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news.Abbott Laboratories and Fournier Laboratories Ireland have sued Watson Laboratories, a subsidiary of Watson Pharmaceuticals, in connection with the filing of Watson's abbreviated new drug application (ANDA) for Choline Fenofibrate delayed-release capsules in the 45mg and 135 mg strengths.
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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 US District Court for the District of New Jersey and Southern District of Florida, respectively.
Trilipix (choline fenofibrate) delayed-release capsules are indicated for the treatment of high triglyceride and cholesterol levels.
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.
Pursuant to the Hatch-Waxman Act, Watson previously notified Abbott and Fournier that its ANDA contains a paragraph IV certification asserting that US 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.