Natco Pharma Launches Generic Pomalidomide in U.S. Market

Filed: March 3, 2026

Filing Summary

Natco Pharma Limited, in collaboration with Breckenridge Pharmaceutical, Inc., has launched Pomalidomide Capsules, a generic version of Pomalyst® by Celgene, in the U.S. market. The product is available in 1mg, 2mg, 3mg, and 4mg strengths. Pomalidomide is indicated for multiple myeloma and AIDS-related Kaposi sarcoma. The capsules had estimated U.S. sales of USD 3.2 billion for the 12 months ending September 2025. Natco has 180 days of shared exclusivity for this product, as per the U.S. FDA.

Natco Pharma Limited, in partnership with Breckenridge Pharmaceutical, Inc., has announced the launch of Pomalidomide Capsules, a generic version of Pomalyst® by Celgene, in the U.S. market. The launch date was March 3, 2026. The product is available in 1mg, 2mg, 3mg, and 4mg strengths and is distributed primarily through specialty pharmacies and clinics.

Pomalidomide is a thalidomide analogue 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. It 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.

The estimated sales for Pomalidomide Capsules in the U.S. were USD 3.2 billion for the 12 months ending September 2025, according to industry sales data. Natco Pharma has 180 days of shared exclusivity for this product, based on information from the U.S. Food and Drug Administration (FDA).

Breckenridge Pharmaceutical, Inc. focuses on delivering high-quality, affordable generic solutions. The launch of Pomalidomide Capsules is part of their ongoing commitment to expanding their specialty generics portfolio and improving access to affordable therapies for patients with complex conditions.

Natco Pharma Limited develops, manufactures, and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products. The company is a research and development-oriented, science-driven leader in oncology and focuses on limited competition molecules in the U.S. market. Natco operates nine manufacturing sites and two R&D facilities in India, with approvals from several leading regulatory authorities, catering to over 50 global markets.

Recent Filings from Natco Pharma

Date of Filing
Postings
Filing Type

Related Filings from Pharmaceuticals & Biotechnology

Date of Filing
Postings
Sub-Industry
Filing Type
Mar 6, 2026
Pharmaceuticals
New Product
Feb 25, 2026
Pharmaceuticals
New Product
Feb 4, 2026
Pharmaceuticals
New Product
Feb 2, 2026
Pharmaceuticals
New Product
Jan 22, 2026
Pharmaceuticals
New Product
Dec 23, 2025
Pharmaceuticals
New Product