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06/22/2021

Sun Pharma reaches patent litigation settlement for generic Revlimid

Sun Pharma will be able to manufacture and sell a limited quantity of generic lenalidomide capsules after March 2022, as well as an unlimited quantity beginning Jan. 31, 2026.
Sandra Levy
Senior Editor
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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.

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