NATCO Pharma Limited has announced the launch of Pomalidomide Capsules, a generic version of Celgene's Pomalyst®, in the United States market. The launch is being executed in partnership with Breckenridge Pharmaceutical, Inc, marking a significant addition to the company's oncology portfolio.

Product Details and Market Opportunity

Pomalidomide Capsules is a thalidomide analogue with multiple therapeutic applications. The product is available in four different strengths and targets substantial market opportunities.

Therapeutic Applications

The medication serves critical treatment needs across multiple patient populations:

• Multiple Myeloma: Treatment for adult patients who have received at least two prior therapies including lenalidomide and a proteasome inhibitor, with demonstrated disease progression on or within 60 days of completion of the last therapy
• AIDS-related Kaposi Sarcoma: Approved for use after failure of highly active antiretroviral therapy
• HIV-negative Kaposi Sarcoma: Treatment option for adult patients with this condition

Leadership Commentary

Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer of NATCO Pharma Limited, emphasized the strategic importance of this launch: "We are pleased to launch Pomalidomide Capsules in the U.S., this further strengthens our oncology and specialty portfolio in the U.S. The launch highlights our commitment to our mission of making specialty medicines accessible to all the patients worldwide."

Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, Inc, highlighted the patient access benefits: "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."

Strategic Significance

The launch represents a major milestone for NATCO Pharma's US operations, particularly in the specialty oncology segment. Based on FDA information, the company believes it has secured 180 days of shared exclusivity for this product. This exclusivity period, combined with the substantial market size of USD 3.20 billion, positions the launch as a significant revenue opportunity.

The partnership with Breckenridge Pharmaceutical demonstrates NATCO's strategy of collaborating with established US partners to enhance market penetration and patient access. The focus on specialty pharmacies and clinics as primary distribution channels aligns with the complex nature of oncology treatments and the need for specialized patient support services.

Natco Pharma has received regulatory approval from the Central Drugs Standard Control Organisation (CDSCO) for semaglutide in India, marking a significant milestone in the company's pharmaceutical portfolio expansion. The company has now provided additional clarification regarding its partnership strategy following exchange queries.

Regulatory Approval and Product Details

The CDSCO approval, received on February 14, 2026, enables Natco Pharma to manufacture and distribute semaglutide in the Indian market. Semaglutide is a medication used for managing diabetes and weight management, representing an important addition to the company's therapeutic offerings.

Partnership Strategy and Launch Timeline

In a clarification to BSE Limited dated February 25, 2026, Natco Pharma confirmed its collaboration approach for the semaglutide launch. The company stated it is working with different marketing partners to launch the product in March 2026 in India.

Eris Lifesciences Partnership Details

The company specifically mentioned its partnership with Eris Lifesciences Ltd for the semaglutide product. According to the BSE clarification, this partnership is in the ordinary course of business and has no material impact on the company's operations.

Financial and Operational Impact

Natco Pharma has consistently stated that the semaglutide launch will not significantly affect its operations or financial performance. In the recent clarification, the company reiterated that there is no material financial impact from the partnership or product launch activities.

Regulatory Compliance

The company emphasized its commitment to regulatory compliance, stating it has been consistently making disclosures to stock exchanges as required under Regulation 30 of the SEBI (LODR) Regulations, 2015. The clarification was signed by Ch. Venkat Ramesh, Company Secretary & Compliance Officer, confirming the company's adherence to disclosure requirements.