Launch in US Market Planned in Collaboration with Breckenridge Pharmaceutical
Hyderabad, India – January 30, 2025: Natco Pharma Limited announced the approval of its Abbreviated New Drug Application (ANDA) for Everolimus tablets for oral suspension (TFOS) in strengths of 2mg, 3mg, and 5mg. This product is a generic version of AFINITOR DISPERZ® by Novartis Pharmaceutical Corporation.Market Launch and Financial Impact
Natco’s marketing partner, Breckenridge Pharmaceutical, Inc., plans to launch the product immediately in the US market. Everolimus TFOS is indicated for adult and pediatric patients (aged one year and older) with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that cannot be curatively resected.According to industry sales data, Everolimus tablets for oral suspension had estimated U.S. sales of $112 million for the 12 months ending September 2024.
Corporate Overview and Growth Strategy
Natco Pharma, headquartered in Hyderabad, India, is a research-driven pharmaceutical company specializing in oncology treatments, specialty generics, active pharmaceutical ingredients (APIs), and crop protection products. The company has nine manufacturing sites and two R&D facilities across India.Natco focuses on limited-competition molecules in the US market and has secured approvals from major regulatory bodies, including the U.S. FDA, Brazil ANVISA, Health Canada, and WHO. The company exports to over 50 global markets.
This approval further strengthens Natco’s foothold in the U.S. generics market, reinforcing its strategy of targeting niche and high-value products.
