Dr. Reddy’s Laboratories Ltd. on Wednesday announced the launch of Lenalidomide Capsules in the United States market. According to the company, this is the therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules approved by the U. S. Food and Drug Administration (USFDA).
The company claims that 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. 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 said in a statement.
In September 2020, 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.
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.
Lenalidomide is used to treat various types of cancers. According to doctors and experts, it slows or stops the growth of cancer cells. Moreover, it is also used to treat anemia in patients with certain blood or bone marrow disorders (myelodysplastic syndromes-MDS).