/Teva (the distributor of the authorized generic).
Or, they are continuing to sell it until the supply is exhausted.
This is most unusual, to have no information publicly available.
g
In February I contacted Teva and was told by email and over the phone that they have the license to market the generic Concerta; it was a matter of getting a pharmacy that is a TEVA distributor to order it. CVS is a Teva distributor. Several CVS stores in my area tried but were told by “higher ups” that Trigen is the “preferred generic” and in any case they could not order it. I’ve been running around from CVS to CVS exhausting their supply. I’m down to the last one in my area–about 2 months worth left. Knowing I’m running out and giving it time for Teva marketed pills to reach the market, I’ve reached out to small independent pharmacies and they too are being told by their wholesalers that the ALZA tablets are unavailable. Summer seems a good time to try the switch, which generic seems to be the best tolerated?
Hi Kris,
Ach. It’s so distressing to have to deal with this mess all the time, isn’t it?
My husband switched jobs recently and knowing that yet again I had to tangle with a new mail-order pharmacy gave me the heebie-jeebies. 🙂
Let me clarify some things that might help your situation:
1. Yes, since purchasing Actavis, Teva distributes the authorized generic for Concerta. As I have reported.
2. Remember, the authorized generic IS the brand. It is only marketed as a generic.
3. CVS, throughout years of dealing with these inferior Concerta generics, has shown itself to push the more profitable Concerta generics over the authorized generic (brand). I have many reports where the CVS pharmacist misrepresented the truth to consumers, insisting that the downgraded generics could still be substituted for brand. (Meaning, the customer had to accept that or get nothing.)
4. I know many people who have continued to receive the authorized generic. There is no question of waiting for a supply.
5. The situation you describe sounds as if CVS can get the authorized generic but refuses to. Most likely for profit reasons. The non-authorized generics (e.g. Trigen, etc.) are more profitable to the pharmacy.
6. I wonder if the independent pharmacist you visited need different information. Instead of asking for ALZA, ask for the Concerta authorized generic distributed by Actavis/Teva. (Either name might be in their computer system.)
7. Other pharmacies contract with Teva. Have you tried Walgreen’s? Target? How about a mail-order pharmacy? Does your insurance provide that option? That’s often the best.
8. As to your question, which generic seems to be the best tolerated? I cannot say. I have not heard positive reports about any of them being similar enough to Concerta. Now, some people who don’t do well on Concerta might do better on these generics; it just depends on individual neurochemistry.
9. This might be a good time for you to try other stimulants if you haven’t already. Perhaps Vyvanse, which has no generics yet. There are some new stimulants being promoted with generous savings programs. Aptensio. Evekeo. etc.
I hope this helps.
Gina
Have a son with ADHD and been on M. (Methylphanidate) derivatives for years. But the big price hike about 18 months ago (more than double $$) has driven us to look for alternatives. My son takes two 20 mg M. ER tablets in the morning and another one after lunch to help him thru the rest of school and after school homework.
See *** at bottom for drug specifics.
The above has worked well but 3 of these a day is expensive. We cannot afford this anymore. So looking for options: probably the M. ER 54 mg Actavis.
BUT WANT I REALLY WANTED TO SHARE:
1)
Really work all the systems for a best price.
2)
Try the prescription coupons that you can get all over the internet. For us they are MUCH cheaper than “insurance negotiated prices”. No need to give person info. I found werx.org to be the best as it does not add erroneous descriptors to the drug name that will be rejected by some pharmacists.
3)
Don’t bother shopping unless you have a paper prescription in hand. Could not get to first base on understanding what they carried and costs without presenting the prescription.
This is kind of a catch 22 as ideally you would like to get the list from the pharmacy, then go to doctor and then get prescription for what works and is affordable. So use the prescription coupon web sites to do price analysis. Then prepare for battle.
4)
If your local pharmacy guy is really unhelpful or down right uncooperative with your cost saving efforts, go to a different location of the same company i.e. if the Walgreens down the road won’t work, try the next one over. The guys behind the counter can be very different. And yes CVS is terrible. Gave up on them. But there is Costco, Walmart, Safeway, other grocers, and some independents besides the big 3 pharmacy chains.
5)
Yes the manufacture matters! And this is not just for Concerta and it’s generics. Having your doctor specify the manufacturer does help you get what you want but FYI: it can also cause hassles at the pharmacy. Like if they do not carry it then the prescription is worthless there.
Good luck. My efforts at the above lowered our costs from $375/mo. to $231/mo. That is huge on an annual basis.
And thanks for this great web page!
Dana
*** K76 Pill Images (White / Round) K76 (Methylphenidate Hydrochloride Extended-Release 20 mg). It is supplied by KVK-Tech, Inc.. Methylphenidate is used in the treatment of adhd ;.
Great tips, Dana!
Thanks for collecting and sharing!
Gina
Thank ahoy for posting this! I just got my RX filled and my husband picked it up. As I looked at it, I noticed it was the round pills that you have pictures of. I called and my pharmacist said there’s nothing I can do right now. Gave me information to tell my Dr next time I need it filled and they still can’t guarantee that I will get it. Also! After reading your post I looked for the tiny hole on the pills. Out of my 30 pills for the month 17 DID NOT have a
Tiny hole.. it makes me angry that people will lie and cheat the system for a few dollars and the people who need this medicine to function properly in their day can’t becuase of their (big pharm) selfishness.
Hi Bethany,
Sorry that happened to you. In this case, it’s not “Big Pharm” but “Big Generic”.
Concerta is a well-developed, designed, and manufactured medication for ADHD. It’s so popular its market share is being targeted by several generic manufacturers. So many, in fact, that I cannot keep track of them.
I’ve heard that the presence/absence of visual signs of the holes doesn’t affect how the medication is released — that the coating dissolves quickly. I am not so sure.
Since you already have the pills and apparently cannot return them, it’s worth trying. Also, if you want to convince your insurer that you need the brand, you’ll need to show that the generic performed poorly.
As if people with ADHD and their loved ones don’t have enough to manage….
Good luck,
Gina
As so many people have said, the Trigen version did not work for my boys. Both my 6 year old and my 15 year old had significant problems when they received Trigen. My 15 year old started have severe stomach pains every morning about 10:30 AM. It took me a week to figure out it was the dye in the new generic. We had to pay for the brand name for 2 months then suddenly 3 different pharmacies in our area had Actavis again. His doctor now puts DAW on the prescription which allows us to get either Concerta or Actavis. My 6 year old’s behavior regressed to the days before he was on any ADHD medicine. Suddenly I was getting calls from the school asking if he had taken his medicine. After getting 4 calls in 2 weeks I started researching the new generic and found this blog. He is back on Actavis now and is doing so much better. Thank you for providing this very valuable information.
Hi Sheila,
I am so glad you were vigilant and connected the dots!
I just think of all those people experiencing this phenomenon and assuming other causes, meaning these kids don’t get the help they deserve.
Thanks so much for writing.
Gina
What in the world do these manufacturers think they are accomplishing by putting RD#40 in these medicines? I might as well give my son a snort of crack and 6 pack of Mountain Dew! Unfortunately I have an $8,000 deductible so I’m going to be out of pocket for just about all of it. Yikes.
Oh dear. At least you realize it’s a problem for your son. “Big generic” has some issues, and most people have no idea.
Maybe you can identify one of the newer stimulants that will work well for your son — and enjoy the cost-savings for new customers.
And if not, push for the authorized generic (same as brand).
Good luck,
g
Gina, THANK YOU for this amazing post.
My son has been on generic Concerta for 3 years. The timed release has worked really well for him — he had a very difficult time with short-acting or “long-acting” medication. However, when he went back to school in early January this year after the winter break, he started having a lot more behavior issues. His behavior issues also went through the roof at the after-school program. We have been at our wits’ end trying to figure out why he’s having so many problems. He turns 11 in August so we have been wondering if maybe it’s puberty kicking in, or if maybe the dose of Concerta he’s on just isn’t high enough. He already takes the 54mg dose so I am reluctant to increase it even though his psychiatrist brought it up as an option.
