February 13, 2012 at 09:20:45 EST by Proactive Investors
Watson Pharmaceuticals (NYSE:WPI) said Friday that it has filed an abbreviated new drug application with the U.S. health regulator for drospirenone, the generic version of Bayer Healthcare's oral contraceptive Beyaz.
Watson said it believes it may be the first applicant to file for the generic version of Beyaz and, should its drug application be approved, may be entitled to 180 days of generic market exclusivity.
In addition, Bayer also announced that it filed a lawsuit against Watson in the U.S. District Court for the District of Delaware over the patent for Beyaz.
The lawsuit, filed under the provision of the Hatch-Waxman Act, seeks to prevent Watson from selling its product prior to the expiration of U.S. Patent No. 6,441,168.
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