Bristol Myers' Celgene, Cipla Settle U.S. Patent Litigation On Lenalidomide

(RTTNews) - Bristol Myers Squibb (BMY) said Friday that its subsidiary, Celgene, and Cipla Limited have settled their litigation regarding to patents for Revlimid or lenalidomide.

As part of the settlement, the companies will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Cipla from marketing generic lenalidomide before the expiration of the patents-in-suit.

Under the settlement, Cipla is licensed to sell volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date after March 2022

Cipla is also licensed to sell generic lenalidomide in the U.S. without volume limitation no earlier than January 31, 2026

The earliest licensed entry of any generic lenalidomide in the U.S. continues to be March 2022, based on settlements reached.

In the U.S., Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma.

Revlimid as a single agent is also indicated as a maintenance therapy in patients with multiple myeloma following autologous hematopoietic stem cell transplant. Revlimid is approved in the U.S. for the treatment of patients with mantle cell lymphoma whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.