Sun Pharma, Celgene to settle patent row over anti-cancer drug

Sun Pharmaceutical Industries has reached an agreement with innovator Celgene Corporation, which is a Bristol Myers Squibb subsidiary, to resolve patent litigation pertaining to anti-cancer drug Revlimid (lenalidomide capsules) in the U.S.

Under the terms of the settlement, Celgene will grant Sun Pharma a licencse to its patents required to manufacture and sell, subject to USFDA approval, certain limited quantity of generic lenalidomide capsules in the U.S. beginning on a confidential date, sometime after March 2022.

Further, the licence will allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the U.S. beginning January 31, 2026. Sun Pharma said this on Tuesday while announcing that it has, along with one of its wholly owned subsidiaries, reached the agreement with Celgene to resolve the patent litigation regarding submission of an abbreviated new drug application (ANDA) for a generic version of Revlimid in the U.S.

Consequently, all Hatch-Waxman litigation between Sun Pharma and Celgene regarding the Revlimid patents will be dismissed. The agreement is subject to customary regulatory approvals, Sun Pharma said.

Natco Pharma and Dr.Reddy’s Laboratories are among a few companies that had in the past settled patent litigations over the drug indicated in the treatment of multiple myeloma.

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Printable version | Aug 1, 2021 1:22:46 AM |

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