Dr Reddy's introduces generic Revlimid in US market

Dr. Reddy's Laboratories Ltd has announced the launch of Lenalidomide Capsules, a therapeutic equivalent generic version of Revlimid (lenalidomide) Capsules approved by the US Food and Drug Administration (USFDA) in the US market. A press release from the Hyderabad-based drug maker said with this volume-limited launch, 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. The drug is used to treat various types of cancers.

"We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity. Bringing a more affordable generic version to market creates greater patient access for this important drug," Marc Kikuchi, CEO, North America Generics, Dr. Reddy's said.

As previously announced, Celgene, the makers of Revlimid 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.

Dr. Reddy's Lenalidomide Capsules are available in strengths of 2.5 mg, 5 mg, and 10 mg, each in a bottle-count size of 28, as well as 15 mg, 20 mg, and 25 mg strengths, each in a bottle-count size of 21.