Dr. Reddy’s Laboratories Announces the Launch of Lenalidomide Capsules in the U.S. With Two of Six Strengths Eligible for First-to-market, 180-day Exclusivity


Lenalidomide Capsules, a therapeutically similar and FDA-approved generic version of REVLIMID (lenalidomide) Capsules, were made available on the U.S. market today, according to Dr. Reddy’s Laboratories Ltd. (USFDA). Dr. Reddy’s is qualified for first-to-market, 180-day generic medication exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths with this volume-restricted launch.

“We are pleased with the first-to-market launch of two of our six strengths of Lenalidomide Capsules with 180-day market exclusivity”, “Bringing a more affordable generic version to market creates greater patient access for this important drug.”

Marc Kikuchi, CEO, North America Generics, Dr. Reddy’s Laboratories

As was previously stated, as part of the settlement of all outstanding claims in its litigation, Celgene consented to provide Dr. Reddy’s a licence to distribute volume-restricted quantities of generic lenalidomide capsules in the United States. The percentages that were agreed upon are kept private. In accordance with the settlement, Dr. Reddy’s has also been granted permission to start selling generic lenalidomide capsules in the United States on January 31, 2026, without any volume restrictions.

There are 28-count bottle sizes of the 2.5 mg, 5 mg, and 10 mg strengths of Dr. Reddy’s Lenalidomide Capsules as well as 21-count bottle sizes of the 15 mg, 20 mg, and 25 mg strengths.

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