Indian multinational pharmaceutical company Sun Pharma has reached an agreement with US pharmaceutical company Celgene Corporation (Celgene), resolving the patent litigation regarding submission of new drug ANDA for generic versions of oral cancer drug Revlimid in the US.
In accordance with the terms of the settlement, Celgene will permit Sun Pharma a license to its patents needed to manufacture and distribute certain quantities of generic lenalidomide capsules (Revlimid) in the US. Sun Pharma will be permitted the license from a confidential date, which is confirmed to be some time after March 2022, subject to USFDA approval. From January 2026, the license will also give Sun Pharma the authorisation to manufacture and distribute an unlimited quantity of generic lenalidomide capsules in the US.
As of the result of the settlement, Sun Pharma has stated that all Hatch-Waxman litigation between the two companies, regarding Revlimid patents, will be disregarded.
