Watson Pharmaceuticals, Inc, a leading specialty pharmaceutical company, has filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA) seeking approval to market its Drospirenone and Ethinyl Estradiol tablets (3.00 mg/0.03 mg) combination oral contraceptive product prior to the expiration of patents owned by Bayer HealthCare Pharmaceuticals, Inc. (Bayer).
Watson's Drospirenone and Ethinyl Estradiol product is a generic version of Bayer's Yasmin (drospirenone and ethinyl estradiol) tablet which is indicated for the prevention of pregnancy.
Bayer filed suit against Watson on April 18, 2008 in the US District Court, District of Southern New York seeking to prevent Watson from commercializing its product prior to the expiration of US patent number 5,569,652. Bayer's suit 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 or until final resolution of the matter before the court, whichever occurs sooner.