Watson confirms patent challenge for Trilipix generic

MORRISTOWN, N.J. Drug maker Abbott has sued a Watson Pharmaceuticals subsidiary over its attempt to market a generic cholesterol drug, Watson said Friday.

Watson said Abbott sued Watson Laboratories Inc. – Florida over its regulatory approval application for choline fenofibrate delayed-release capsules in the 45-mg and 135-mg strengths. The drug is a generic version of Abbott’s Trilipix, used to treat high cholesterol and triglyceride levels.

Watson included in its application a Paragraph IV certification, a legal assertion stating that Abbott’s patent for Trilipix is invalid, unenforceable or won’t be infringed by a generic version of the drug. In response, under the terms of the Hatch-Waxman Act of 1984, Abbott sued Watson in the U.S. District Courts for the District of New Jersey and the Southern District of Florida. The suit requires the Food and Drug Administration to put a stay on approval for two and a half years or until the two companies reach a settlement or Watson wins the case.

Trilipix had sales of $161 million during the 12-month period ended in February, according to IMS Health. The patent covering the drug that Watson seeks to invalidate, U.S. Patent No. 7,259,186, expires in 2025, according to FDA records.