So, I stumbled on this blog post completely by accident — I was actually googling something else about methylphenidate and this happened to come up as one of the first search results. I started reading it and thought, OMG, around the time his behavior change, the shape of his pills changed to round pills. I hadn’t thought anything of it because, well, generics are always supposed to be the equivalent of brand, right? So I went back to the pharmacy receipts for the last several months and confirmed that he had switched to the Trigen generic right when he started having problems. It looks like we also had the Mylan generic for two months and the Impax generic for one month, so evidently none of the new generics work for him. 🙁
I will ask his doctor to subscribe the brand-name only, however, I have a feeling we are in for a fight with our insurance to get them to cover it as normally they won’t cover ANY of a brand-name drug if there is an approved generic. But I am also super relieved at the same time because this completely explains the changes, and why he has struggled so much more at the after-school program (by then the med is probably completely out of his system since the problem he had with the long-acting meds is that they went through his system very quickly). I have also filled out the MedWatch form to explain what I have seen. Thank you again for the time and effort you have spent on this!!!
Hi Jen,
Great detective work! Good for you!
I’m glad you accidentally discovered this post.
It’s crazy, isn’t it, how pharmacists (and everyone else) will try to head-pat us and say, “no, no, generics are exactly the same as brand.”
No, no, they aren’t. Sometimes it doesn’t matter. Sometimes, it matters immensely.
Instead of asking for brand, you could try to get the authorized generic. That will still be a cheaper option for your insurance company. And it IS the brand for your boy.
Sometimes this involves your physician writing a letter stating why this is necessary. In your case, your son has already tried the generics, to poor effect. Now the doc just needs to say that.
I’ve found that supplying docs with a draft of such letter, including the particulars, expedites things and reduces the burden on the physician.
good luck!
g
A question for DMichael: It sounds like you are reporting on your very first day on Trigen generic? If so, could you let us know how it is going for you in the future? I had decent days with the Trigen version, but mixed in with too many days with side effects that seemed to wipe out any positive effects. On the whole, it was quite disappointing. I could not rely on it in the same way which was confusing for my work & family life. Now that I’m back on the Concerta, it gives me the same consistent mental energy each day.
Knowing more now about all the loopholes in the rules for generics, that makes sense to me. This whole discussion reminds me of tales from friends over the years: Their lives (or their children’s lives) had been upset when they were forced to switch to inferior generics of other medications (for seizures & such). Often it took them a while to figure things out & convince their insurance & doctors, if they were lucky. I hope the generic will continue to work for you, though! Thanks for the heads up on http://www.parpharm.com.
Hi Ruth,
I’m not sure about parpham.com and I could find no listing for the authorized Concerta generic.
Teva bought Actavis and is the company now holding the (apparent) agreement with Janssen to distribute the authorized generic.
I can get no one to go on the record about this deal. It’s very suspicious, as the original marketing deal was widely known. Perhaps the negotiations are ongoing.
g
Oh, forgot to add. Ask for generic from Par Pharma, that are still dist. the ALZA’s Hope that helps.
Hi Sean,
I’m glad you are having good results from the Trigen generic.
To be clear: The Trigen Concerta “works” for you.
I’ll repeat one more time: The fact that this medication works for an individual—perhaps even exceeds Concerta’s performance—has nothing to do with how well it approximates Concerta. And that is what generics are supposed to do: be very similar to the brand as far as the “release profile”.
You said that you 1) like this better than Concerta, and 2) are taking a lower dose (27 mg) than you were taking of the Concerta (36 mg).
1. This generic might suit your neurochemistry better than Concerta. Great. If it were called something else, had its own name, no problem. The fact that you like this generic better than brand Concerta suggests that it does work differently. And that is why it might NOT work for people who do well on Concerta.
2. You’re taking a significantly lower dose. So it’s really comparing apples and oranges.
best
g
Not sure why the complaints. I was mad too but thought I would try it. It’s been an smooth ride. I took at 8 am And by 9 I was feeling all warm all over and went on to have a productive day, no side effects, no racy feelings. At 230 I started to fall a little and thought this will not work. By 3 p I’m off on my second lift off, I actually like these better than alza’s. and this is with a dose reduction for the first time, my 27’s are treating me better than my azla 36. Don’t let the small pill throw you. Trigen’s Concerta’s work.
Re Mary’s & Sarah’s posts, I want to reiterate that I feel Gina is offering a priceless service as a consumer advocate on this blog. Her posts consistently show balance & also respect.
I can just imagine how much time it must take to write all those careful detailed replies to the many distressed individuals posting here. Thank you, Gina, for putting yourself & your reputation on the line & for applying your brainpower to this messy but important topic.
I think there is a good reason why her blog has won awards & why she is a known expert in this field. I personally will go on to read her books & study the rest of her website, knowing now that she digs in deeply & doesn’t easily get fooled or intimidated by the “official line” she is getting from the pharmaceutical companies etc.
Re Mary’s statement: “There are surely many more patients responding positively to the Trigen generic than not!” I want to ask: how can we really know this? It is just an assumption. Thanks to the internet & sites like these, we can get a rough idea of how many people are affected by the introduction of these generics. But it is such a subjective “science”, & many people with ADHD will just blame themselves for being less functional, or they may have a hard time being objective about the differences. Or as Gina mentioned, they will feel discouraged & discontinue treatment.
I’ve read enough shares now to see that it can take a long time for it to dawn on people that the “bioequivalent” substitute is not helping them the same way. That was also my own experience, & without the information here I would still be fishing in the dark. Most psychiatrists will not have the time & wherewithal to do this kind of research. Sharing Gina’s blog was an easy way to convince my doctor that something was fishy.
Thanks again!
Dear Ruth,
Thank you so much for taking the time to write your kind comment.
I appreciate it.
Indeed, producing this blog does take an immense amount of work. My motivation is knowing that it makes a real difference in real people’s lives. Like yours. 🙂
best,
g
Thank you, Ruth, for writing my thoughts! 🙂 (I am not good at writing.) Thank you, Gina, for your invaluable work on ADHD.
Thanks, JoAnne. I appreciate it. g
Gina. I somewhat agree with Sarah but only in the regard that you don’t mention much how very different each patient responds to medications. There are many more patients doing just fine on the Trigen brand generic, including my son. And contrary to what you post over and over again, the Trigen generics use an extremely similar delivery to OROS. The biggest difference in the Osmodex system is the shape and color. They are both osmotic pump systems with a laser drilled hole where the immediate release layer dissolves in an hour and the remaining drug is released at a controlled rate throughout the day. For the newest 72 mg dose, there were new studies that showed near exact data at all metrics and time points to taking 2-36mg tablets. It has true bioequivalence & therapeutic equivalence. I’m sure there are some real cases where patients respond differently once stable on Concerta for a length of time, but much of this may be a self fulfilling prophecy from reading so many negative comments. Do you even ask for stories of positive results? People tend to only complain about things but rarely take the time to post positive comments. I think you should reconsider advising concerned patients/parents from even trying their meds to see how it works for them. In some posts you outright advised to not even try it. I appreciate that you’re an unpaid advocate, but a bit more balance and less fear mongering is warranted. And the Osmodex technology is not some cheap foreign knockoff as indicated above. Trigen is a US company and the Osmodex delivery technology is used in some other very well known and respected medications, such as Allegra D 24-hr tablets and others. You offer some very good information on your blog, but please consider a bit more balance. There are surely many more patients responding positively to the Trigen generic than not!
Hi Mary,
Thanks for your comment. I mean, the lecture. 😉
1.
Perhaps you didn’t read the post. Close to the top, I wrote this:
1. Bottom line: What do Concerta users need to know?
Chiefly, that not one of these three generics uses the patented OROS delivery system that is central to Concerta’s delivery system. (You’ll know it’s OROS if it says “Alza” on the pill.)
As a result, many people will find the generic doesn’t work as well as the brand. Yet, some people might actually prefer the generic. It all depends on the individual.
If brand Concerta works well for you or your child, however, and you don’t want to risk going off the rails, you might not want to risk it.
Here is a post consisting of first-person stories detailing adverse reactions to the downgraded generics: Sound Off: Users of Downgraded Concerta Generics
2. Can you please substantiate this research that you site — that “there were new studies that showed near exact data at all metrics and time points to taking 2-36mg tablets.” According to my sources, the FDA again allowed a generic manufacturer (Osmotica) to substitute the data from Concerta’s clinical trials in their product-specific information, instead of requiring them to publish pharmacokinetic data specific to their product. This is one of the problems with the generic-approval process.
