Here at the ADHD Roller Coaster, I’ve long cautioned about generic medications for ADHD. Articles include Update on Generic Rx: Approach with Caution and Consumer Reports on Autos? Yes. ADHD Medications? No!
I’m now hearing that Concerta is recently available in a new generic form in the United States. (A generic has been available in Canada for some time, but it is a different type of generic.)
The question: Does this generic perform as reliably as Concerta? The answer: Yes. We know this because this particular Concerta generic is the brand; it is only marketed as a generic. That makes it an authorized-generic — not a standard generic.
You can read updated details about generic Concerta in this post- last updated 12/2022: Authorized Generic Concerta Update; please subscribe to this blog to stay apprised of developments.
Searching for Clarity
The pharmaceutical industry swims with lingo: co-licensed product, single-source generic, authorized generic, bioequivalent and clinically equivalent, and so forth.
As I sought clarity on this issue, I spoke with pharmacists and the Concerta manufacturer’s scientific liaison. It all left me thirsting for straight talk with no tricky qualifiers.
Even more confusing: Reading first-person reports in online forums. For example, there is a marked difference between Canada’s generic Concerta and that in the U.S.. Yet, forum participants seldom specify where they live. Presumably, that’s because most don’t realize there is a difference between the two countries’ generic versions of Concerta.
An Authorized Generic IS the Brand
For this post, I’m addressing only the U.S. generic for Concerta.
It’s not a” true” generic—that is, a medication that is produced to be a reasonable facsimile of a brand. It is an “authorized” generic. In other words, this is the brand marketed as a generic.
On the label, you’ll see methylphenidate hydrochloride extended-release tablets. It is a co-licensed product by exclusive agreement — that is, a deal between the original manufacturer (Ortho-McNeil) and the pharmaceutical marketing arm of Watson Laboratories.
Both brand-name Concerta and this authorized generic are manufactured in the same plant, said a spokesperson for manufacturer Ortho-McNeil by phone. And, this authorized generic is both bioequivalent and clinically equivalent.
Does that mean it’s the exact same medication? Yes, according to an FTC report on generic drugs, it is the same product (FTC Report Examines How Authorized Generics Affect the Pharmaceutical Market.
An authorized generic is a lower-cost, generic-label version of a brand-name drug that is already sold by the same manufacturer.
The Hatch-Waxman Act is designed to ease the introduction of generic drugs by, in certain circumstances, granting a 180-day period of marketing exclusivity to the first generic competitor of a brand-name drug, known as a “first-filer.”
During that exclusivity period, no other generic company can receive FDA-approval to sell its product. However, this marketing exclusivity period does not prevent brand-name companies from introducing their own authorized generic versions.
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When Patents Expire, Deals Are Sometimes Struck
According to a press release (no longer available online) from Watson Laboratories, the first patent for Concerta is set to expire in 2018. Thanks to a legal settlement between two pharmaceutical manufacturers, however, a generic version became available much earlier, in May 2011.
Due to the settlement, Watson Laboratories is allowed to sell an “authorized generic” version of Concerta through 2014. [Update 2019: Generic company Teva is now distributing the authorized Concerta generic, but the company and Concerta manufacturer Janssen have made public no deals about their agreement.]
Here is the apparent bottom line: The original manufacturer, Ortho-McNeil. supplies Watson with brand-name Concerta tablets; Watson packages and sells the tablets as an authorized generic drug.
That means the generic version is exactly the brand-name Conceta in every way, except in price. For example, our mail-order pharmacy was charging $120 for a 90-day supply of Concerta; for this authorized-generic version, the charge is $20. Quite a savings!
[Update: Other “true” Concerta generics entered the scene later, and that’s when all the troubles started.]