Watson Pharmaceuticals Inc. recently confirmed that it has filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) to market the generic version of Bayer’s oral contraceptive, Beyaz.
Beyaz is indicated for the prevention of pregnancy, treatment of symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception, treatment of moderate acne for women aged 14 years and above (only if the patient desires an oral contraceptive for birth control) and to raise folate levels in women who choose to use an oral contraceptive for contraception.
This move from Watson Pharma has drawn legal tensions as Bayer along with Merck & Cie filed a lawsuit against Watson Pharma in the United States District Court for the District of Delaware following the ANDA filing. The companies are seeking to prevent the generic company from commercializing its product prior to patent expiry. Since the lawsuit was filed under the provisions of the Hatch-Waxman Act, the FDA cannot approve Watson Pharma's ANDA until 30 months from the date of ANDA filing or until court order, whichever occurs earlier.
Watson Pharma believes that it may be the first company to file an ANDA for the generic version of Beyaz, and if its application is approved, it will be entitled to 180 days of generic market exclusivity.
According to IMS Health, the US sales of Beyaz amounted to $97 million, for the twelve months ended December 31, 2011.
We note that it has been an eventful year so far at Watson Pharma. Last week, the company reached a settlement with Janssen Pharmaceuticals, Inc., a subsidiary of Johnson & Johnson , on a patent litigation related to Watson Pharma's generic version of Janssen’s birth control pill, Ortho Tri-Cyclen Lo.
According to the settlement agreement, Janssen will manufacture and supply an authorized generic version of Ortho Tri-Cyclen Lo to Watson Pharma, which will in turn market and distribute the authorized generic from December 31, 2015 onwards or earlier under certain circumstances.