Oscient Pharmaceuticals, a commercial-stage pharmaceutical company, has announced that the company, its wholly owned subsidiary Guardian II Acquisition, and its licensor, Ethypharm, have filed a lawsuit against Lupin Limited and its subsidiary Lupin Pharmaceuticals in the US District Court of Maryland for the infringement of a US patent which covers Antara capsules.
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Oscient filed this lawsuit under the Hatch-Waxman Act in response to the Paragraph IV certification notice received by the company from Lupin advising the company of the filing of an abbreviated new drug application by Lupin with the FDA to market a generic version of Antara prior to the expiry of the patent in August 2020.
Oscient said that it is committed to protecting its intellectual property rights relating to Antara through patent expiration. 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 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 US until it receives final approval.
In December 2008, Oscient announced that the company and Ethypharm had received notice of a Paragraph IV certification on behalf of Lupin, advising of the submission of an abbreviated new drug application with the FDA for Antara.
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