- Lotus and Alvogen licensed to sell volume-limited amounts of generic lenalidomide in the U.S. beginning on a confidential date after the March 2022 date Celgene previously granted to Natco
- Alvogen 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
Oral oncology and specialty pharmaceutical Lotus Pharmaceutical Co., Ltd (“Lotus” or “the Company”, 1795:TT) and global pharmaceutical company Alvogen today announced the settlement of their litigation relating to patents for REVLIMID® (lenalidomide) with Celgene Corporation (NASDAQ: CELG)
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 Lotus and 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 has agreed to provide Lotus and 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 January 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 January 31, 2026.
Lotus and Alvogen’s ability to market lenalidomide in the U.S. will be contingent on its obtaining approval of an Abbreviated New Drug Application.
Commenting on this event, Lotus and Alvogen Chairman Robert Wessman said,
Lotus and Alvogen are very pleased to reach settlement with Celgene, which provides a volume-limited, date certain launch and removes any legal uncertainty and risk for our generic version of REVLIMID® in the US. For Lotus, after obtaining approval of Lenalidomide in Europe as the first generic, this is another particularly important milestone on its path to become the global preferred partner in oral oncology. Lenalidomide is the first product fully developed and manufactured in our facilities in Taiwan and to be launched in certain countries in Europe, Asia, Middle East, Latin America, as well as the US. REVLIMID®, as disclosed by Celgene, was the biggest non-biologic product globally with a US$10 billion sales and 70% of the value lies in the US market. This means Lenalidomide, following the earlier launch of our generic version of Suboxone sublingual film, is poised to become our next significant launch in the US marketplace. I am confident that this is the first of many important global launches to come from our US FDA, EMA, Japan PMDA and Taiwan FDA approved facilities in Taiwan.