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The new generic formulation matches the composition of Celgene’s original Pomalyst medication and comes in four different strengths: 1mg, 2mg, 3mg, and 4mg.

USA—Indian multinational Natco Pharma has entered a strategic partnership with Breckenridge Pharmaceutical, Inc. to bring an affordable generic version of Pomalidomide capsules to American patients.
The launch represents a significant expansion of the company’s specialty pharmaceutical portfolio in the United States, addressing critical treatment gaps for patients with serious blood and bone marrow disorders.
The new generic formulation matches the composition of Celgene’s original Pomalyst medication and comes in four different strengths: 1 mg, 2 mg, 3 mg, and 4 mg.
Rather than rely solely on traditional retail channels, the manufacturers have chosen to distribute the product primarily through specialty pharmacies and clinical settings, ensuring that patients receive appropriate medical guidance alongside their treatment.
Expanding access to specialty medicines
According to industry data, Pomalidomide capsules generated approximately USD 3.2 billion in annual sales across the United States during the 12-month period ending September 2025.
This substantial market demand underscores the critical need for more affordable treatment alternatives.
Natco Pharma’s entry into this space through generic production creates meaningful opportunities for patients who struggle with the financial burden of specialty medications.
Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer of Natco Pharma, highlighted the company’s broader commitment to making complex therapies accessible worldwide.
He emphasized that this launch strengthens the organization’s presence in the oncology and specialty medicine sectors while reinforcing their dedication to developing innovative solutions for patients in need.
Broad clinical applications
Healthcare providers can prescribe the generic Pomalidomide capsules for multiple conditions affecting patients with compromised immune systems.
The medication addresses multiple myeloma in adult patients who have already received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and who continue to experience disease progression despite treatment.
Beyond multiple myeloma, the drug proves effective for managing AIDS-related Kaposi sarcoma in patients who have not responded adequately to highly active antiretroviral therapy, as well as for HIV-negative adult patients diagnosed with Kaposi sarcoma.
Affordability and patient support
Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, stressed the importance of affordability in specialty medicine.
He noted that the new generic option delivers a high-quality alternative at a more accessible price point, supported by copay assistance programs designed to help eligible patients reduce out-of-pocket costs.
These support mechanisms work to prevent treatment delays and maintain continuity of care for vulnerable patient populations.
Access and affordability remain persistent obstacles for individuals who depend on specialty therapies for survival.
This launch addresses those challenges directly by offering a more economical path to necessary treatment.
Based on information provided by the US Food and Drug Administration, Natco Pharma holds 180 days of shared exclusivity for marketing this drug, providing a defined window during which the company can establish its market presence.
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