Dr. Reddy’s Labs Announces FDA Approval For Lenalidomide Capsules – Quick Facts

Dr. Reddy’s Laboratories Ltd. (RDY) announced Tuesday the final approval of its Abbreviated New Drug Application or ANDA for Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules, from the U.S. Food and Drug Administration or FDA.

The final approval for the drug is in 2.5 mg and 20 mg strengths, while the regulator also granted tentative approval in 5 mg, 10 mg, 15 mg, and 25 mg strengths.

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, Dr. Reddy’s announced a settlement agreement of its litigation with Celgene, the maker of REVLIMID (lenalidomide) Capsules and a subsidiary of Bristol Myers Squibb (BMY), 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 U.S. 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 U.S. without volume limitation beginning on January 31, 2026.

Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s, said, “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.”

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