Mylan Obtains Injunction Preventing FDA from Approving Any Other Generic Norvasc Until April 13
Mylan Laboratories announced this morning that the U.S. District Court for the District of Columbia has enjoined the FDA from approving any other ANDAs for generic Norvasc (amlodipine besylate) until at least April 13, 2007. Mylan launched its generic Norvasc last week and, with the exception of Pfizer's authorized generic, currently has the only generic on the market.
Mylan was the first generic drug maker to file an ANDA for generic Norvasc, and is therefore entitled to a 180-day generic exclusivity period. However, FDA's policy for pre-Medicare Modernization Act ("MMA") ANDAs (like Mylan's) is that the 180-day exclusivity period cannot extend beyond patent expiration. Pfizer's patent on Norvasc expired on Sunday, and therefore without the injunction Mylan's 180-day exclusivity period might have been cut short. (The MMA introduced numerous 180-day exclusivity "forfeiture provisions," one of which is that 180-day exclusivity ends upon patent expiration. Since Mylan's ANDA was filed before December 8, 2003, however, the MMA does not apply.)
Mylan filed its Complaint against the FDA and Emergency Application for a Temporary Restraining Order and/or Preliminary Injunction yesterday, and the district court ruled on it the same day. According to the district court's Order, the "FDA will now solicit the views of other interested parties on this matter by April 4, 2007 and will render an agency decision on April 11, 2007." The FDA is to notify the court of its decision no later than April 11 and is enjoined from taking final agency action "until April 13, 2007 at 5:00 pm to enable the court to rule formally on the plaintiff's application for a TRO."
Presumably, such interested parties include Apotex, Dr. Reddy's, Gedeon Richter USA, Kali Labs, Matrix, Roxane, Teva, and Watson, each of which has been granted tentative approval to market generic Norvasc and is awaiting only resolution of the exclusivity issues.
The other party with a huge stake in this case is Pfizer--the innovator who developed Norvasc and whose patent the Federal Circuit declared invalid last Thursday. Pfizer has 6 months of pediatric exclusivity on Norvasc and indicated last week that it will "pursue all available legal remedies" to protect that exclusivity.
This case is far from over. We'll post additional briefs and submissions as they become available.
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UPDATES:
- FDA Law Blog reports that Mylan filed a citizen petition with the FDA on Monday to enforce its 180-day exclusivity period.
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