Oscient Pharmaceuticals, along with its wholly owned subsidiary Guardian II Acquisition and its licensor, Ethypharm, has filed a lawsuit against Lupin Limited and Lupin Pharmaceuticals in the U.S. District Court for the District of Maryland for infringing a patent for the lipid-lowering drug Antara.
The Waltham, Mass.-based Oscient said it filed this lawsuit under the Hatch-Waxman Act in response to notification from Lupin on Dec. 3, 2008, of its abbreviated new drug application with the FDA to market a generic version of Antara (fenofibrate) prior to the expiration of U.S. Patent No. 7,101,574 patent in August 2020.
The company said that in accordance with the Hatch-Waxman Act, “final FDA approval of the generic drug product will be stayed until the earlier of 30 months from the date of receipt of the paragraph IV certification notice or a court decision finding that the '574 patent is either invalid, unenforceable or not infringed by Lupin's proposed generic product. Should Lupin receive tentative approval of its generic version of Antara from the FDA, it cannot lawfully launch its generic version of Antara in the U.S. until it receives final approval.”
Antara capsules are indicated for the adjunct treatment of hypercholesterolemia and hypertriglyceridemia in combination with diet.