Watson confirms Beyaz patent challenge

PARSIPPANY, N.J. — A subsidiary of Watson Pharmaceuticals is seeking approval for its version of an oral contraceptive from the Food and Drug Administration.

Watson Labs has filed an abbreviated new drug application with the FDA and is seeing to market drospirenone and ethinyl estradiol and levomefolate calcium tablets in the 3-mg/0.02-mg/0.451-mg strength and levomefolate calcium tablets in the 0.451-mg strength, a generic version of Bayer HealthCare Pharmaceuticals' Beyaz.

In related news, Watson also confirmed that Bayer, along with Bayer Pharma AG, and Merck & Cie filed suit against Watson on Feb. 10 in the U.S. District Court for the District of Delaware seeking to prevent Watson from commercializing the product prior to the expiration of U.S. patent No. 6,441,168. The drug maker said it believes it may be a a "first applicant" to file an ANDA for the generic version of Beyaz and may be entitled to 180 days of generic market exclusivity (should its ANDA be approved).

Beyaz had total U.S. sales of approximately $97 million for the 12 months ended Dec. 31, 2011, according to IMS Health data.


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