Dr. Reddy’s Laboratories has received U.S. Food and Drug Administration (USFDA) approval for a generic version of anti-cancer drug Revlimid (lenalidomide) capsules.
The health regulator gave final approval for the company’s ANDA (abbreviated new drug application for Lenalidomide capsules), 2.5 mg and 20 mg strengths and tentative approval for 5 mg, 10 mg, 15 mg and 25 mg strengths. With the approval, the company will be eligible for 180 days of generic drug exclusivity for Lenalidomide capsules 2.5 mg and 20 mg, Dr. Reddy’s said in a release on Tuesday.
“We are pleased with the approval of Lenalidomide capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity... look forward to bringing a more affordable generic version of this drug to market,” said Marc Kikuchi, CEO-North America Generics.
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In September 2020, Dr. Reddy’s had announced a settlement agreement of litigation with Revlimid maker Celgene, relating to patents for the branded drug. In settlement of all outstanding claims in the litigation, Celgene, which is wholly-owned subsidiary of Bristol Myers Squibb, had 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 January 31, 2026, the release said.