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Watson Confirms Lo Loestrin® Fe Patent Challenge
Date:5/18/2012

PARSIPPANY, N.J., May 18, 2012 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc., filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Norethindrone Acetate/Ethinyl Estradiol and Ethinyl Estradiol and Ferrous Fumarate Tablets,1 mg/0.01 mg and 0.01 mg and 75 mg. Watson's ANDA product is a generic version of Warner Chilcott Company LLC's Lo Loestrin® Fe which is indicated for use by women to prevent pregnancy.

Warner Chilcott Company, LLC filed suit against Watson on May 16, 2012, in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its ANDA product prior to the expiration of U.S. Patent Nos. 5,552,394 and 7,704,984. The lawsuit was filed under the provisions of the Hatch-Waxman Act, resulting in a stay of final FDA approval of Watson's ANDA for up to 30 months from the date the plaintiff received notice of Watson's ANDA filing or until final resolution of the matter before the court, whichever occurs sooner, subject to any other exclusivities.

For the twelve months ending March 31, 2012, Lo Loestrin® Fe had total U.S. sales of approximately $86 million according to IMS Health data.

About Watson Pharmaceuticals, Inc.Watson Pharmaceuticals, Inc. is an integrated global specialty pharmaceutical company. The Company is engaged in the development, manufacturing, marketing and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. The Company is also developing biosimilar products in Women's Health and Oncology. Additionally, Watson distributes generic and branded pharmaceuticals through its Anda, Inc. distribution business. Watson has opera
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SOURCE Watson Pharmaceuticals, Inc.
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