Watson Pharmaceuticals files application for generic SEASONIQUE

Mar 6 2008

Watson Pharmaceuticals, Inc. has confirmed that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market its levonorgestrel and ethinyl estradiol (0.15 mg/0.03 mg) extended-cycle oral contraceptive product, prior to the expiration of patents owned by Duramed Pharmaceuticals, Inc., a subsidiary of Barr Pharmaceuticals, Inc.

Watson's levonorgestrel and ethinyl estradiol product is a generic version of Barr's SEASONIQUE(R).

On January 23, 2008 pursuant to the Hatch-Waxman Act, Watson notified Barr that it had filed an ANDA with a paragraph IV certification with the FDA for a generic version of SEASONIQUE(R) asserting that the SEASONIQUE(R) patent is invalid or not infringed. Based on available information, Watson believes it may be the first applicant to file an ANDA for SEASONIQUE(R) and, should its product be approved, may be entitled to 180 days of generic market exclusivity.