Dr Reddy's Labs unveils cancer drug Lenalidomide in US

Hyderabad: Pharma major, Dr. Reddy's Laboratories Ltd., has recently announced the launch, in the U.S. market, of Lenalidomide Capsules, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules approved by U. S. Food and Drug Administration (USFDA).

With this volume-limited launch, Dr. Reddy's is eligible for first-to market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.

"We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity," says Marc Kikuchi, CEO, North America Generics, Dr. Reddy's Laboratories.

"Bringing a more affordable generic version to market creates greater patient access for this important drug." 

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As previously announced, Celgene agreed to provide Dr. Reddy's with a license to sell volume-limited amounts of generic lenalidomide capsules in the U.S. in settlement of all outstanding claims of its litigation. 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. Dr. Reddy's Lenalidomide Capsules are available in strengths of 2.5 mg, 5 mg, and 10 mg, each in a bottle-count size of 28, as well as 15 mg, 20 mg, and 25 mg strengths, each in a bottle-count size of 21.

Medical Dialogues team had earlier reported that Cipla Limited had also received final approval for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsule 5 mg, 10 mg, 15 mg and 25 mg from the USFDA.

Read also: Cipla Cancer drug Lenalidomide bags USFDA okay

Revlimid is a trademark of Celgene, a wholly-owned subsidiary of Bristol Myers Squibb.

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