Sun Pharma announces settlement of patent litigation in US

Sun Pharmaceutical Industries today announced settlement of patent litigation for generic Revlimid (lenalidomide) in the US.

Sun Pharmaceutical Industries 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 Corporation, a wholly-owned subsidiary of Bristol Myers Squibb, will grant Sun Pharmaceutical Industries, a license to Celgene Corporation's patents required to manufacture and sell [subject to United States Food and Drug Administration (USFDA) 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 Pharmaceutical Industries to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning on 31 January 2026.

As a result of the settlement, all Hatch-Waxman litigation between Sun Pharmaceutical Industries and Celgene Corporation, regarding the Revlimid (lenalidomide capsules) patents, will be dismissed. As per the exchange filing on the bourses, additional details regarding the settlement are confidential and the agreement is subject to customary regulatory approvals.

Shares of Sun Pharmaceutical Industries are trading lower by 0.34% at Rs 669 on BSE. The stock hovered in the range of Rs 668.50 and Rs 679.60 so far.

The announcement was made before trading hours yesterday, 22 June 2021.

Sun Pharmaceutical Industries is the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company.

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