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Natco Pharma Launches Generic Pomalidomide in US, Targets $3.2 Billion Oncology Market

Indian drugmaker enters high-value US blood cancer segment with generic version of Celgene’s Pomalyst

• By PharmaNews Live Desk
• New Delhi
• Mar 03, 2026

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Natco Pharma on Tuesday announced the launch of a generic version of pomalidomide capsules in the United States, expanding its oncology footprint in one of the world’s largest specialty drug markets.

The company said it has introduced the generic equivalent of Pomalyst (pomalidomide) in partnership with Breckenridge Pharmaceutical, Inc.. The product will be marketed in strengths of 1 mg, 2 mg, 3 mg and 4 mg.

Entry Into Key Blood Cancer Segment

Pomalidomide is prescribed for adult patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor, and have demonstrated disease progression. It is also indicated for certain patients with Kaposi sarcoma.

According to industry sales data cited by the company, the branded product recorded estimated annual sales of approximately $3.2 billion in the US for the 12 months ended September 2025, underscoring the commercial potential of the generic launch.

Natco stated that, based on information available from the US Food and Drug Administration (FDA), it expects to benefit from 180 days of shared generic exclusivity in the US market.

Company Statement

Rajeev Nannapaneni, Vice Chairman and Chief Executive Officer of Natco Pharma, said the launch strengthens the company’s specialty portfolio in the United States.

“This further strengthens our oncology and specialty portfolio in the US. The launch highlights our commitment to our mission of making specialty medicines accessible to all the patients worldwide,” he said.

He added, “We look forward to bringing more such complex and specialty products to the market in the coming years.”

Distribution and Patient Access

Breckenridge Pharmaceutical will handle commercialisation of the product in the US.

Brian Guy, President and Chief Commercial Officer of Breckenridge Pharmaceutical, said the launch aims to expand affordability and continuity of care.

“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.

The company noted that access and affordability continue to pose challenges for patients requiring specialised oncology therapies.

Strengthening US Oncology Presence

The launch marks another step in Natco Pharma’s strategy to focus on complex generics and specialty medicines in regulated markets, particularly in oncology. Indian pharmaceutical companies have increasingly targeted high-value segments in the US through patent challenges and first-to-file opportunities that offer limited-period exclusivity.

With this launch, Natco positions itself in a competitive but lucrative oncology segment, where pricing pressures and regulatory exclusivity windows significantly shape market dynamics.