"Celgene has agreed to provide Natco with a license to Celgene's patents required to manufacture and sell an unlimited quantity of generic Lenalidomide in the United States beginning on January 31, 2026. In addition, Natco will receive a volume-limited license to sell generic Lenalidomide in the United states commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total Lenalidomide capsules dispensed in the US during the first full year of entry," Natco said in a statement.
Celgene's last patent on Revlimid (Lenalidomide) expires in April 2027.
The volume limitation is expected to increase gradually every year until March 2025, and is not expected to exceed one-third of the total Lenalidomide capsules dispensed in the US in the final year of the volume-limited license under this agreement, the company said.
The Revlimid of Celgene recorded sales of nearly $ 3.4 billion in the US market for the year ending September, 2015, according to Natco press release.