Dr. Reddy’s Launches, Cipla Receives Approval for Generic Revlimid

Dr. Reddy’s received a first-to-market 180 days of exclusivity for the 2.5 mg and 20 mg strengths of its generic lenalidomide capsules.

Dr. Reddy’s Laboratories has launched lenalidomide capsules, a generic equivalent of Bristol Myers Squibb’s Revlimid (lenalidomide) capsules, which is used to treat patients with multiple myeloma, mantle cell lymphoma, and myelodysplastic syndromes, as a maintenance therapy following stem cell transplant.

Dr. Reddy’s received a first-to-market 180 days of exclusivity for the 2.5 mg and 20 mg strengths. Dr. Reddy’s lenalidomide is available in strengths of 2.5 mg, 5 mg, and 10 mg 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.

As previously announced, Celgene — now part of Bristol Myers Squibb — agreed to provide Dr. Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the United States in a settlement. As part of the settlement, Dr. Reddy’s is also licensed to sell generic lenalidomide capsules without volume limitation beginning Jan. 31, 2026.

Additionally, the FDA approved Cipla’s generic version of Revlimid capsules in 5 mg, 10 mg, 15 mg and 25 mg strengths. The company said the product will be shipping soon.

Teva Pharmaceuticals became the first to launch a generic of Revlimid in March 2022 in 5 mg, 10 mg, 15 mg, and 25 mg strengths.

Revlimid had annual sales of $2.58 billion for the 12-month period ending June 2022, according to IQVIA data.