Sun Pharma bags USFDA okay for generic lenalidomide capsules

Mumbai: Pharma major, Sun Pharmaceutical Industries Limited, has announced that one of its wholly owned subsidiaries has received final approval from US Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for generic lenalidomide Capsules, 5mg, 10mg, 15mg, 25mg and tentative approval for 2.5mg, 20mg.

The respective product approval is based on Revlimid Capsules, 5mg, 10mg, 15mg, 25mg and 2.5mg, 20mg as a reference product.

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In June 2021, Sun Pharma had entered into a settlement with Celgene Corporation to resolve the patent litigation regarding Sun Pharma’s generic lenalidomide capsules. Pursuant to the terms of this settlement, Celgene granted Sun Pharma a license to Celgene’s patents required to manufacture and sell certain limited quantity of generic lenalidomide capsules in the US beginning sometime after March 2022. In addition, the license allows Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

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Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra. The company manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies. It includes generics, branded generics, specialty, complex or difficult-to-make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs), and Intermediates.