Lupin has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application for Lenalidomide Capsules, in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg. These capsules are bioequivalent to Revlimid® and will be manufactured at Lupin’s Pithampur facility in India. Lenalidomide Capsules are used in the treatment of adult patients with multiple myeloma and other conditions.
FDA Approval for Lenalidomide Capsules
Lupin announced on September 17, 2025, that it has secured approval from the U.S. FDA for its Lenalidomide Capsules. The approval covers multiple strengths: 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.
Bioequivalence and Manufacturing
The approved Lenalidomide Capsules are bioequivalent to Revlimid® Capsules of Bristol-Myers Squibb Company. Production of these capsules will take place at Lupin’s manufacturing facility located in Pithampur, India.
Therapeutic Indications
Lenalidomide Capsules are indicated for use in adult patients for the treatment of:
- Multiple myeloma (MM) in combination with dexamethasone.
- MM as maintenance following autologous hematopoietic stem cell transplantation.
- Transfusion-dependent anemia due to certain myelodysplastic syndromes (MDS).
Market Potential
The annual sales for Lenalidomide Capsules (RLD Revlimid®) reached USD 7,511 million in the U.S. as of July 2025 (IQVIA MAT data), indicating a substantial market opportunity for Lupin following this approval.
Source: BSE