Lupin gains US FDA approval for generic Revlimid® capsules

Lupin Limited announced on September 17, 2025, that it has received approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules. These capsules, in strengths of 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg, are bioequivalent to Revlimid® Capsules from Bristol-Myers Squibb Company and will be manufactured at Lupin's Pithampur facility in India.

The approved capsules are indicated for treating adult patients with multiple myeloma (MM), both in combination with dexamethasone and as maintenance following autologous hematopoietic stem cell transplantation. They are also approved for transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with a deletion 5q abnormality.

According to IQVIA MAT July 2025 data, the estimated annual sales for Lenalidomide Capsules (RLD Revlimid®) in the U.S. were $7,511 million, highlighting the substantial market opportunity for Lupin's newly approved product.