Natco Pharma Limited (BSE: 524816 | NSE: NATCOPHARM) has announced the launch of Pomalidomide Capsules in the United States in partnership with Breckenridge Pharmaceutical, Inc.. The product is a generic version of Pomalyst, originally marketed by Celgene.
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. The drug is also approved for the treatment of AIDS-related Kaposi sarcoma after failure of highly active antiretroviral therapy, as well as for HIV-negative adult patients with Kaposi sarcoma.
The capsules are available in 1mg, 2mg, 3mg, and 4mg strengths and will be distributed primarily through specialty pharmacies and clinics across the US. Pomalidomide is a thalidomide analogue widely used in advanced-stage multiple myeloma treatment.
According to industry sales data, Pomalidomide Capsules in the US recorded estimated sales of USD 3.2 billion for the 12-month period ending September 2025. The significant market size underscores the commercial opportunity for generic manufacturers entering this segment.
Natco Pharma stated that, based on information made available by the US Food and Drug Administration, it believes it has secured 180 days of shared exclusivity for the product in the US market. This exclusivity period could provide a competitive advantage during the initial phase of commercialization.