Celgene settles Revlimid patent litigation with Alvogen

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Summit-based Celgene Corp., Lotus Pharmaceutical Co., and Alvogen, headquartered in Pine Brook, (collectively, Alvogen) announced on Friday the settlement of their litigation relating to patents for Revlimid (lenalidomide).

The Business Wire reported that 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 Alvogen 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 said that it has agreed to provide Alvogen with a license to Celgene’s patents required to manufacture and sell certain volume-limited amounts of generic lenalidomide in the United States beginning on a confidential date that is some time after the March 2022 volume-limited license date that Celgene previously provided to Natco.

For each consecutive twelve-month period (or part thereof), following the volume-limited entry date until Jan. 31, 2026, the volume of generic lenalidomide sold by Alvogen cannot exceed certain agreed-upon percentages.

Although the agreed-upon percentages are confidential, they increase gradually each period to no more than a single-digit percentage in the final volume-limited period. In addition, Celgene has agreed to provide Alvogen with a license to Celgene’s patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning no earlier than Jan. 31, 2026.

Alvogen’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.