Consumer Alert: Three New Concerta Generics as Janssen/Actavis Deal Ends

three new Concerta generics as Janssen-Actavis-Teva marketing deal ends

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with the introduction of at least four 12 who-the-heck-knows more Concerta generics, I have written a new post (since outdated given the news above): Authorized Generic Concerta Update.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

[advertising; not endorsement] [advertising; not endorsement]

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:

  1. Trigen Laboratories
  2. Mylan (of Epi-Pen infamy)
  3. Impax Laboratories
  4. 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:

Concerta generics
Brand Concerta

A 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.

Concerta generics Trigen
Trigen’s generic for Concerta

There 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:

  1. Present the pharmacy manager with the FDA Drug Safety Report. If you print it, note my yellow highlights and replicate them on the photocopy.
  2. 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.)
  3. 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. 
  4. Ask your physician to indicate “no substitutions” on the Rx script.
  5. Complain to your health insurance carrier.
  6. 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:

  1. Trigen generic Concerta, and
  2. Brand Concerta.

But no, this graph compares the profiles of

  1. Brand Concerta (Methylphenidate HCI Extended Release Tablets)
  2. 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.

concerta generic

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.

Concerta generics

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

About The Author

289 thoughts on “Consumer Alert: Three New Concerta Generics as Janssen/Actavis Deal Ends”

  1. Maribel Bernardino

    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!

    1. 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. Concerta brand and authorized generic will say

      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

  2. 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.

    1. 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!

  3. 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.” 🙂

  4. 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!

    1. 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

    2. 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!

  5. 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.

    1. 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

  6. 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.

  7. 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

    1. 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

  8. 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!

    1. 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

    2. 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.

    3. 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

  9. 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?

    1. 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.

    2. ALWAYS check your pills before you pay for them. You typically cannot return them once you pay for them and especially after you leave the store.
    3. Ask your pharmacy to carry the Watson/Actavis/OROS authorized generic (same as brand).
    4. If the pharmacy refuses, call other pharmacies. Independent stories might be more helpful. Also, there are the big-box stores, such as Costco (where you don’t need a membership to use the pharmacy) or Target.
    5. Present the pharmacy manager with this latest FDA Drug Safety Report. If you print it, note my yellow highlights and replicate them on the photocopy.
    6. Contact your mail-order pharmacy (if applicable): If your health insurance includes a mail-order option (typically, 60- or 90-day supply), ask if that pharmacy carries the OROS “authorized” Concerta. If not, ask how much more the brand Concerta will be. (Tip: Home Delivery of Stimulant Medications.)
    7. Complain to your health insurance carrier.
    8. 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 brand or authorized generic. (Be prepared to pay the brand price, though.)
    9. Ask your physician to write “OROS only” on the prescription; Watson is in the process of changing names to Actavis, so it’s likely that confusion will result if either name is used instead of OROS (the technology that makes Concerta unique).[Update: Teva has since bought Actavis!]
    10. Ask your physician to indicate “no substitutions” on the Rx script if the OROS generic is unavailable and you are willing to pay for the brand.
    11. Good luck!

      Gina

  10. 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.

    1. 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

  11. 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.

    1. 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

    2. 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?

    3. 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).

  12. 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.

    1. 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/

  13. 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!

    1. 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

  14. ADHDNoGenerics

    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!

    1. 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

  15. 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!

    1. 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!

  16. 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.

    1. 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!

    2. 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?

    3. 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

  17. 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!

    1. 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.

  18. 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.

    1. 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

  19. Anne-Marie Turnier, MD

    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!

    1. 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

  20. Kegan Morrison, C.E.

    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…

    1. 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

  21. 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.

    1. Good for you, Mike! Great follow through — and thinking ahead to prevent this happening again! (we hope).

      Kudos!
      g

  22. 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

    1. 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/

  23. 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.

    1. 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!

  24. 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.

    1. 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.

    2. 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

  25. 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. >:(

    1. 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

  26. Kristen Hurwitz

    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

    1. 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

  27. Kristen Hurwitz

    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.

  28. 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.

    1. 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.

  29. Kristen Hurwitz

    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.

    1. 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

  30. 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.

    1. 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

  31. Kristen Hurwitz

    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.

    1. 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

  32. 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

    1. 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

  33. Charles Maas, MD

    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.

    1. 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

  34. Miriam Calvo-Gil

    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.

    1. 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!

    2. 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!!!

    3. 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

    4. 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.

    5. 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

  35. 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.

    1. 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

  36. 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!

    1. 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

  37. 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.

  38. 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.

    1. 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

  39. 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.

    1. 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

  40. 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.

    1. 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

  41. 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!

    1. 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

  42. 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.

    1. 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

    1. 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

    1. 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

  43. 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.

  44. 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.

    1. 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

    1. 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

  45. 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?

    1. 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

  46. 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 ;.

  47. 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.

    1. 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

  48. Sheila Howard

    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.

    1. 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

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