Dr. Reddy’s Laboratories has launched Lenalidomide Capsules, a therapeutic equivalent generic version of Revlimid (lenalidomide) capsules, in the US with approval from the US Food and Drug Administration (USFDA).
With this volume-limited launch, Hyderabad-based Dr. Reddy’s is eligible for first-to-market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.
“We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules, with 180-day market exclusivity,” Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories said in a release.
“Bringing a more affordable generic version to market creates greater patient access for this important drug,” he added.
As previously announced, Celgene agreed to provide Dr. Reddy’s with a licence to sell volume-limited amounts of generic lenalidomide capsules in the US in settlement of all outstanding claims of its litigation.
The agreed-upon percentages remain confidential. As part of the settlement, Dr. Reddy’s is also licensed to sell generic lenalidomide capsules in the US without volume limitation beginning on January 31, 2026.
Revlimid is a trademark of Celgene, a wholly-owned subsidiary of Bristol Myers Squibb. It is indicated to treat adults with multiple myeloma.