3. You fail to understand that “true bioequivalence” is nothing to brag about when it comes to medications that often require very precise dosing. Bioequivalence allows 20% variance up or down. Plus, there are different binders, fillers, etc. I wrote about this years ago. Where I did in fact note: Yes, sometimes generics work okay for some people. When it comes to affordability, sometimes it’s the only option. For many other people, however, they create more side effects and cause them to stop treatment altogether.
One workaround: Try the brand name of the medication to make sure it works for you, before switching to generic. At least, you will have then eliminated one variable.
I find it’s always good to have your facts before you accuse.
https://adhdrollercoaster.org/tools-and-strategies/consumer-reports-on-vacuum-cleaners-maybe-on-adhd-medications-definitely-not/
4. I offered the space for anyone to offer positive comments. Contrary to your supposition, I did not start out looking for negative things about these drugs. I started receiving e-mails of lives going off the rails.
5. I’m not just an unpaid advocate. I am an internationally recognized ADHD expert. When you have done more research on this topic, and have talked with as many people as I have, I will bow to your expertise. Until then, my posts stand and I find your criticisms unwarranted.
Perhaps it is you who needs to develop more appreciation for the potential hazards of these generics, the manner in which they are introduced by pharmacists (as “exactly the same” when they are absolutely not), the cost-savings ploys from insurance companies, etc. and to have more empathy for users.
If by “more balance,” you mean that I should become a sycophant for generics manufacturers, thanks, but I’ll stick to factual balance.
Gina
As an adult living with ADD, I can completely understand how an unauthorised generic substitution by any pharmacy could be upsetting. However, when the generic option was removed without any notice to me, that left me with a staggering bill after a long and difficult struggle to find a medication that worked for me. The generic did that! Even with my improved mental health after finding a MDD treatment that helped, but still required the assistance of ADD medication, I am not a fully functional member of society. I work fewer hours than most, for minimum wage, and an erratic schedule. Because of the forced switch to brand-name Concerta my insomnia has returned, I’m assuming because of the extended release formula. It’s deeply troubling to me that because of others petitioning against a drug that they could have easily obtained by communicating with their pharmacy and doctors, I am now struggling to get an hour of sleep before a 4am shift. The generic was working perfectly for me and when my mandatory generic insurance finally kicks in, I will still be high and dry in terms of any savings that might help me re-build my life, if I can’t find a new generic substitution that works.
The complaints you pile up against generics are far louder than the thousands who are satisfied with the substitution who now are forced to scrape up an extra $70 a month, miss work for a prescription re-write if they can find a generic supplier, and I don’t think our needs should be disregarded. There is no one-size-fits-all solution in these mental illnesses, they are a spectrum, and thanks to this extended release being far more extended for me because of digestive side effects from the one depression medication that helps me, I am left wired at bedtime. I’m only leaving this comment so others know it is not just because I am poor that I require the generics. The faster rate of absorption helps me sleep when I need to, and no, I am not crushing them up and snorting them, I was finally feeling like a normal human being and thanks to your ableist, elitist attitudes I’ve just had the rug pulled out from under my feet. Please have some respect.
Hi Sarah,
I deeply appreciate your distress. And I will overlook your attacks (calling me “ableist” and “elitist) for that reason.
You might think that I do this for fun. I do not. I am an unpaid advocate who took on this cause due to the many queries I have received.
I included some of these stories of lives going off the rails with the previous Concerta generics in this post:
https://adhdrollercoaster.org/tools-and-strategies/sound-off-downgraded-generic-concerta-users/
In other words, please be aware that other people exist in the world and their experiences are different than yours.
One very counterproductive “coping strategy” common to late-diagnosis ADHD is blaming other people. Your blaming me for your situation is an example of that.
Moreover, you seem to not understand the point. When a generic purports to work as well and in the same way as a brand, it should do that.
These generics are not standalone medications. They are claiming to be equivalent to Concerta. For the millions of people with ADHD who have found that Concerta works best for them, that is tantamount to fraud.
You don’t mention which Concerta generic worked best for you — e.g., the Mallinckrodt, Kremers-Urban, etc.
Overall, these generics are closer to Ritalin LA than to Concerta. Maybe you want to try that.
Good luck
Gina
Another very grateful reader here! Also glad to know I’m not making this up. It explains what I’ve been experiencing, & I’m feeling just as enraged as you all. If you don’t want to read my report below, here is my main point: Walgreens in San Diego told me they are still planning to get the (good) Concerta from Actavis saying “That is the kind we always get.” 2 different reps assured me they don’t see anything in their system indicating that they are changing suppliers, with the caveat that they can’t guarantee that it will stay that way. . .
My experience: I was quite disappointed with the Trigen 18 mg version, after having done very well with Actavis Alza 18 -the Trigen is less strong & consistent, extreme fatigue & yawning “attacks” about 3-6 hrs in, sometimes upset stomach or dizziness, irritability, feeling jittery, less clarity of thinking. Having said all that, I am still taking it while I’m working on getting the Actavis again. I find it is better than nothing, & the real neg. side effects don’t occur on most days. Some days it seems to have decent effects, I just can’t rely on it the same way as with the Actavis.
On 4/25, the local CVS (San Diego) would have actually given me 30 of the Actavis Alza 18 pills that they had left over when I asked. But when she ran it through my Blue Shield ins. she showed me a sheet stating that I was only qualified for the Trigen version. CVS also told me that going forward they will only carry Trigen anyway, & this would have been an exception. I sent Gina’s blog to my dr. asking for her to specify that I needed the Actavis only. The Dr. resent my prescription to a Walgreens where I had checked they still had at least 1 bottle of the Actavis generic on the shelf. Walgreens said they also could get more of it. Now I have to wait til 5/18 to try to pick it up. They couldn’t tell me yet if it would be covered by ins. At both Walgreens & CVS, the cash price w/o ins. would be over $250 for 30. Also called Blue Shield – the rep initiated a conference call w/ my local CVS. Through a confusing conversation, they seemed to determine that it really was Blue Shield that blocked me from getting those precious last 30 of the Actavis at CVS. I was told to ask my dr to send a prior authorization to the ins. specifying why I need that brand. I will write it out for my dr. with as many details as Gina & you all specified, to make a strong case. Also I promise I will fill out the Medwatch report, already bookmarked the report page. (https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home) Thanks again to Gina for helping us to become informed consumers & to hopefully convince the FDA again as well!
Hi Ruth,
Thank you so much for taking the time to write that “field report.”
I need to find out what the rules might be, around a consumer being able to specify a generic. Specifically, if there is an authorized generic (brand marketed as a generic), what is the consumer’s right to have that over the “true” generic.
And who makes the rules? It seems there are no rules. Each pharmacy benefit plan can dictate the rules.
The “true” generics (Trigen, Mylan, etc.) are cheaper and thus more profitable to the pharmacies.
I’m still waiting for the details promised by the different entities involved. I think they are hoping I’ll go away.
I won’t. 🙂
thanks!!
Gina
Oh, I did take your suggestion and file a complaint on the medwatch website.
Good for you! It’s ridiculous that we have to do this….
I am so glad to have found your information! Our insurance policy requires that we use mail order for all maintenance prescriptions (ones you take on a regular basis). My son has taken Concerta (of various doses) since the 1st grade; he’s now in 10th. In late Nov 2017 we received weird looking pills (first thing I noticed). I googled the number on the pill to make sure we weren’t given the wrong thing (the others had always been tubular and said “Alza” and these were round. They were the ones by Trigen. I deliberately didn’t tell my son anything because I didn’t want to bias his opinion. He asked about the different shape and I told him they were a different brand that was supposed to work the same. After school, I asked how the medication had worked. “Horrible. I couldn’t concentrate at all!” Then I did a little research and found out other people had reported similar problems. I called his Dr. who was outraged that they had been supplied as a generic for Concerta, stating that they were not the same thing at all because of the time release. I had to end up ordering a 3 month (EXPENSIVE!) supply of name brand Concerta. Now we’re in 2018 and he needs his medication refilled. I called the mail order company (Optum Rx) to make sure they weren’t going to send me the Trigen brand again. Surprise! Now they changed our policy so that it no longer covers a generic for Concerta. They suggested I call the insurance company to request a “transition of care override” so I could be allowed to buy the Actavis generic from a CVS or Walgreens instead of being forced to buy all maintenance medication from them and they wouldn’t supply it. However, while on hold I found this article and is sounds like there currently is NO equivalent generic for Concerta. What a mess. Gina, thank you for all your research! Is there anyway we can sign up to get updates when/if you find out more about the Actavis/Jansson agreement? Thank you! So good to know I’m not crazy and that other people have reported the same thing.
