Victory! Concerta Generics Downgraded!

Concerta generics downgraded

The best news! The FDA announced today that the two approved generic versions of Concerta manufactured by Mallinckrodt Pharmaceuticals and Kudco have been downgraded.

It’s horrifying that so many people have already been adversely affected, and without warning—and their concerns dismissed by some pharmacists and even physicians.

“It’s the same as the brand,” some pharmacists said. “No, it’s not!” we said. And the FDA heard us.

ADHD Roller Coaster readers had much to do with that!  Many of you followed through by filing a complaint with the FDA’s MedWatch program, as I’ve encouraged repeatedly over the past year.

That form was NOT easy to complete, especially if your meds were underperforming! And I’m sure Dr. Kristen Stuppy, who blogs at Pediatric Partners, is celebrating. She has worked hard to publicize this issue, too.

Please note: A more recent post provides updates on this topic: Authorized-generic Concerta update  But you might want to first read the background info below.

Congrats and Hooray!

You can read the full press release below.  I’m pulling out this very practical point here for emphasis.

In short, this means:

  • The Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta.
  • If you take Concerta, it’s worth having a chat with your physician about this. Perhaps bring in a copy of this announcement, below or share the link to the post above: Authorized-generic Concerta update

Methylphenidate Hydrochloride Extended-Release Tablets (generic Concerta) made by Mallinckrodt and Kudco

[11-13-2014] FDA concerns about therapeutic equivalence with two generic versions of Concerta tablets (methylphenidate hydrochloride extended-release)

Based on an analysis of data, FDA has concerns about whether or not two approved generic versions of Concerta tablets (methylphenidate hydrochloride extended- release tablets), used to treat attention-deficit hyperactivity disorder in adults and children, are therapeutically equivalent to the brand-name drug. The two approved generic versions of Concerta are manufactured by Mallinckrodt Pharmaceuticals and Kudco Ireland Ltd.

FDA has not identified any serious safety concerns with these two generic products.  Patients should not make changes to their treatment except in consultation with their health care professional.

If you or your health care professional are concerned the drug product is not providing the desired effect and you do not know the manufacturer, contact the pharmacy where the prescription was filled to verify the product’s manufacturer.  If you, or those under your care, are taking the Mallinckrodt or Kudco products and have concerns about lack of desired effect during the dosing period, contact the prescribing health care provider to discuss whether or not a different drug product would be more appropriate.

FDA’s Scientific Evaluation of Generic Concerta Products

An analysis of adverse event reports, an internal FDA re-examination of previously submitted data, and FDA laboratory tests of products manufactured by Mallinckrodt and Kudco have raised concerns that the products may not produce the same therapeutic benefits for some patients as the brand-name product, Concerta, manufactured by Janssen Pharmaceuticals, Inc.  Janssen also manufactures an authorized Concerta generic, which is marketed by Actavis under a licensing agreement and is identical to Janssen’s Concerta.  FDA included the authorized generic in its analysis and found it to be bioequivalent to, and substitutable for, Concerta.  Apart from the Mallinckrodt, Kudco, and Actavis products, there are no other generics for Concerta.

Methylphenidate hydrochloride extended-release products approved as generics for Concerta are intended to release the drug in the body over a period of 10 to 12 hours. This should allow for a single-dose product that is consistent with the effect of a three times per day dose of immediate-release methylphenidate hydrochloride.

In some individuals, the Mallinckrodt and Kudco products may deliver drug in the body at a slower rate during the 7- to 12-hour range. The diminished release rate may result in patients not having the desired effect.

As a result, the FDA has changed the therapeutic equivalence (TE) rating for the Mallinckrodt and Kudco products from AB to BX. This means the Mallinckrodt and Kudco products are still approved and can be prescribed, but are no longer recommended as automatically substitutable at the pharmacy (or by a pharmacist) for Concerta.

Consequently, FDA has revised its draft guidance for industry for bioequivalence testing for methylphenidate hydrochloride extended-release tablets (Concerta). FDA has asked that within six months, Mallinckrodt and Kudco confirm the bioequivalence of their products using the revised bioequivalence standards, or voluntarily withdraw their products from the market.

FDA will continue to evaluate its testing and approval standards and bioequivalence guidances for other generic methylphenidate hydrochloride extended-release products and revise as needed.


41 thoughts on “Victory! Concerta Generics Downgraded!”

  1. Pingback: Top 10 Posts: ADHD Roller Coaster 2015 - ADHD Roller Coaster with Gina Pera

  2. I am another person that can attest to how ineffective the Mallinckrodt generic Concerta ER (54 mg) is.
    And- I Just received the Mallinckrodt Generic Concerta in the mail again. (April 30, 2015)

    After a conversation with a pharmacist from my mail order company 3 months ago, I thought this brand would not be the substitute any more.
    Of course, I called the mail order pharmacy when this new batch of the Mallinckrodt came. This pharmacist said I need to have my doctor write that a generic can not be substituted.
    What’s going on? Do I have any recourse with the new 90 day supply?

    1. Good question, Cathy.

      I’m not familiar enough with the legalities, especially as they might vary by state.

      But that pharmacist is wrong, that you are asking for brand when in fact there is an authorized generic available.

      I would go up the chain of command, perhaps going to your health insurance company.

      And fax them, if necessary, this post (which is more current that the “Victory!” post on which you comment):

      My sense is that this pharmacist hasn’t a clue, the mail-order pharmacy has no supply of the “authorized generic,” and they are just feeding you a line of bull.

      If you get the runaround, I would take it to Twitter. I’ve found some of these companies are much more responsive when these problems are aired publicly. 😉

      Good luck, and please keep us posted.

  3. I’m not sure if this was a victory. My doctor knew log ago that everything but the Watson rx were crap. Now that the others are pulled from the market, our copay has doubled in 2 months.

    I resent Watson for capitalizing on a sad situation and am angry that the FDA doesn’t do something to prevent price gouging when a ruling of theirs doesn’t become a windfall for others.

    Anyone ever tried Quillavent? They have a $20 or 30 copay program and I’d like to avoid giving another dime to the maker of Concerta after their recent price fixing.

    1. Hi Jennifer,

      I appreciate your frustration. It is not in the FDA’s charter, though, to regulate pricing of medications, and that’s probably a good thing for consumers, especially when it comes to the introduction of new and better medication.

      As for the makers of Concerta, I’m sorry but you have it entirely wrong. Janssen has not been doing any “price fixing.” The company that is marketing the authorized generic of Concerta, Actavis/Watson, is competing in the marketplace. That’s how capitalism works. With all its problems, it’s still better than countries such as UK and, heaven forbid, France, where adults with ADHD are typically left high and dry.

      Instead of blaming the FDA, I would look to your insurance company. Ultimately, they have aided and abetted pharmacies whose profit margin is larger on generics than brand. Sometimes insurance companies even make money on generics, because the co-pay is more than the medication costs at places such as Costco and Wal-Mart.

      And yes, it definitely was a victory. Read the posts from people here, people who did not know the Concerta generics weren’t truly “equivalent.”


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