You can read updated details about generic Concerta in this 12/12/13 post; please subscribe to this blog to stay apprised of developments.
After advising caution regarding generic medications for ADHD here and here, I’m now hearing that Concerta is recently available in a 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? Maybe. In fact, it might be the exact same medication.
The details are hard to come by in a field swimming with lingo: co-licensed product, single-source generic, authorized generic, bioequivalent and clinically equivalent. My conversations with pharmacists and the manufacturer’s scientific liaison leave me thirsting for straight talk with no tricky qualifiers. Internet searches and first-person reports in online forums are made murky by the apparently marked difference between Canada’s generic Concerta and that in the U.S.. (Forum participants seldom specify where they live, presumably because most don’t realize there is a difference between the two countries’ generic versions of Concerta.)
The U.S. generic for Concerta is 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 the so-called “authorized generic” are manufactured in the same plant, said the Ortho-McNeil spokesperson by phone. And, this authorized generic is both bioequivalent and clinically equivalent. Does that mean it’s the exact same medication? Yes, according to this FTC report on generic drugs, it is the same product:
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.
According to a press release 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.
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 a generic drug. That means the generic version is exactly like 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 if the results are the same.
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