Sun Pharma has reached an agreement with Celgene to resolve a patent litigation regarding the submission of an ANDA for a generic version of Revlimid (lenalidomide) capsules.
Pursuant to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell (subject to Food and Drug Administration approval) certain limited quantity of generic lenalidomide capsules in the United States, beginning on a confidential date that is sometime after March 2022. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the U.S. beginning Jan. 31, 2026.
As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid patents, will be dismissed. Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals.