Sun Pharma announces settlement of patent litigation for Generic Revlimid in US

Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell a certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022.

Jun 22, 2021 09:06 IST India Infoline News Service

Sun Pharma
Sun Pharmaceutical Industries Limited, “Sun Pharma” and includes its subsidiaries and/or associate companies) along with one of its wholly-owned subsidiaries, today announced that they have reached an agreement with Celgene Corporation (Celgene), 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.

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 USFDA approval) certain limited quantity of generic lenalidomide capsules in the US 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 US beginning January 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.

At around 9.54 am, Sun Pharmaceuticals Industries Ltd was trading at Rs672.30 per piece up by Rs1.05 or 0.16% from its previous closing of Rs671.25 per piece on the BSE.

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