Oscient Pharmaceuticals Corp. have filed a patent-infringement suit in Maryland district court against Lupin Pharmaceuticals Limited, based in India, for the cholesterol-fighting drug Antara (Generically known as Fenofibrate).
Oscient based in Waltham, Mass., said it received a certification notice from Lupin on Dec. 3 advising the company that Lupin would seek FDA approval to market a generic version of Antara prior to the drug’s patent expiration (US7101574) in 2020. US7101574 claims a pharmaceutical composition in the form of granules, wherein each granule comprises a neutral micro-granule on which is a composition comprising: micronized fenofibrate, a surfactant, and a binding cellulose derivative as a solubilization adjuvant, and wherein said fenofibrate is present in an amount greater than or equal to 60% by weight, relative to the weight of said pharmaceutical composition, and further wherein said binding cellulose derivative represents between 2 to 15% by weight, relative to the weight of said pharmaceutical composition.
A generic company needs to have either non-infringing composition of the claim or invalidate the claim to market the product in US.
