Cipla reaches patent litigation settlement with Celgene on generic Revlimid

Cipla has reached a settlement with Celgene, and its subsidiary Bristol Myers Squibb relating to patents for Revlimid (lenalidomide). As part of the settlement, the parties will file consent judgments with the U.S.District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement.

Celgene has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after March 2022. For each consecutive 12 month period (or part thereof) following the volume-limited entry date until Jan. 31, 2026, the volume of generic lenalidomide sold by Cipla cannot exceed certain agreed upon percentages. The specific volume-limited license date and percentages agreed upon with Cipla are confidential.

Celgene also has agreed to provide Cipla with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than Jan. 31, 2026. Cipla’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an ANDA.

Arunesh Verma, CEO, Cipla North America said, “This is an important step forward for us and is in line with our pursuit of improving access to high quality life-saving treatments.”