September 17, 2020: “Bristol Myers Squibb announced that its wholly owned subsidiary, Celgene, and Dr. Reddy’s Laboratories, Ltd. and Dr. Reddy’s Laboratories, Inc. (collectively, DRL) have settled their litigation related to patents for REVLIMID® (lenalidomide).
As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin DRL from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below.
In settlement of all outstanding claims in the litigation, Celgene has agreed to provide DRL with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the U.S. beginning some time after the March 2022 volume-limited license date that Celgene previously provided to Natco.
The specific volume-limited license date and percentages agreed-upon with DRL were not disclosed and are confidential.
In addition, Celgene has agreed to provide DRL with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the U.S. beginning no earlier than January 31, 2026.
REVLIMID®
In the U.S., REVLIMID® (lenalidomide) 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 indicated for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
REVLIMID® is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.
Limitations of Use: REVLIMID® is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.”
https://news.bms.com/news/corporate-financial/2020/Bristol-Myers-Squibb-Announces-Settlement-of-U.S.-Patent-Litigation-for-REVLIMID-lenalidomide-With-Dr.-Reddys/default.aspx
