News Briefs: Dr. Reddy’s Launched Six Strengths of Lenalidomide

Oct 13
Oct 13, 2022

Dr. Reddy’s Laboratories Ltd. launched six strengths of lenalidomide, and two of them — 2.5 mg and 20 mg — are eligible for first-to-market 180-day exclusivity, the company said Sept. 7. The FDA approved those two strengths and gave tentative approval to the others on Oct. 14, 2021. Teva Pharmaceuticals Ltd. launched the first generics of the other four strengths of the generic of Bristol Myers Squibb’s Revlimid — 5 mg, 10 mg, 15 mg and 25 mg — on March 7. Lenalidomide is approved for six indications for the treatment of adults with (1) multiple myeloma in combination with dexamethasone; (2) MM as maintenance treatment following autologous hematopoietic stem cell transplantation; (3) transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality with or without additional cytogenic abnormalities; (4) mantle cell lymphoma that has relapsed or progressed after at least two treatments, including bortezomib; (5) previously treated follicular lymphoma in combination with a rituximab product; and (6) previously treated marginal zone lymphoma in combination with a rituximab product. Dosing is based on the indication. On Sept. 17, 2020, Dr. Reddy’s said that it had settled patent litigation with Bristol Myers subsidiary Celgene Corp. that would allow it to sell volume-limited amounts of the generic as of a confidential date after March 2022. As of Jan. 31, 2026, Dr. Reddy’s can sell lenalidomide without limitation. Read more
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.