Hi Anna,
I’m glad you found my blog, too.
I’m not sure what you mean by this: “sounds like there currently is NO equivalent generic for Concerta.” Do you mean the authorized generic, sold by Actavis (which is now owned by Teva)?
An authorized generic is the brand marketed as a generic.
I have calls into Teva, and the company is being very cagey. Perhaps they are still re-negotiating the contract and selling the authorized generic in the interim.
As for getting updates: If you signed up for my blog (via the pop-up window that should have appeared), you will receive updates. There was also a signup at the end of the post — and in the right column, a green box.
http://www.ADHDRollerCoaster.org
Same thing happened to me with OptumRX. My Psychiatrist even did the pre approval and they denied me. I am now stuck with inferior medication. It’s easy to tell it wears off earlier than the authorized generic.
Hi Scott,
Argh.
Now that you’ve tried it and found it inferior, you can appeal. If your doc will write a letter explaining such.
To facilitate, I typically write a draft for the doc. Of the particulars.
Good luck!
g
Gina,
I’m so glad I found your website. Very informative. Thank you for that.
My son just switched to concerta, alza 54..It is red. My son has reactions and is allergic to red food dye. Figured we were in for another long road with medication trials but good to know no food dye in this pill. It was hard to find information on that. So thank you.
FYI…no food dye (red especially) in my sons diet has made a world of difference in my sons demeanor. It was a night and day difference. It is worth a try for anyone looking for a little more calmness in a child’s life. We do a lot of shopping at Trader Joes (more natural options)
Hi Sheri,
Welcome to the ADHD Roller Coaster.
Yes, the dyes can be a huge issue for some people with ADHD.
And most folks don’t realize that the generics are more likely to create problems in this area.
I’m glad you figured out the connection with your son.
g
I just today called both Walgreens and CVS near me and both have Activis generic. They did say they would need to “order” it from their warehouse, but for sure had it (54mg). I
Wow. Thanks, Andy.
CVS/Caremark has denied having the authorized generic, and it’s cost us big-time.
I have queries in to Walgreen’s corporate and Teva corporate (Teva purchased Actavis a while back).
I hope to have the low-down soon.
tx!
g
Thank you. I will heed your advice and check back in. Thanks for all you do!
Hi again,
Any reports/information about Contempla? Our pediatrician prescribed Contempla XR-ODT 8.6 mg. for my son. He was taking methylphenidate 18 mg ER (Actavis), then briefly had the Trigen (nightmare), now we are trying Contempla. He does not have the tic he acquired with Actavis (clearing throat), and he says he is able to focus at school, but lately he’s been quick to anger and tantrums later in the day. He is almost 10. I’m not sure if it is related to the pills or not. he does get angry when he is hungry, but even after he eats he can get a little nasty. Thanks for any insight.
Hi JoAnne,
I was just reading up on Cotempla today. I’ve heard not one report about it. Yours is the first.
It’s so hard to say. All of these medications have different “profiles’ — the rate at which they are released, when they peak, how fast they ramp up and tail off.
Much of it is going to depend on the individual.
If you’ve talked to him and found that there’s no particular issue that’s behind the anger and tantrums, I would definitely tell the MD.
Sometimes, it’s not enough to tell….we have to “spell it out.
So, the more you can observe as to how long the medication seems to be lasting, the better you’ll be able to tell the prescriber if it seems like the medication is wearing off earlier or if it’s rebounding (where symptoms return worse than at baseline).
Try some other objective tests to judge when the medication is wearing off….does his handwriting start going off the rails? Does he get more wiggly, argumentative, etc.?
These medications’ duration can vary a great deal with each individual.
I will be writing an article soon on the new stimulants, of the last year or so.
Good luck!
g
I was wondering is the new. Round pill as good as the alza cause im afraid to change my daughter was doing great on that old one and then they change it and im afraid she wont be able to swallow it as well
Hi Ashley,
Reports thus far on the round Mylan generic for Concerta are not good.
g
Got it! Thanks
Just wanted to give a quick update on my situation that might be helpful to others.
I ended up calling my local Rite Aid (which has a Walgreens pharmacy in it) and the pharmacist said the Actavis generic is back! The doctor wrote a new Rx for the new pharmacy and the pharmacist was able to do a treatment change override (not sure that is the exact term) so that we could pick up the new medication earlier. Picked up medication Saturday and the pills are stamped Alza 18 as expected.
My daughter has been doing well on them for the last few days. Some headache and nausea complaints but I’m hopeful that will go away soon.
HI Michelle,
Surprising! I wonder if this is leftover stock. I can’t think of another explanation, as I’ve found no notice of an extended marketing agreement.
g
Thanks. This was to be his first trial- we have not yet begun anything. Do you think it best to begin on a methylphendiate, and if that is unsuccessful then move to amphetamine?
I will ask about the new one you mention- however does new mean less research on the risks?
Oh sorry. I misunderstood.
The important thing is to start something. I find that it makes more sense to start with a MPH medication, for various reasons, and then try an AMP choice. At LOW doses.
See the medication chapters in my first book: https://amzn.to/2qCbYUQ
Aptensio is a brand drug and has met those FDA standards. it has a different release “profile” than the other MPH choices. It might suit your son better than Concerta or not as well.
You can’t know until you start some trials.
g
Hi there,
I did some research and called Trigen labs. Their product was only recalled for specific lots, and the reason for the recall was that one lower dosage pill ended up in the wrong bottle. Wanted to give you an update on that!
Our psychiatrist has recommended trying Adderall XR since we expressed our concerns about the Concerta generics, and I wondered if I may run into the same problem here, (with the Adderall generics?) She stated that per insurance, it’s likely that Vyvanse may not be prescribed until we fail at Adderall , as well as the same line of thought with trying Focalin XR (only after Ritalin XR has been failed).
All the while, my son’s grades are dropping and relationship strain continues in the family. I sincerely appreciate your time.
Oh, thanks so much, Beth! I’ll update according to your research.
I cannot say their epic fail at quality control boosts my confidence!
Every insurance policy has its own quirks. I recommend asking your insurer these questions before you decide on a strategy. Is your physician just guessing, or is she familiar with your policy?
Absolutely, Adderall generics carry their own risks. But it’s sustained-release system is much simpler than Concerta’s, and therefore easier to approximate in a generic.
Moreover, it is a different class of stimulants: amphetamines. The two classes are not interchangeable for most people with ADHD. One will clearly work better than the other.
Ideally, your son should have been given a trial of each class of stimulant, back when treatment first started. So you should already know how he might do on an amphetamine.
If you qualify for financial assistance, I’d try for the Janssen (Concerta) patient assistance program. If not, is the brand price so prohibitive that you cannot afford a 90-day supply while you come up with other options?
It might be worth checking out the newest methylphenidate option: Aptensio. There are usually generous savings programs with new products: http://www.aptensioxr.com/copay
Good luck!
g
Thanks for the prompt reply and advice, I am communicating with our psychiatrists about these options (and sharing this informative information in the mean time!) When requesting Activis one month ago I did not realize it was being discontinued. I did pick up in store. We may just pay out of pocket for Concerta to simplify life. As a side note, I am a school psychologist with 20 years in the field, and have known about ADD/HD forever, follow Barkley’s work closely, and am SO exicted to now add you to my go to resources! Especially since I see you specialize in adult ADHD and am realizing I have most of the classic adult manifestations of the disorder. I have read it is now best practice that when evaluating children, the parents should also be screened. Brilliant (and yet so obvious). With gratitude, Beth
Hi Beth,
Good for you! What a “value-added” resource you will be now for your students.
Yes, absolutely, parents should be screened. Many professionals are afraid to do so, however, and some simply lack the skills to get through.
One of the reasons I started this work is that I saw, in my local volunteering, that some parents never seemed to get traction in helping their children with ADHD. They would ask the same questions every month at the support meeting.
If I had an established relationship with the person, I’d say, “Did you ever think you might have ADHD?”
And the answer I typically received was, “Oh, probably, but I’ve managed to compensate.”
