Benzinga | Sep 17, 2020 06:59AM EDT

Bristol Myers Squibb Announces Settlement Of US Patent Litigation For REVLIMID (lenalidomide) With Dr. Reddy's

Dr. Reddy's licensed to sell volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date after the March 2022 date previously granted to Natco

Dr. Reddy's also licensed to sell generic lenalidomide in the U.S. without volume limitation beginning on January 31, 2026

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

Bristol Myers Squibb (NYSE:BMY) today 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(r) (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.