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Sun Pharma Announces US FDA Approval for Generic Lenalidomide Capsules

Feb 10, 2023, 02:27 pm

Sun Pharmaceutical Industries Limited including its subsidiaries and/or associate companies), today announced that one of its wholly owned subsidiaries has received final approval from US FDA 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.

In June 2021, Sun Pharma had entered into a settlement with Celgene Corporation (Celgene) 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.

About Sun Pharmaceutical Industries Limited

Sun Pharma is the world's fourth largest specialty generic pharmaceutical company and India's largest pharmaceutical company. A vertically integrated business and a skilled team enables it to deliver high-quality products, trusted by customers and patients in over 100 countries across the world, at affordable prices. Its global presence is supported by manufacturing facilities spread across 6 continents and approved by multiple regulatory agencies, coupled with a multi-cultural workforce comprising over 50 nationalities. Sun Pharma fosters excellence through innovation supported by strong R &D capabilities across multiple R&D centers, with investments of approximately 6% of annual revenues in R&D.

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