Lupin Limited has exciting news for patients and investors alike. The company announced that it has received approval from the U.S. Food and Drug Administration (FDA) for its Lenalidomide Capsules in multiple strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg.
These capsules are bioequivalent to Revlimid® Capsules of Bristol-Myers Squibb, meaning they work the same way in the body. Lupin will manufacture the product at its Pithampur facility in India.
Lenalidomide Capsules are used to treat adult patients with a variety of conditions, including:
-
Multiple myeloma (MM) in combination with dexamethasone
-
MM as maintenance therapy following stem cell transplantation
-
Transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) with certain genetic abnormalities
Revlimid®, the reference drug, had estimated annual sales of over USD 7.5 billion in the U.S. as of July 2025, highlighting the significant potential for Lupin’s launch.
With this approval, Lupin is set to expand its footprint in the U.S. oncology market, providing patients with an affordable alternative to a leading cancer therapy.
