Cipla and Dr Reddys Lab receives FDA nod for marketing of generic version of REVLIMID (lenalidomide) Capsules. Both companies have received final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules.
With this volume-limited launch, Dr. Reddy’s Lab is eligible for first-to- market, 180 days of generic drug exclusivity for Lenalidomide Capsules in 2.5 mg and 20 mg strengths.
Lenalidomide Capsules are AB-rated therapeutic equivalent generic version of Bristol Myers Squibb’s (Celgene) Revlimid (Lenalidomide) Capsules.
In October 2021, Celgene agreed to provide Dr. Reddy’s Lab 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. And Cipla Lenalidomide Capsules are available in strengths of 5 mg, 10 mg, 15 mg and 25 mg.
Lenalidomide is an immunomodulatory prescription drug which is indicated for several hematological malignancies in adults such as Multiple Myeloma, Myelodysplastic syndromes, Mantle cell lymphoma, Follicular lymphoma, and Marginal Zone lymphoma. Depending on the type of cancer, it can be used as monotherapy or combination as a part of first line regimen, maintenance regimen or relapsed settings.
Lenalidomide capsules are not to be used in pregnant women. It is not known if lenalidomide is safe and effective in children. Lenalidomide Capsules should not be used to treat people with chronic lymphocytic leukemia (CLL) outside of a controlled clinical trial.
According to IQVIA (IMS Health), Revlimid (Lenalidomide) Capsules had US sales of approximately 2.58 billion USD for the 12-month period ending June 2022.
