Udayavni Special

Sun Pharma settles patent litigation with Celgene Corporation for cancer drug Revlimid


PTI, Jun 22, 2021, 11:08 AM IST

New Delhi: Drug major Sun Pharma on Tuesday said the company has reached an agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding generic version of Revlimid (lenalidomide capsules) in the US.

Revlimid is used in the treatment of cancer.

“Sun Pharmaceutical Industries along with one of its wholly-owned subsidiaries today announced that they have reached an agreement with Celgene Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an abbreviated new drug application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US,” Sun Pharma said in a regulatory filing.

Pursuant to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene”s patents required to manufacture and sell certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022, the company added. This will be subjected to USFDA approval.

In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.

Sun Pharma said 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 company added.

The agreement is subject to customary regulatory approvals.

Shares of Sun Pharma were trading 0.19 per cent lower at Rs 669.95 apiece on BSE. P

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