Dr Reddy's gets USFDA nod for lenalidomide capsules

Hyderabad: Dr Reddy's Laboratories Ltd received the final approval from the US Food and Drug Administration (USFDA) for lenalidomide capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of Revlimid capsules.

With this approval, Dr Reddy's is eligible for 180 days of generic drug exclusivity for lenalidomide capsules, 2.5 mg and 20 mg. In September 2020, the company announced a settlement agreement of their litigation with Celgene, the maker of Revlimid (lenalidomide) capsules and a wholly-owned subsidiary of Bristol Myers Squibb, relating to the patents.

In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the US beginning on a confidential date after March 2022 subject to regulatory approval. 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 from January 31, 2026. Marc Kikuchi, CEO, North America Generics, Dr Reddy's Laboratories, said: "We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients."