Sun Pharmaceutical Industries announced that one of its wholly owned subsidiaries received final FDA approval for its Abbreviated New Drug Application (ANDA) for generic lenalidomide capsules, 5mg, 10mg, 15mg, and 25mg, as well as tentative approval for 2.5mg and 20mg. The respective product approval is based on the reference product Revlimid Capsules, 5mg, 10mg, 15mg, 25mg, and 2.5mg, 20mg. Sun Pharma reached a settlement with Celgene Corporation (Celgene) in June 2021 to resolve the patent litigation involving Sun Pharma’s generic lenalidomide capsules.
According to the terms of the agreement, Celgene granted Sun Pharma a licence to Celgene’s patents necessary to manufacture and sell a limited quantity of generic lenalidomide capsules in the United States beginning after March 2022. Furthermore, the licence allows Sun Pharma to manufacture and sell an unlimited number of generic lenalidomide capsules in the United States beginning January 31, 2026.