Trouble is, these particular parents weren’t compensating very well when it came to guiding their children with ADHD strategies, working with prescriber on medication, etc.
Definitely, this motivated my work. I felt for these children.
Thanks for writing.
g
Hi Gina,
I have read through the article and comments and still need some help! I am about to put my 13 year old on his very first dose to manage ADHD. We have been extremely careful and researching for years before arriving to this place. We were prescribed Concerta, and CVS gave a Trigen generic. After reading this, I asked our doctor to ask for Activis generic. She did. We waited 30 more days for the prescription to be filled. Upon arriving today, received the SAME Trigen pills, with a hand note reading Activis no longer available, this is the AB equivalent. We are anxious parents who want to do a trial run in a very mindful and conservative manner. After reading all this, I feel like we should just fork out the $ for the brand name. But I’d rather not go broke. Should we just consider a different medication altogether? Thanks in advance
Hi Beth,
I know. It’s all so confusing.
Where you took a wrong turn is in asking for the Actavis generic (which is the Concerta brand, marketed as a generic).
As I wrote in this post, that marketing deal expired 12/31/2017.
So if you ask for a generic Concerta now, you’re going to get one of the three I write about. (But Trigen has been pulled from the market, so CVS should not have given that to you. This isn’t the first time CVS has done this to people with ADHD. In my experience, you have to stay on them like white on rice, and demand demand demand.)
You say the Trigen “arrived today.” You didn’t pick them up at the store? Most mail-order Rx aren’t for 30 days, but for 60 or 90 days. Always look at them before you buy!
I discourage using generics when first starting to treat ADHD. It adds another variable among too many variables already.
And if you choose Concerta, I encourage starting at the lowest dose (last I checked, 18 mg).
If you haven’t read my book, I highly advise reading my chapters on medication — could save you a lot of grief and missteps.
https://amzn.to/2JBk33V
You could start with Vyvanse, which has no generic, but I think it’s smarter to start with the methylphenidate class of stimulants. If they don’t work, then you can move to the amphetamine class.
The newer medications are competing for market share, so they usually offer generous discount programs. For example, this one from Zenzedi (a dexedrine formulation) — http://zenzedi.com/
In the methylphenidate class, there is Aptensio XR: http://www.aptensioxr.com/about-aptensio
Thank you for reminding me that I should do a round-up post on these new rx.
Good luck!
g
Hi Gina, I’ve been taking Concerta 54mg. for 17yrs. It’s was working very well and I was able to Prioritize my life.
In 2014 or 2015 my insurance didn’t cover it anymore and had to take the generic methylphenidate that didn’t work at all, now thank goodness it’s no longer being marketed because of so many complaints and eventually found not to be equivalent.
So then I was prescribed Activis methylphenidate and it worked just as good as the original Concerta 54mg.
Now January 2018 my prescription was filled with the brand again Concerta (Jansen) 54mg. I was fine with it because I knew before it worked. Well after taking it for a whole month, I experienced the worst weeks ever, it actually exacerbated all and new worse ADHD symptoms.
Even though I really needed my medication, I was better not taking it then taking it, as to picking my poison.
The pharmacist said that my insurance only covers the brand and even though both are made by the same company, a prior authorization for the generic Ativis would not happen…. okay anyway they’re trying to tell me it’s exactly the same and looks the same.
I told them I really don’t care how it looks, I know when I’m not able to live, concentrate, frustrated and worse. So I haven’t been on anything for almost 2 months and absolutely refuse to pick up the Concerta. What happened to Concerta? It used to really work, but now the worse I’ve ever had.
Hi Davina,
Yes, I actually led the effort a few years ago to have the FDA downgrade those inferior generics: https://adhdrollercoaster.org/tools-and-strategies/victory-concerta-generics-downgraded/
To clarify a few points:
1. The Actavis generic worked as well for you as the brand Concerta, because the Actavis generic was the brand — it was simply marketed as a generic.
I explain all this, and more, in this post: https://adhdrollercoaster.org/tools-and-strategies/consumer-qa-on-concerta-and-generics/
2. You say that in January you received the Jansen brand of Concerta but you are experiencing side effects you haven’t experienced before. And so you asked your pharmacist for the Actavis generic. But again, the Actavis generic WAS the brand; it was only marketed for Janssen by Actavis. It doesn’t make sense for you to try to get the “Actavis generic because it IS the brand. Moreover, that marketing deal has expired.
Perhaps something else has changed for you — are you taking an additional medication now? Are you getting less sleep? Have you changed your diet?
These are all questions you might ask.
Bottom line: Concerta is still Concerta. It has not changed. It cannot change. That is the FDA-approved brand, and it’s been the same for at least 15 years.
Good luck sorting this out.
Gina
Regarding getting the brand at formulary/generic prices… When I don’t make progress directly with the insurance company, I can sometimes get more traction by contacting my HR department directly. They seem to be able to get around some of the barriers I can’t.
Hi Valerie,
Thanks for sharing that tip. I’m glad it works for you.
My hesitation, for some, is that an employee’s ADHD has not been disclosed. And that could put employment in jeopardy.
I think I’d also be concerned even if the Rx was for a child.
People carry around so many misperceptions and judgments about ADHD.
But this is a judgment call. Some companies are better than others. Sounds like you have a good one. Good for you!
g
First of all, I am so grateful for the information you presented on this page and how updated you have kept it. My daughter was recently diagnosed with ADHD and prescribed Concerta 18 mg. The CVS pharmacist assured me that the Trigan generic was exactly the same as Concerta so (based on the $150+ price savings) I went for it. Something didn’t feel right as my doctor has written brand only on the prescription, so I came online to look it up and found this site and others about the issues with off-brand Concerta.
Reached out to my doctor and now we are in the process of trying to get the insurance company to waive the fee that is inflating my copay because of the brand name. Has any one has success with this?
I also am stuck with these pills as the pharmacy refuses to take them back. Just looked at them and noticed that of the 30 pills, 15 (or 50% of them) did not have the drill hole. Where can I find information that shows they are supposed to have the drill hole so I can bring them back to the pharmacy?
Hi Michelle,
I’m glad you found my blog. No one else is writing about this.
CVS is the worst. The very worst.
Trigen has recalled the 36 mg generic Concerta, as I mentioned in the post. Here is the FDA report: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=162135
But I’m not sure that means much for your 18 mg.
I would not be optimistic on getting your money back. But if your physician truly did write “dispense as written,” I’m not sure that you, the consumer, can override that. No matter what the deceptive pharmacist tells the consumer.
You might have luck escalating it to your health insurance carrier. I wouldn’t bother with CVS.
You can print my blog post showing the information on the drill holes. (The company claims that the coating dissolves once ingested, and that the holes are underneath. I say, “prove it.”)
To learn how you might get the brand at a “formulary” price, see section 4 in the post. Much depends on the terms of your insurance policy.
Good luck!
Gina
I just came online to see if anyone else was having the kinds of problems I’ve been having since my pharmacy started giving me “round” pills instead of the capsules everyone was so used to seeing. This new medication has been about as effective as a Tic-Tac and now I’m beginning to experience severe stomach pain (not too different from labor pains) in my upper stomach and left side. I’m very thankful that I found this site, as I will no longer allow them to give me this generic. I still haven’t found anything that worked as good as the Corepharma generic I used to get. Pharmacists swear up and down the generics are all the same, but anyone who’s experienced their normal medication made by a variety of different manufacturers knows that that’s a ridiculous lie. I just can’t get over the fact that we have to pay (a lot sometimes) to figure out which ones work and which ones are worthless.
Dear Beth,
I agree. It’s nuts. This ever-changing roulette wheel of medications.
I’m glad this post provided validation for you.
Stand your ground!
best,
Gina
For those of you dealing with CVS Caremark and long term mail order prescriptions – my plan now allows the same mail order price for purchasing a 90 day supply directly from our CVS pharmacy at Target. (I assume a stand alone CVS would be the same, but we don’t have any near here.)
This was not in any of my plan’s documentation – I heard about it from my pediatrician who had others who were able to do this. The first time the pharmacy couldn’t confirm anything about pricing until after they processed the full prescription, so I just kept my fingers crossed.
