Global pharma major Lupin has received approval from the United States Food and Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, 2.5 mg, 5 mg, 10 mg, 15 mg, 20 mg and 25 mg.

The approved product is bioequivalent to Revlimid Capsules in the same strengths from Bristol-Myers Squibb and will be manufactured at Lupin’s state-of-the-art facility in Pithampur, India.

Lenalidomide Capsules are indicated for the treatment of adult patients with multiple myeloma (MM) in combination with dexamethasone, and as maintenance therapy following autologous hematopoietic stem cell transplantation (auto-HSCT).

It is also used for the treatment of adult patients with transfusion-dependent anemia 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, Lenalidomide Capsules (RLD Revlimid) in the approved strengths had estimated annual sales of USD 7.51 billion in the US.

Headquartered in Mumbai, Lupin is a leading global pharmaceutical company with a presence in over 100 markets. The company’s portfolio spans branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients (APIs). With 15 world-class manufacturing facilities and seven research centres worldwide, Lupin maintains a strong presence in key therapeutic areas such as respiratory, cardiovascular, diabetes, anti-infectives, gastrointestinal, central nervous system, and women’s health.