NATCO Pharma Limited, in partnership with Breckenridge Pharmaceutical, Inc., announced the launch of Pomalidomide Capsules, a generic version of Pomalyst®, in the U.S. market on March 3, 2026. The drug is indicated for treating multiple myeloma and Kaposi sarcoma. The capsules are available in 1mg, 2mg, 3mg, and 4mg strengths. NATCO anticipates 180 days of shared exclusivity based on FDA information, as the branded product had estimated U.S. sales of USD 3.2 billion for the 12 months ending September 2025.
Joint Launch of Pomalidomide Generic in the U.S.
NATCO Pharma Limited confirmed the launch of Pomalidomide Capsules in the United States through its collaboration with Breckenridge Pharmaceutical, Inc. This product is the generic equivalent of Pomalyst® by Celgene. The official announcement date for this event was March 3rd, 2026.
Pomalidomide Capsules are a thalidomide analogue used in the treatment of adult patients suffering from multiple myeloma who have progressed after failing at least two prior therapies. Additionally, it is approved for AIDS-related Kaposi sarcoma and HIV-negative Kaposi sarcoma.
Product Availability and Market Significance
The generic product is being offered in four strengths: 1mg, 2mg, 3mg, and 4mg, and will be distributed through specialty pharmacies and clinics. NATCO indicated that the branded equivalent recorded estimated U.S. sales totaling USD 3.2 billion for the 12 months concluding in September ’25.
Based on information from the U.S. Food and Drug Administration (FDA), NATCO believes it is entitled to 180 days of shared exclusivity for this launch.
Management Commentary on Specialty Portfolio
Rajeev Nannapaneni, Vice Chairman and CEO of NATCO Pharma Limited, stated that this launch further strengthens NATCO’s oncology and specialty portfolio in the U.S., aligning with the company’s mission to increase accessibility to specialty medicines globally.
Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, Inc., highlighted that the launch delivers a high-quality, affordable generic solution, supplemented by copay assistance to ensure continuity of care for patients managing complex conditions.
Corporate Filings Reference
This intimation was officially made to the stock exchanges, referencing the required filing under the relevant SEBI regulations, and was signed by Ch. Venkat Ramesh, Company Secretary & Compliance Officer on March 3, 2026.
Source: BSE
