FDAnews
www.fdanews.com/articles/174703-celgene-settles-with-natco-over-revlimid-patent-dispute
correct_handshake.gif

Celgene Settles With Natco Over Revlimid Patent Dispute

January 4, 2016

Natco will be able to sell a generic version of Revlimid in the U.S. before the expiration of the final patent covering the multiple myeloma drug as the result of a lawsuit settlement with Celgene.

Under the settlement, Celgene will grant Natco a volume-limited license to sell its generic version of Revlimid in the U.S. in March 2022. The volume limitation will increase every 12 months until March 2025. Starting Jan. 31, 2026, Natco will be able to manufacture and sell an unlimited quantity of generic lenalidomide in the U.S. — more than a year before the final patent expires in April 2027.

The case was filed in the U.S. District Court for the District of New Jersey. Natco’s U.S. partner, Arrow International, now part of Allergan, also was named in the suit.

During its third quarter earnings update last month, Celgene said it expects net 2015 sales of Revlimid to be about $5.8 billion.