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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