Sun Pharma settles patent dispute with Celgene over generic Revlimid
Mumbai: Sun Pharmaceutical Industries Limited 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.
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.
Sun Pharma manufactures and markets a large basket of pharmaceutical formulations covering a broad spectrum of chronic and acute therapies.
It includes generics, branded generics, specialty, complex or difficult to make technology-intensive products, over-the-counter (OTC), antiretrovirals (ARVs), Active Pharmaceutical Ingredients (APIs) and Intermediates.