NATCO Pharma Limited, in partnership with Breckenridge Pharmaceutical, Inc., has announced the launch of Pomalidomide Capsules in the United States. The product is a generic version of Pomalyst®, originally developed by Celgene, and expands NATCO’s oncology and specialty pharmaceutical portfolio in the US market.
Pomalidomide Capsules are prescribed for adult patients with multiple myeloma who have previously received at least two treatments, including lenalidomide and a proteasome inhibitor, and whose disease progressed during or within 60 days after completing the last therapy. The medication is also approved for patients with AIDS-related Kaposi sarcoma who have not responded adequately to highly active antiretroviral therapy, as well as for HIV-negative adults diagnosed with Kaposi sarcoma. The newly introduced capsules are available in four dosage strengths—1 mg, 2 mg, 3 mg and 4 mg—and will primarily be distributed through specialty pharmacies and healthcare clinics across the United States.
According to industry sales data, the branded version of pomalidomide generated approximately USD 3.2 billion in sales in the United States during the twelve-month period ending September 2025. Based on publicly available information from the U.S. Food and Drug Administration (FDA), NATCO expects the product to benefit from a 180-day shared market exclusivity period.
Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer of NATCO Pharma Limited, said the launch represents another milestone in the company’s strategy to expand its presence in specialty medicines. He noted that the introduction of pomalidomide strengthens the company’s oncology portfolio in the US while reinforcing its commitment to improving patient access to advanced treatments.
Mr Nannapaneni also indicated that NATCO intends to continue bringing complex and specialty pharmaceutical products to market in the coming years. Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, Inc, highlighted the importance of affordability and accessibility for patients who rely on specialty medications. He stated that the launch of the generic pomalidomide capsules offers a cost-effective treatment option while maintaining high quality standards. Breckenridge will support the product launch with copay assistance programs for eligible patients, helping to reduce financial barriers and minimize treatment interruptions.
Headquartered in Hyderabad, NATCO Pharma Limited develops, manufactures and markets generic and branded pharmaceuticals, specialty medicines, active pharmaceutical ingredients and crop protection products. The company operates nine manufacturing facilities and two research and development centers in India.
NATCO’s manufacturing sites are approved by global regulatory authorities including the US FDA, Brazil’s ANVISA, Health Canada and the World Health Organization. Its products are distributed in more than 50 international markets, with a strong focus on oncology and targeted therapies.
