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with the introduction of at least four 12 who-the-heck-knows more Concerta generics, I have written a new post (since outdated given the news above): Authorized Generic Concerta Update.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).
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
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,
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.
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