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Sun Pharma among others faces ban to sale generic version of Eloxatin
Our Bureau, Mumbai | Monday, April 26, 2010, 08:00 Hrs  [IST]

Sun Pharmaceuticals and few leading pharma majors have received blow as they lost the case for selling infringing generic version of Eloxatin (oxaliplatin) of Sanofi-aventis in the US. The US District Court of New Jersey has order to cease selling of eloxatin from June 30, 2010. This order clarifies the previously announced Eloxatin settlement agreements requiring all defendant generic manufacturers to cease sales of their infringing products as of that date – and resolves the litigation over certain formulations of oxaliplatin in the US District Court for the District of New Jersey and the US District Court for the District of Columbia.

This announcement follows a recent set of settlement agreements between sanofi-aventis and Debiopharm (licensor of the involved patent rights) and certain generic manufacturers, namely Teva Pharmaceuticals USA, Inc., Fresenius Kabi (formerly Dabur), Sandoz, Mayne/Hospira, MN/Par and Actavis, some of which are selling infringing generic oxaliplatin products.

Under the terms of these settlement agreements, the generic manufacturers would cease selling their infringing generic oxaliplatin products in the US from June 30, 2010, to August 9, 2012, at which time the generic manufacturers would be authorized to sell generic oxaliplatin products under a license, before expiry of the patents at issue. The rest of the settlement provisions are confidential. Moreover, all of the settlement provisions, including the dates noted above, are subject to contingencies.

The lawsuits relate to the quality and formulation of oxaliplatin, available in the US under the brand name Eloxatin. The settlement agreements are subject to review by the Federal Trade Commission, the US Department of Justice and the Attorney General for the State of Michigan.

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