Bristol-Myers Squibb Co.'s unit Celgene Corp. settled a patent infringement lawsuit with India's Cipla Ltd. concerning its cancer drug Revlimid.
Summit, N.J.-based Celgene — which was acquired by Bristol-Myers in November 2019 — will grant Cipla a license to certain of its patents on Revlimid, or lenalidomide.
After March 2022, when patents on Revlimid are set to expire, the Indian drugmaker will be allowed to manufacture and sell certain volume-limited amounts of a generic version of Revlimid in the U.S. starting on a confidential date.
Cipla is restricted from producing generic lenalidomide more than the volume percentages agreed between the parties for each consecutive 12-month period following the volume-limited entry date until Jan. 31, 2026. The company will be licensed to manufacture and sell an unlimited quantity of the generic drug in the U.S. after Jan. 31, 2026.
Cipla's authority to market the drug in the U.S. will be contingent upon its receipt of approval of an abbreviated new drug application.
Revlimid in combination with dexamethasone is approved in the U.S. to treat a type of blood cancer known as multiple myeloma.