Sun Pharma gets US FDA nod for generic lenalidomide capsules

Sun Pharmaceutical Industries 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, 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.

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.