Pomalidomide Capsules, a thalidomide analogue, are indicated for the treatment of adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression on or within 60 days of completion of the last therapy.
The drug is also approved for AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy (HAART), as well as for HIV-negative adult patients with Kaposi sarcoma. The product is available in 1 mg, 2 mg, 3 mg, and 4 mg strengths and is primarily distributed through specialty pharmacies and clinics.
NATCO said based on information made available by the U.S. Food and Drug Administration (FDA), it believes that it has 180 days of shared exclusivity. Pomalidomide Capsules 1 mg, 2 mg, 3 mg, and 4 mg had estimated sales of $3.2 billion in the U.S. for the 12 months ending September 2025, the company said, citing industry sales data.
Rajeev Nannapaneni, vice chairman and chief executive officer of NATCO Pharma, said, “We are pleased to launch Pomalidomide Capsules in the U.S.; this further strengthens our oncology and specialty portfolio in the U.S. The launch highlights our commitment to our mission of making specialty medicines accessible to all the patients worldwide. We look forward to bringing more such complex and specialty products to the market in the coming years.”
NATCO Pharma, headquartered in Hyderabad, India, develops, manufactures, and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products.
The company’s consolidated net profit jumped 13.9% to Rs 151.50 crore on a 36.3% increase in revenue from operations to Rs 647.30 crore in Q3 FY26 over Q3 FY25.