This has been a huge improvement for us. The mail order was a huge stress, especially as we also had substitutions and ridiculous mess due to tiny misses on the scripts. (In NY State they can only fill 30 days for a stimulant unless Code B is written on the script. That was my favorite, esp since they charged the full 90 day price. After getting the med for a couple years, I’d think they would know it was a “long term” Rx, which is what the code means, and do better follow-up with the doctor.)
It is worth checking your Target or CVS and see if they’ve been able to do long term fills for others. I’ve found our local Target pharmacy to be very helpful. It’s easy to tell their hands are tied in some areas, but they do what they can.
Thanks Gina for all the info. 🙂 We actually have a DAW script from our doc for my daughter because we did the Concerta generics early on and they didn’t work. But we pay the brand charge for it. And, our mail order via insurance is CVS caremark so no hope of getting the good stuff. So our insurance is okay, as long as they authorize it again this year, but we were hoping a good generic was available to lower costs a bit. We’ve been through a few and Concerta seems to work well for a while. As long as it does, we’ll bite the bullet. But I’m going to keep an eye on your blog now that I’ve found it!!
You’re welcome, Don!
You know, you CAN get the brand Concerta from CVS/Caremark.
In our case, though, it involved reading them the riot act (and public shaming on facebook!)
I would allow a buffer, though. Your insurance company can tell you how you can allow for getting the mail-order Rx started without risking running out.
It might involve picking up an extra interim Rx at the local drugstore.
And when you send in the Rx, make sure everything is written EXACTLY right. And attach a brief but clear note.
Hopefully, I have created a big enough stink on this issue that it won’t be as difficult for you. Hopefully.:-)
G
P.S. Don – it might be worth checking into Aptensio, a new methylphenidate formulation.
There are probably some huge discount coupons at the mfr’s website.
It might not work as well as Concerta. It might work better. You won’t know until it’s tried.
https://www.medscape.com/viewarticle/881844
g
So with the patent expiration and Actavis out of production, we don’t have any option other than brand? Any idea on impax yet?
Hi Don,
Well, you don’t have any other option if you want Concerta.
It might be worth trying the other new generics. I haven’t heard word about the Impax product.
Otherwise, maybe you missed this part of my post:
4. If I prefer brand Concerta to a new generic, what are my options?
Much will depend on your insurance coverage. Many insurers require policyholders to accept a generic if available. Here are some options:
1. Call your pharmacy fulfillment company and ask the price for the generic and the brand.
Also learn the price for home-delivery, typically a 60- to 90-day supply that is cheaper than the monthly cost if purchased at the local drugs store. Yes, you CAN order stimulants via home-delivery. I write about it here: Tip: Home Delivery of Stimulant Medications
2. If the brand is affordable:
Ask your prescriber to request an “exception” based on medical necessity.
A doctor can request by letter that the plan cover the medicine “by exception.” Even though the medicine is not on the plan’s formulary, the physician contends that another medicine will not work as effectively for you. For example, you are allergic to the other medicines on the formulary.
Unfortunately, sometimes it’s necessary to try the generic first. But if the previous Concerta generics have been tried, to poor effect, mention that.
Also explain if other stimulant medications were not satisfactory, including those in the same class as Concerta (methylphenidate products such as Ritalin, Quillivant, Daytrana, etc.) and the amphetamine class (Vyvanse, Adderall, Dexedrine, etc.) . Assuming, of course, that others had been tried before settling on Concerta; it might be that another medication will work better.
3. If the brand cost is prohibitive:
Check to see if you qualify for financial assistance from Concerta’s manufacturer:
You can also look for the best price available at GoodRX
So my kids have been on the Mallinckrodt Concerta for years and it works for them. We recently switched doctors, learned of the “generic” inequalities and switched to the Actavis (alza). It does not work for my children. All of their teachers called me the week I switched them to voice concerns over increased behavior problems, failing test, and increased impulsive behavior. So we have switched back to the Mallinckrodt, thankfully I had some extra. My concern is if they do d/c the Mallinckrodt, what will be our options.
Hi Amy,
How frustrating!
Yes, I’ve noted that a few times: Even though the Concerta generics don’t perform as well as the brand Concerta, they still might work better than Concerta for some people.
That doesn’t mean these generics shouldn’t have been downgraded. They weren’t enough like Concerta to force consumers to accept the generics as substitutions (as many insurance policies require).
What that means is that these people do best with a different release “profile.”
I’m not sure what Mallinckrodt’s plans are going forward. Last I heard, the company had defied the FDA’s order.
For now, you could try finding a pharmacy that has a supply. Typically, the home-delivery pharmacies have the largest supplies.
Beyond that, at least you know your children do well on methylphenidate. So there are lots of options, including:
Ritalin, Ritalin LA, Concerta, Aptensio, Daytrana, QuilliChew, Quillivant.
I’ve heard some ADHD pharma experts explain that the Mallinckrodt generic for Concerta works essentially the same as Ritalin LA. So, maybe that would be a place to start.
I hope this helps. Good luck!
Gina
I don’t why this just dawned on me, but I decided to use my stand alone pulse oximeter and my phone to test my bpm while on this “medication”. Every time I try it, it makes me so sleepy and sedated. So at hour 3, my oxygen is normal, but my pulse is ranging between 64-70, which is a low resting heart rate for me. (Also considering I take Wellbutrin XL, too.) I’m usually in the 90s. This is a bit unusual, I’d be curious what other people’s results are on trigen.
Hi Jane,
It will be difficult to tease out what is the Trigen effect for you and what is the Trigen effect coupled with Wellbutrin XL.
As for the “sleepy and sedated” feeling, is it possible that you are sleep deprived? If so, the stimulant might be helping you to notice and to relax.
g
I’ve taken Wellbutrin for years, Concerta was added about 6 months ago after a proper adult adhd diagnosis. Trigen’s version is noticeably different and the sedation feeling is quite strong. It’s not relaxing, it’s putting me to sleep!
I have regular vital sign checks at my monthly appointments and they’ve been consistent, with a slight increase in bpm since adding Concerta. So that’s why I find it so odd that this imposter is making me tired and lowering my heart rate. (although that’s not necessarily a bad thing, my husband said, “your heart rate has never been that low, it’s a miracle!” ha)
I had a physical two months ago and my labs were normal. Sleep deprivation isn’t an issue, I get 7-9 hours and am pretty persnickety about my sleep schedule.
The only thing that has changed is the addition of this new pill. I have an appointment this week, so we’ll see what my Doctor says. (sorry for the life story)
And btw, I checked the 90 day supply of brand Concerta and it’s significantly cheaper, so thank you for that tip! 🙂
All the best,
Jane
Hi Jane,
Well, if you didn’t have this phenomenon, all things being equal, on brand Concerta and Wellbutrin XL, that certainly doesn’t sound promising for continuing the generic.
It’s still possible, I suppose, that the dose is actually higher than with the Concerta, so it could be “zombie effect” that often comes with too-high a dosage of methylphenidate (e.g. Ritalin, Concerta, etc.).
But who the heck knows. So many variables.
I’m glad you found a cheaper supply of brand Concerta!
g
I got stuck with Trigen after using the good generic by Actavis. It has been very inconsistent and wears off at about 5.5 hours. It’s just a typical osmotic release pill, nothing like OROS. I cut one open, I was expecting to find a note saying, “gotcha!”. Lol. I haven’t been able to concentrate long with this form and went ahead and complained to medwatch and my doctor. Glad I’m not the only one with problems regarding this generic. My insurance will pay for the brand, but it’s a $50 copay. I may try generic focalin xr. Anyways, here’s a picture of the inside of an 18 mg pill. Seems to me abusers could easily abuse this, so there’s that aspect to be concerned about as well. http://imgur.com/geZuvc6
Haha! Gotcha!
Yes, Jane, good point about the abuse potential.
It might be that brand-Concerta mail-order, a 90-day supply, will be cheaper than the $50 co-pay each month.
Thanks for filing the MedWatch complaint. Consumers need to protect ourselves these days; no one’s doing it for us.
g
I found the dye info for Impax under their inactive ingredients: http://documents.impaxlabs.com/methylphenidate/pi.pdf. Doesn’t *appear* to have unnatural dyes.
Hi Adam,
Thanks for the link! I’ll add it.
That is a lot of text! I searched for “dye” and “color” and found nothing. When I searched for “inactive ingredients”, I found this:
Inactive Ingredients: ammonium hydroxide, cetyl
alcohol, ethylcellulose, ferrosoferric oxide,
hypromellose, lactose monohydrate, magnesium
stearate, n-butyl alcohol, polyethylene glycol,
povidone, propylene glycol, shellac, sodium
lauryl sulfate, titanium dioxide, and triethyl citrate.
