NATCO Pharma on Tuesday announced the launch of generic Pomalidomide capsules indicated for the treatment of adult patients with blood and bone marrow cancer in the US market in partnership with Breckenridge Pharmaceutical, Inc.
Pomalidomide capsule is a generic version of Pomalyst by Celgene.
The product is available in 1mg, 2mg, 3mg, and 4mg strengths and is distributed primarily through speciality pharmacies and clinics, NATCO Pharma said in a regulatory filing.
Commenting on the launch, Vice Chairman and CEO Rajeev Nannapaneni said,"...this further strengthens our oncology and speciality portfolio in the US. The launch highlights our commitment to our mission of making speciality medicines accessible to all patients worldwide."
He further said, "We look forward to bringing more such complex and speciality products to the market in the coming years."
Breckenridge Pharmaceutical, Inc., President and Chief Commercial Officer, Brian Guy, said, "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."
Access and affordability continue to be major challenges for patients who depend on speciality therapies, Guy noted.
NATCO Pharma said Pomalidomide capsules 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.
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 company added.
Pomalidomide Capsules, 1mg, 2mg, 3mg and 4mg, had estimated sales of USD 3.2 billion in the US for the 12 months ended September 2025, as per industry sales data, it said.
NATCO believes, based on information made available by the US Food and Drug Administration (FDA), that it has 180 days of shared exclusivity for marketing the drug.
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