Natco Pharma Enters USD 3.2 Billion US Pomalidomide Market, Claims 180-Day Exclusivity

Pomalidomide, a thalidomide analogue, is 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 following 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 will be distributed primarily through specialty pharmacies and clinics across the US.

According to industry sales data, Pomalidomide Capsules in the 1 mg to 4 mg strengths recorded estimated sales of approximately USD 3.2 billion in the US for the 12-month period ending September 2025. NATCO stated that, based on information made available by the U.S. Food and Drug Administration (USFDA), it believes it is eligible for 180 days of shared exclusivity in the US market.

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Rajeev Nannapaneni, Vice Chairman and Chief Executive Office of NATCO Pharma Limited 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.”

“Access and affordability continue to be major challenges for patients who depend on specialty therapies,” said Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, Inc. “ Breckenridge’s l aunch o f Pomalidomide Capsules delivers a high-quality, affordable generic solution, supported by copay assistance for eligible patients to help reduce treatment delays and ensure continuity of care. This milestone underscores Breckenridge’s ongoing commitment to expanding our specialty generics portfolio and improving access to affordable therapies for patients with complex conditions.”

Headquartered in Hyderabad, NATCO Pharma develops, manufactures and markets generic and specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products. The company operates nine manufacturing facilities and two R&D centres in India, with approvals from regulatory authorities including the USFDA, ANVISA (Brazil), Health Canada, and the WHO, and caters to more than 50 global markets.