The 18 mg tablet also contains the following
additional inert ingredient: yellow iron oxide; and
the 54 mg tablet also contains the following
additional inert ingredients: red iron oxide and
yellow iron oxide.
Thanks again.
Gina
Wow! Wow! Wow! I asked my son’s teacher if he could have a snack around 2:00 pm as he was losing his concentration in school. His latest prescription medicine has been changed to Trigen Lab generic and thanks to this article, I believe that is the problem! His pills used to be yellow, oval, and had ALZA stamped on them. Stupid me, I just trusted these round pills would work the same as the oval. NOPE!
I called the pharmacist at our CVS. He is a really great guy and we have always loved his service. He told me that he has the original medicine on the shelf, but CVS has instructed him to let it expire, he is not allowed to distribute it to anyone. He told me he has had other customers call to complain about Trigen, and he has tried to raise a voice, but to deaf ears. I am FURIOUS with CVS. What is the matter with these companies? Do robots run the pharmaceutical world? (My child also needs an epinephrine shot with him at all times. That is another tragic story (Epi-Pen) we had to deal with. We now carry Auvi-Q. )
Thank you for all your research and information.
HI JoAnne,
I am SO HAPPY that you found my post. Obviously, I don’t do this for the money. I do it because real lives hang in the balance.
Your son has a vigilant and smart momma! Kudos.
If you can, try Walgreen’s. It has a better track record than CVS.
(The very idea, having it on the shelf and not dispensing it…argh.)
It has been explained to me that pharmacies make more money on the generics than the brands. That might have something to do with it.
But also, some insurance policies make the generic price very attractive — and the brand prohibitive.
Still, it’s worth looking into the brand price for Concerta.
If it’s unaffordable, you might want to see if you financially qualify for the Concerta assistance program: http://www.janssenprescriptionassistance.com/concerta-cost-assistance
I’ll be writing soon about three new stimulant formulations. One is also methylphenidate, as is Concerta. The new brands are more competitive and have generous savings programs.
Stay tuned.
g
God bless ya! Thank you!
Gina –
As I understand it, the FDA initiated withdrawal proceedings for both the KU/Lannett and Mallinckrodt versions, but they’re stuck in administrative legal proceedings.
I thought you might find this GAO report interesting. Note that Concerta (methylphenidate ER) is not on the list of non-biological complex drugs that the FDA is focusing its attention.
https://www.gao.gov/assets/690/689047.pdf
Oh, thanks, Stu. Very interesting.
It’s definitely been a problem for the FDA, these complex drugs/complex delivery systems. I’m sure the FDA is getting squeezed from both sides. And so are the consumers!
g
Very glad that I stumbled across this blog. After seeing the drill hole comparison picture above, I decided to take a look at the Methylphenidate ER tablets (Trigen) in my prescription. Lo and behold, I noticed that a sizeable quantity of tablets had no obvious drill hole (I checked both sides). The tablets that did have a drill hole, had it in wildly varying locations (some very far from center).
Thankfully, I checked my new formulary (UHC) and Concerta (brand) is listed as tier I, while Concerta generics are listed at tier III with possible policy exclusion! Who knows if this will change, though…
Hi SC,
I’m glad you found my blog, too.
So you noticed irregular holes in the Trigen generic, too? The photo in the blog post is from the Mylan generic.
g
Recently my mail order pharmacy, optumRX/ Future Scripts switched to Trigen’s generic Concerta. It is not the same. It’s very weak and wears off after a few hours. I’ve called to complain to OptumRX pharmacy but ultimately it made no difference. OptumRX was adamant that it is the same drug and that all drugs effect people differently. I don’t understand their last response because regardless of how drugs effect others, I’m calling about the difference in drugs by manufacturers. I filed a complaint with the FDA.
I won’t mail order again because once they send you Trigen (which I’ve never received in the past) you’re stuck with it. No returns. No local pharmacy to go back to.
I’m sorry that happened to you, Angela.
It’s unbelievable that pharmacists lie so commonly on the issue of generics. There is definitely a conflict-of-interest here. Shameful.
The other way around it is for your doctor to stipulate “no substitutions.” And then you pay for brand.
Our recent experience with Caremark/CVS was horrendous, including delaying the prescription fill for THREE WEEKS. I think they were stalling for time, because they weren’t even carrying brand Concerta. (Not enough profit margin.)
Thanks for filing the complaint.
g
My daughter was just prescribed generic Concerta 27mg. I filled the prescription at CVS and sure enough, got the dreaded Trigen.
She’s 17 years old and has never taken Concerta before. (Newly-diagnosed with ADHD.)
Should I have her take it? Suggestions and/or recommendations of what to do? I’m leaning towards having her take it given there is no comparison for us, but if it doesn’t work how do I know it’s the dosage, the generic or the delivery system?
Thank you for your suggestions and guidance!
My daughter was just prescribed generic Concerta 27mg. I filled the prescription at CVS and sure enough, got the dreaded Trigen.
She’s 17 years old and has never taken Concerta before. (Newly-diagnosed with ADHD.)
Should I have her take it? Suggestions and/or recommendations of what to do? I’m leaning towards having her take it given there is no comparison for us, but if it doesn’t work how do I know it’s the dosage, the generic or the delivery system?
Hi Deb,
Much depends on your daughter.
If she has a poor reaction to the Trigen generic, will she likely become opposed to trying another Rx? If so, then no, it’s not worth the risk.
Also, does she have an important test or event this week? If so, I might wait until the weekend.
Otherwise, your strategy seems sound. If you don’t want to wait for all it will require to get a new script, get it filled (CVS might not even have in stock the brand Concerta…if you have the option, Walgreen’s might be better bet).
Good luck!
Gina
Regarding the Mylan generic and the missing laser-drilled holes – I think they may be on the other side of the pill. I saw a friends 27mg Mylan generics, and some of the meds were drilled on the labeled side and some on the blank side. The hole on the labeled side was very difficult to see – my friend couldn’t see it even after I pointed it out. On her 27mg ones, it was right next to the start of the 7 on the label. If I hadn’t picked up a pill with the hole on the labeled side first, I’m sure I wouldn’t have found it either – I would have assumed they should just all be easy to see on the unlabeled side.
Hi Valerie,
Maybe that’s the case, but the person who sent it to me is a highly competent psychiatric nurse. I think she would have looked closely.
At any rate, the lack of uniformity still seems a problem.
g
Brand and generics are NOT NOT NOT the same. I tried a generic of the antidepressant Pristiq and became suicidal.
With generic Adderall, I have neuropathy.
Generic medications MAY be a good rung in some instances. But when one is taking meds that affect emotional health, especially, it is important to have someone you know to check in with. And to make sure your doc wants to stay connected and is willing to switch back to brand if you have a reaction/shift/side effect. People die messing around with these meds. I know I am sensitive to additives and will not ever give generics another try.
So true.
g
Careful! That illustration appears to be the one for CONCERTA compared to plain Ritalin, NOT something from an actual rigorous study of Trigen. Sneaky to put “Methylphenidate ER” (which, technically, both Trigen and Concerta are, even though this is very obviously the exact chart that you can find with “Concerta” in that spot if you do a Google image search.) We saw that same chart cut-and-pasted into the Mallinkcrodt and Kremers generics that the FDA pulled AB status from previously. You may want to update your article. (see this link for reference: https://church4everychild.org/2014/02/23/why-your-kids-concerta-hasnt-been-working-lately/ )
Hello Joshua,
I’m not sure what you want me to be “Careful!” about. I find your point confusing.
That illustration is straight from the Trigen insert.
https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=c45dc1de-adfa-4b3c-a7dc-cffbc8eac74f&type=display
Welcome to the dicey world of generics.
I co-led the effort to have the FDA downgrade the generics that you mention, in that post from 2014.
g
I mean that that chart is NOT from a study of Trigen, even though it appears on their fact sheet. It is clearly a copy of the same chart in Concerta’s (section 12.3) https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=1a88218c-5b18-4220-8f56-526de1a276cd&type=display
Oddly the Concerta sheet has a lower quality version of the illustration, but if you look at the table underneath it, and compare it with the one from Trigen, it is clear that there is no new data: Trigen is presenting Concerta’s data as though it applies to Trigen’s product, using vague phrases to exploit loopholes.
