Sun Pharma And Celegene Settle Patent Dispute Over Lenalidomide (Revlimid®)

Settling an over three old patent infringement dispute, Indian pharmaceutical major, Sun Pharmaceuticals and its subsidiary, including US subsidiary ("Sun"), has reached a settlement with Celgene Corporation ("Celgene"), a subsidiary of pharmaceutical major Bristol Myers Squibb (BMS), to resolve and settle the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid® (lenalidomide) capsules in the US: Celgene Corp. (Bristol Myers Squibb) v. Sun Pharma Case. Celgene sued Sun Pharma for patent infringement in 2018.

While the settlement terms, including exact dates and amount that can be manufactured/sold, has been kept confidential, what has been disclosed is that Celgene will grant Sun Pharma a license to manufacture and sell (subject to USFDA approval) generic lenalidomide capsules in the US (a) limited quantity sometime after March 2022; (b) unlimited quantity after Jan 2026. On the other hand, all