Dr Reddy’s Lab receives US FDA approval to market Lenalidomide capsule

Dr Reddy’s Laboratories today said it has received approval from the US health regulator to market Lenalidomide capsules, used to treat multiple myeloma and myelodysplastic syndromes.

The company has received final approval of its abbreviated new drug application (ANDA) 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 from the US Food and Drug Administration (FDA), the Hyderabad-based drug major said in a regulatory filing.

The company’s product is the generic version of Revlimid (lenalidomide) capsules.

With the approval, Dr Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg, the drugmaker said.

In September 2020, the company had announced a settlement agreement of their litigation with Celgene, the maker of Revlimid capsules and a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for the branded drug.

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 beginning on 31st January, 2026.

We are pleased with the Agency’s approval of Lenalidomide capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity. We look forward to bringing a more affordable generic version of this drug to market for the benefit of patients, Marc Kikuchi, CEO (North America Generics), Dr Reddy’s Laboratories, said.