Global pharma major Lupin Limited (Lupin) has announced that it has received approval from the United States Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide capsules in 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 25 mg strengths. These capsules are bioequivalent to Revlimid capsules of corresponding strengths from Bristol-Myers Squibb Company. The product will be manufactured at Lupin’s Pithampur facility in India.
Lenalidomide capsules are indicated for use in adult patients with:
Multiple Myeloma (MM), in combination with Dexamethasone
MM as maintenance therapy following autologous hematopoietic stem cell transplantation (auto-HSCT)
Transfusion-dependent anaemia due to low- or intermediate-1-risk Myelodysplastic Syndromes (MDS) associated with a deletion 5q abnormality, with or without additional cytogenetic abnormalities
According to IQVIA MAT July 2025 data, lenalidomide capsules (RLD Revlimid) in the mentioned strengths had estimated annual sales of USD 7,511 million in the US.