Watson Laboratories files raloxifene hydrochloride tablet ANDA

May 6 2010

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 a raloxifene hydrochloride tablet.  Watson's raloxifene hydrochloride tablet is a generic version of Eli Lilly's EVISTA®.  EVISTA ® is indicated for the treatment and prevention of osteoporosis in postmenopausal women, for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis, and for the reduction in the risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer.

Eli Lilly and Company filed suit against Watson on May 3, 2010 in the United States District Court for the Southern District of Indiana seeking to prevent Watson from commercializing its product prior to the expiration of U.S. Patent Nos. 6,458,811, 6,797,719 and 6,894,064.  Lilly's suit 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 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, 2010, EVISTA ® had total U.S. sales of approximately $690 million according to IMS Health data.