Pharma major Sun Pharmaceutical Industries Ltd. on Tuesday said it along with one of its subsidiaries have reached an agreement with Celgene Corporation (Celgene) to resolve a patent litigation.
In a statement Sun Pharma said it along with its subsidiary has agreed 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.
As per the agreement, 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 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.
According to Sun Pharma, as a result of the settlement between Sun Pharma and Celgene under the US Hatch-Waxman Act, regarding the Revlimid patents, will be dismissed.
Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals, Sun Pharma said.