Mylan Can Breathe Easy on Norvasc Until April 13

Mylan Laboratories (MYL) 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 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 Norvasc 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-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 in the absence of the injunction, the FDA could have approved other ANDAs for generic Norvasc.

According to the FDA website, such other ANDAs include those filed by Gedeon Richter USA and Matrix Labs. In addition, Apotex and Synthon are known to have filed ANDAs for generic Norvasc.

Mylan filed a Complaint (pdf file) and Emergency Application (pdf file) 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 (pdf file), 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."