Dr Reddy’s receives USFDA nod for Lenalidomide capsules

Hyderabad: Dr Reddy’s Laboratories received final approval of its Abbreviated New Drug Application (ANDA) from 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 (lenalidomide). With this […]

Hyderabad: Dr Reddy’s Laboratories received final approval of its Abbreviated New Drug Application (ANDA) from 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 (lenalidomide).

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

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In September 2020, Dr Reddy’s 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 patents for the branded drug.

In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr Reddy’s with a licence to sell volume-limited amounts of generic lenalidomide capsules in the US 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 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.”

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