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Generic Version of Beyaz Sparks Patent Lawsuit

Filed February 13th, 2012 Julie

Watson Laboratories, Inc., a subsidiary of Watson Pharmaceuticals, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA), asking for approval to market the generic version of Bayer HealthCare Pharmaceutical Inc.’s Beyaz oral contraceptive.
Bayer Healthcare, along with Bayer Pharma, and Merck’s subsidiary Merck & Cie filed a lawsuit against Watson on Friday in a Delaware district court in an effort to prevent Watson from launching the generic birth control pill onto the market before the expiration of its patent. The suit was filed under provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of
Watson’s ANDA for up to 30 months from the date the plaintiffs received notice of Watson’s ANDA filing or under the matter can be resolved definitively, whichever occurs first.

Watson says it is the first company to file an ANDA for a generic version of Beyaz, which would entitle them to 180 days of market exclusivity if the application is approved.

In addition to being an oral contraceptive, Beyaz is prescribed to treat premenstrual dysphoric disorder (PMDD), and moderate acne in females age 14 and older.

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