Natco Pharma launches generic Zortress in US market

Natco Pharma Limited announced on October 31, 2025, the launch of Everolimus tablets 1mg, a generic version of Zortress® by Novartis. This immunosuppressant is indicated for the prophylaxis of organ rejection in adult patients undergoing kidney and liver transplantation.

Natco's marketing partner for the Abbreviated New Drug Application (ANDA), Breckenridge Pharmaceutical, Inc., a U.S. subsidiary of Towa International, is set to launch the product immediately in the U.S. market. Breckenridge had previously launched Everolimus tablets in 0.25mg, 0.5mg, and 0.75mg strengths, with blisters in July 2021 and bottles in June 2023.

Natco Pharma, headquartered in Hyderabad, India, develops, manufactures, and distributes generic and branded pharmaceuticals, including active pharmaceutical ingredients and crop protection products. The company operates 9 manufacturing sites and 2 R&D facilities in India, with facilities approved by various regulatory authorities such as the US FDA and Health Canada.