Friday, October 24, 2008

Novartis to Defend Mylan’s Paragraph IV for Fluvastatin

Swiss-drug major Novartis has filed a lawsuit in the US District Court for the District of New Jersey against Mylan Pharmaceuticals Inc. for infringement of Orange Book listed US Patent No. 5,354,772 (the ‘772 patent) for Lescol capsules, generically known as Fluvastatin Sodium. The infringement suit is result of Mylan’s submission of an abbreviated new drug application (ANDA) with paragraph IV certification for the Lescol capsules earlier in June 2008. Mylan believes that it is first to file ANDA for the product. Fluvastatin is indicated for the treatment of high cholesterol and had US market sales of approximately USD 60 million for the twelve months ending June 20, 2008 according to IMS Health.

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