Monday 8 December, 2008

Fenofibrate (Antara) Casules 130 and 43 mg: Lupin challenged formulation patent

Innovator Oscient Pharma and Ethypharm SA, have confirmed the receipt of Paragraph IV certification notice letter from Lupin Limited, wherein, Lupin has submitted ANDA with the USFDA for ANTARA® (fenofibrate) capsules, 130 and 43 mg. Lupin has filed para IV against following Orange Book listed patent:

US7101574 (Expiry: Aug 20, 2020): which covers a pharmaceutical composition in the form of granules, wherein each granule comprises a neutral microgranule 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.

Innovator Oscient and Ethypharm have 45 days to initiate a patent infringement lawsuit against Lupin to block Lupin’s ANDA approval process for 30 months.

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