PARSIPPANY, N.J., Oct. 17, 2011 /PRNewswire/ -- Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market Risedronate Sodium Delayed-release Tablets, 35 mg. Watson's Risedronate Sodium Delayed-release Tablets are a generic version of Warner Chilcott (US), LLC's Atelvia(TM) delayed-release tablets. Atelvia(TM) is indicated for the treatment of postmenopausal osteoporosis.
Warner Chilcott (US), LLC and Warner Chilcott Company, LLC filed suit against Watson on October 12, 2011 in the United States District Court for the District of New Jersey seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 7,645,459 and 7,645,460. 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 that Warner Chilcott 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.
Based on available information, Watson believes it may be a "first applicant" to file an ANDA for the generic version of Atelvia(TM) and, should its ANDA be approved, may be entitled to 180 days of generic market exclusivity.For the twelve months ending August 31, 2011, Atelvia(TM) had total U.S. sales of approximately $17 million according to IMS Health data. About Watson Pharmaceuticals, Inc. Watson Pharmaceuticals, Inc. is a leading integrated global pharmaceutical company. The Company is engaged in the development and distribution of generic pharmaceuticals and specialized branded pharmaceutical products focused on Urology and Women's Health. Watson has operations in many of the world's established and growing international markets.