Watson Confirms Beyaz Patent Challenge

Watson Pharmaceuticals, Inc.

today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application 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.