Watson Pharmaceuticals sued in connection with filing ANDA for generic equivalent of Trilipix

May 3 2010

Watson Pharmaceuticals, Inc. (NYSE: WPI) today confirmed that its subsidiary, Watson Laboratories, Inc. - Florida, has been sued by Abbott Laboratories and Fournier Laboratories Ireland Ltd. in connection with the filing of Watson's Abbreviated New Drug Application (ANDA) for choline fenofibrate delayed-release capsules in the 45 mg and 135 mg strengths. Watson's ANDA is for a generic equivalent of Abbott's Trilipix® product. The suits were filed on April 27, 2010 and April 29, 2010 in the United States District Court for the District of New Jersey and Southern District of Florida, respectively.

Pursuant to the Hatch-Waxman Act, Watson previously notified Abbott and Fournier that Watson's ANDA contains a paragraph IV certification asserting that U.S. Patent No. 7,259,186 is invalid, unenforceable and /or will not be infringed by the commercial manufacture, use or sale of the drug products described in Watson's ANDA.  Abbott and Fournier'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.  

Trilipix® (choline fenofibrate) delayed-release capsules are indicated for the treatment of high triglyceride and cholesterol levels.  For the twelve months ending February 2010, Trilipix® had total U.S. sales of approximately $161 million according to IMS Health data.