Eli Lilly and Co. and FDA and Patent and Generic drugs and Health Care & Life Sciences and Pharmaceutical

Lilly sues to block copy of Evista osteoporosis drug

May 5, 2010

Eli Lilly and Co. sued Watson Pharmaceuticals Inc. to prevent the sale of a generic version of its osteoporosis drug Evista in the United States.

Watson, based in Corona, Calif., filed for U.S. Food and Drug Administration approval to sell a low-cost version of the Lilly medicine, which contains the active ingredient raloxifene hydrochloride. Indianapolis-based Lilly is seeking a court order that would block approval until three of its patents expire in 2017.

Evista is a bone-loss treatment first approved by regulators in 1997 and used to treat women after menopause. A study released last month indicated that raloxifene also may provide some protection against breast cancer in women. The drug generated $682.2 million in U.S. sales last year for Lilly, the company said Jan. 28.

In its FDA application, Watson contends the patents are invalid, unenforceable or not infringed, according to a complaint filed by Lilly on May 3 in federal court in Indianapolis.

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