As the FDA Generics Office Turns
By
Brian Orelli
July 1, 2008
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Normally, issuing final approvals for Abbreviated New Drug Applications (ANDAs) at the FDA is just another day on the job. But the ANDA granted to Teva Pharmaceuticals (Nasdaq: TEVA) yesterday for its generic version of Johnson & Johnson's (NYSE: JNJ) Risperdal must have stung just a little.
You see, the FDA doesn't think that Teva deserves the 180-day exclusive marketing period for challenging Johnson & Johnson's patent, but a court disagrees. The FDA has appealed that decision, but the court date isn't until the middle of September, so Teva will have the only ANDA approval at least until then. Mylan (NYSE: MYL), Par Pharmaceutical (NYSE: PRX), and Barr Pharmaceuticals (NYSE: BRL) are all rooting for the FDA, since they, among others, already have tentative approvals that would turn into final approvals if the 180-day exclusivity is overturned.
Teva won't quite have the generic market all to itself. Johnson & Johnson announced yesterday that it would launch an authorized generic of the drug. Authorized generics, especially of blockbuster drugs, have become common as a way for branded-drug makers to recoup some revenue after losing marketing exclusivity. This will also serve as way as to push the price of Teva's product down, which doesn't help Johnson & Johnson directly, but I'm sure it feels good to punish the competition a little.
The big question is how big an effect the availability of cheap generic versions of Risperdal will have on the sales of other atypical antipsychotics, like Eli Lilly's (NYSE: LLY) Zyprexa or AstraZeneca's (NYSE: AZN) Seroquel. Normally, a new generic treatment for a disease will cause a rush of switching from branded competitors to the new generic, but in the case of antipsychotics, I think the switching may be muted. Psychiatrists may be reluctant to switch schizophrenia or bipolar-disorder patients who are stable on their current medication just to save a few bucks.
The generic-drug world doesn't get much more dramatic than this. Stay tuned, Fools, I'm sure there's at least one more episode left.
More Foolish drama that's far from generic:
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