You say of the chart that “It purports to compare the Trigen generic Concerta to generic Ritalin (Methylphenidate)” while what it is actually comparing is the brand-name Concerta to generic Ritalin. That chart makes sense in Concerta’s pamphlet, but in Trigen’s it’s even more misleading than you’re indicating. Hence my caution to you.
Yes, Joshua. That’s what I mean! That’s how they do it! The generic manufacturers don’t have to show that the medication works as well as the brand. They don’t have to give new data. They can use the brand’s data.
I use the word “purport” (appear or claim to be or do something, especially falsely; profess) because I find it a very sneaky smoke-and-mirrors process. One that practically begs exploitation.
CASE IN POINT: When my husband’s Concerta Rx was recently filled with the Trigen generic, I called the mail-order pharmacist at CVS-Caremark to complain; the physician had written (as always), “OROS only.” “This Trigen generics are clearly not OROS,” I said.
Pharmacist: “Oh, but I did call the company and they said it is IS OROS. It is the osmotic system.”
Me: “Did you also ask the fox how well he’s been guarding the henhouse?”
Pharmacist: “huh?”
Me: “If the company said it is OROS, the company lied to you. Did you read the product insert?”
Pharmacist: “Yes, and it says osmotic; that’s OROS.”
Me: “No. No, it’s not.”
But okay, Joshua, yes, I see where you got confused, and I re-wrote to flesh out the issue a bit more. If I went into detail on all of these issues, though, no one would read the entire post and get the most important information 🙂
Here’s the re-write:
CONSIDER THIS ILLUSTRATION, below, also from the Trigen product insert. It purports to compare the Trigen generic Concerta to generic Ritalin (Methylphenidate). I say “purports” because if you didn’t know better, you might think that the “methylphehnidate HCI Extended-Release tablet” in this caseis the Trigen generic. Which means you might conclude that the Trigen generic Concerta is superior to generic Ritalin—in the same way that brand Concerta is superior to genetic Ritalin, at least insofar as its “profile” (how the medication is released over time). Note the “peaks and valleys” over the first 12 hours; generic Ritalin is obviously more of a “roller coaster”.
Here’s the thing: Trigen simply lifted this illustration from the Concerta product insert. That graph compares brand Concerta to generic Ritalin. It has nothing to do with the Trigen generic.
To go into more detail risks boring you to tears. Suffice it to say, these generic manufacturers put all their resources into exploiting FDA loopholes when it comes to novel delivery systems such as OROS. The previously downgraded generics made a cynical play, and they were shut down. But only after much tumult in real people’s lives. Let’s hope more people are aware now and, if their “Concerta” stops working, they’ll know where to look first.
_____
I hope that seems more clear.
tx
g
Hi Gina,
Found an article on Wikipedia that pulls information from legit medical journals and gives a list of all drugs on the market with the OROS technology. It also has an interesting animation of what the inside of the Janssen/Alza pill looks like.
Since this delivery system is proprietary, it seems to me that it is not even possible for another company to ever make a real generic equivalent unless Janssen is willing to sell or license their technology. They hold the patent. How annoying! Spent hours on the phone the other day between Dr. and insurance battling against Trigen.
Maybe this list of OROS drugs will help people argue that it’s not the same. Forget the chemical part – it’s not delivering the med the same way into the bloodstream. Seems like it’s entering on and off instead of evenly throughout the day.
Good luck to everyone and big thanks for the information!!
Nancy
Oops forgot the link!!
https://en.m.wikipedia.org/wiki/Osmotic_controlled-release_oral_delivery_system
Hi Nancy,
Thanks!
Actually, the OROS technology is owned by Alza, the company that developed it, not Janssen.
Janssen licenses the OROS technology in Concerta.
This is a very sophisticated delivery system. It’s not going to be easily replicated, especially without infringing on copyright.
tx
g
Gina, how does this news affect us here in Canada, if at all?
Hi Brian,
I’m pretty sure that these generic Concerta products are not yet on the Canadian market. It’s a different approval process.
Yet, there have long been complaints about the “Concerta” pills available to Canadians.
CADDAC’s director, Heidi Bernhardt, wrote this piece for ADHD Roller Coaster blog readers a few yearsago:
https://adhdrollercoaster.org/adhd-news-and-research/generic-concerta-in-canada-parallel-problems/
And I’ve not seen an updated to this post from CADDAC/CADDRA. I’ll ask Heidi.
http://caddacblog.ca/?p=714
Thanks,
Gina
I will ask my pharmacist to see if I can get the KU generic methylphenidate. Thanks for the heads up.
Good luck, Stu!
Hi Stu,
Please tell me what you found out regarding the Kremer brand. I just tried to fill my daughter’s Kremer brand only to be told that CVS can longer get it. We have tried 2 other brands, but 1 brand did nothing and the latest one from CVS wore off after only 6 hours and also didn’t perform as well.
I did find out from a different pharmacy that Lannett has taken over Kremers so I’m trying to get the Lannett brand. The online catalog for Lannett shows the same picture as the Kremers brand. But any insight is welcome. Thank you in advance.
Hi Sue,
Kremers-Urban is a division of Lannett. That’s not new.
The Kremers-Urban generic for Concerta was downgraded by the FDA several years ago. Because it was found not as effective as Concerta, it could no longer be substituted for brand. Without that status, there might not be enough market for it and so it’s no longer available.
I haven’t been able to find documentation of this. The FDA asked for the two generic manufacturers (Kremers-Urban and Mallinckrodt) to voluntarily remove their downgraded generics. Mallinckrodt filed suit against the FDA, but I think that suit was tossed out by a Maryland judge. I thought Kremers-Urban had agreed to withdraw the product. Perhaps they did so after all supply was distributed and sold.
Why are you so intent on your child having this generic? Did you find that it worked remarkably better than brand?
Gina
Hi Gina,
Thanks for your response. She did not respond well to the brand name so the doctor put her on the Kremers with significant improvement. I’m at a loss now if the Kremers (or Lannett) brand is not available. It’s always a struggle to find the right med and we finally found a solution with the Kremers. After reading everything I can get my hands on, I can confirm that the latest round of pills is Trigen from CVS, and like everyone else, it is not working well and wears off quickly.
Perhaps I need to try her again with brand name Concerta and get a fresh look at how she reacts as she has grown quite a bit since the last try with brand name.
Any suggestions are welcome. Thank you!
Hi Sue,
It looks like your best option will be a trial of other options, including brand Concerta, as you say.
A friend of mine has been on Concerta for 15 years but recently made the switch to Vyvanse and reports more energy, clearer though, better ability to slog through difficult projects, etc.
It might not be the case for your daughter, that brand Concerta or Vyvanse will work for her. But it seems your best option.
There are also three other new stimulants on the market, most of which offer a discount. One of them is methylphenidate-based: Aptensio XR. http://www.aptensioxr.com/about-aptensio
There is a pretty sweet savings deal, which is great as medication trials can get very expensive! http://www.aptensioxr.com/copay
Changing medication isn’t always easy. It should be done in a very methodical way so as not to risk work/school going off the rails. On the weekends, if at all possible.
If it were me, I’d probably try to first track down as much of the KU generic as possible. Perhaps a 90-day supply via mail-order, if your pharmacy benefit includes that. The mail-order pharmacies have larger stocks, so they might be more likely to still have some of the KU supply.
Then I’d try some of the other choices on the weekend.
Good luck!
g
Hi Sue –
I spoke with my CVS pharmacist in Northern Illinois. CVS no longer carries the KU/Lannett methylphenidate ER, but is carrying the Mallinckrodt methylphenidate ER. After taking branded Concerta for many years, I’ve had no issues taking either the KU/Lannett or Mallinckrodt versions.
AS you know, both drugs are no longer “AB-rated” to branded Concerta. I’ve asked my doctor to write “methylphenidate ER (Mallinckrodt)” on my script, and my CVS pharmacist filled it. I suggest asking your CVS pharmacist if he/she has the Mallinckrodt version on the shelf.
Good luck!
– Stu
Thanks, Stu. So, Mallinckrodt still refuses to withdraw its inferior generic.
Are you paying brand or generic price, though?
tx
g
I’m paying the generic price.