Revlimid drug: Biocon enters patent litigation settlement with Celgene

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26 Aug, 2025 12:21

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Pharmaceutical giant Biocon has settled the suit through a confidential settlement agreement with Celgene Corporation relating to patents for generic Revlimid drug, the company said in an exchange filing.

Celgene Corporation earlier filed a complaint in the District of New Jersey, against Biocon over potential patent infringement by a potential generic drug created by Biocon. Meanwhile, Biocon had filed for an approval from the Food and Drug Administration (FDA).

“This is to inform you that Biocon Limited and its subsidiaries Biocon Pharma Limited and Biocon Pharma Inc. (“Biocon”) has entered into a confidential settlement agreement with Celgene Corporation (Celgene), a wholly owned subsidiary of Bristol Myers Squibb (NYSE: BMY), relating to patents for REVLIMID (lenalidomide),” Biocon said in the filing. Additional details regarding the settlement are confidential.

Revlimid is a blockbuster blood cancer drug with sales of $12.1 billion for BMS in 2020.

Celgene alleged that the Biocon’s Abbreviated New Drug Application (ANDA) for the generic version of Revlimid (lenalidomide capsules) in the US to engage in the commercial manufacture, use, sale, offer for sale, or importation into the US will be prior to the expiration of the patents Celgene holds and approval of the same would result in infringement.

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In June, Sun Pharma had entered into a settlement with Celgene to resolve a similar patent litigation. As per the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell certain limited quantities of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022. This will be subject 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.