Natco Pharma Launches Pomalidomide Capsules Generic in US Market
Natco Pharma and Breckenridge Pharmaceutical have launched Pomalidomide Capsules, a generic version of Pomalyst®, in the U.S. market. The drug, used for multiple myeloma and Kaposi sarcoma, had estimated U.S. sales of USD 3.2 billion for the 12 months ending Sep'25. Natco believes it has 180 days of shared exclusivity.
The launch of a generic drug in a major market like the U.S., particularly for a product with substantial sales and potential exclusivity, is expected to have a significant impact on Natco Pharma's revenue and market position in the oncology and specialty segments.
The launch of a generic drug, especially one with significant market sales and a period of exclusivity, is a positive development for the company, indicating revenue growth potential and increased market access.
Natco Pharma Limited, in collaboration with its partner Breckenridge Pharmaceutical, Inc., has announced the launch of Pomalidomide Capsules in the U.S. market. This is a generic version of Pomalyst® by Celgene.
Pomalidomide Capsules are indicated for adult patients with multiple myeloma who have undergone prior therapies including lenalidomide and a proteasome inhibitor, and have shown disease progression. It is also approved for AIDS-related Kaposi sarcoma and for HIV-negative adult patients with Kaposi sarcoma. The product is available in 1mg, 2mg, 3mg, and 4mg strengths and will be distributed through specialty pharmacies and clinics.
The estimated U.S. sales for Pomalidomide Capsules, 1mg, 2mg, 3mg and 4mg, were USD 3.2 billion for the 12 months ending September 2025, according to industry sales data. Natco Pharma believes it holds 180 days of shared exclusivity, based on information from the U.S. Food and Drug Administration (FDA).
Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer of Natco Pharma Limited, stated, "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."
Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, Inc., added, "Access and affordability continue to be major challenges for patients who depend on specialty therapies. Breckenridge’s launch of 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."
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