NATCO announces launch of Pomalidomide capsules in US

It is also approved for?AIDS-related Kaposi sarcoma?after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma

NATCO Pharma Limited long with its partner Breckenridge Pharmaceutical, announces launch of Pomalidomide Capsules, a generic version of Pomalyst by Celgene in the U.S. market.

Pomalidomide Capsules, 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.

It is also approved for AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma. The product is available in 1mg, 2mg, 3mg, and 4mg strengths and is distributed primarily through specialty pharmacies and clinics.

Pomalidomide Capsules, 1mg, 2mg, 3mg and 4mg, had estimated sales of USD 3.2 billion in the U.S. for 12 months ending Sep'25 as per industry sales data. NATCO believes based on information made available by the U.S. Food a nd Drug Administration (FDA) that it has 180 days of shared exclusivity.

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 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."