Natco Pharma, in partnership with Breckenridge Pharmaceutical, Inc., has announced the launch of Pomalidomide capsules in the United States, marking a significant expansion of its oncology and specialty portfolio in the world’s largest pharmaceutical market.
The product is a generic version of Pomalyst, originally marketed by Celgene. Pomalidomide capsules are available in 1 mg, 2 mg, 3 mg and 4 mg strengths and will be distributed primarily through specialty pharmacies and clinics across the U.S.
Indications and Market Opportunity
Pomalidomide, 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.
The drug 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.
According to industry sales data, Pomalidomide capsules recorded estimated U.S. sales of approximately $3.2 billion for the 12 months ending September 2025, underscoring the sizeable commercial opportunity.
Natco said it believes it has secured 180 days of shared exclusivity, based on information available from the U.S. Food and Drug Administration (FDA).
Strengthening Oncology Portfolio
Natco Pharma vice-chairman & CEO Rajeev Nannapaneni said the launch reinforces the company’s focus on complex generics and specialty medicines in the US market.
“This further strengthens our oncology and specialty portfolio in the US. The launch highlights our commitment to making specialty medicines accessible to patients worldwide,” he said, adding that the company aims to introduce more complex and specialty products in the coming years.
The launch marks another milestone in Natco’s strategy to deepen its presence in high-value oncology segments in regulated markets while leveraging strategic partnerships to expand reach and patient access.
Breckenridge Pharmaceutical president & chief commercial officer Brian Guy said the launch addresses access and affordability challenges in 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,” he said.