Watson Seeks FDA Approval For Generic Version Of Beyaz

Date : 02/10/2012 @ 4:55PM
Source : Dow Jones News
Stock : Actavis, Inc. (WPI)
Quote : 85.73  0.0 (0.00%) @ 2:05AM

Watson Seeks FDA Approval For Generic Version Of Beyaz

Watson (NYSE:WPI)
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Watson Pharmaceuticals Inc. (WPI) has filed an abbreviated new-drug application with the U.S. Food and Drug Administration for its generic version of Bayer HealthCare Pharmaceuticals Inc.'s Beyaz oral contraceptive.

Bayer HealthCare, along with parent Bayer Pharma AG (BAYRY, BAYN.XE), and Merck KGaA (MKGAY, MRK.XE) subsidiary Merck & Cie filed a lawsuit against Watson in a Delaware district court Friday to prevent Watson from launching a generic version of Beyaz prior to the expiration of its patent.

Watson said it believes it may be a "first applicant" to file an abbreviated new-drug application for a generic version of Beyaz and may be entitled to 180 days of market exclusivity, if the application is approved.

Watson has seen strong sales of its generics as health-care companies and consumers reduce spending on health-related products and services. Watson also has a stable of branded drugs focused on urology and women's health.

Last month, the company said its results for 2011 were stronger than expected as it saw strong growth of its generics business, especially from new generic Lipitor sales.

Watson shares rose 15 cents to $58.14 in after-hours trading. The stock is down 11% in the past three months.

-By Nathalie Tadena, Dow Jones Newswires; 212-416-3287; nathalie.tadena@dowjones.com

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