Watson seeks FDA approval to market generic Beyaz

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Drospirenone and Ethinyl Estradiol and Levomefolate Calcium Tablets, 3.0 mg/0.02 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg. Watson's ANDA product is a generic version of Bayer HealthCare Pharmaceuticals Inc.'s Beyaz®. Beyaz® is an oral contraceptive indicated for use by women to prevent pregnancy, treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception, treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control, and raise folate levels in women who choose to use an oral contraceptive for contraception.

Bayer HealthCare Pharmaceuticals Inc., Bayer Pharma AG, and Merck & Cie filed suit against Watson on February 10, 2012, in the United States District Court for the District of Delaware seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent No. 6,441,168.  The lawsuit was filed under the 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 until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of Beyaz® and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.

For the twelve months ending December 31, 2011, Beyaz® had total U.S. sales of approximately $97 million according to IMS Health data.