Industry

USFDA gives nod for generic Lenalidomide capsules

Sun Pharma entered into a settlement with Celgene Corporation (Celgene) to resolve the patent litigation regarding Sun Pharma’s generic lenalidomide capsules.

The Health Master

February 10, 2023

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Last Updated on October 10, 2024 by The Health Master

Sun Pharmaceutical Industries announced that one of its wholly owned subsidiaries has received final approval from the USFDA for its Abbreviated New Drug Application (ANDA) for generic lenalidomide capsules (5 mg, 10 mg, 15 mg, 25 mg) and tentative approval for 2.5 mg, 20 mg.

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

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In June 2021, Sun Pharma 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.

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