Hyderabad-based NATCO Pharma has announced the approval of its s Abbreviated New Drug Application (ANDA) for Everolimus tablets for oral suspension (TFOS), 2mg, 3mg and 5mg, a generic version of AFINITOR DISPERZ by Novartis Pharmaceutical Corporation.

NATCO’s marketing partner for the ANDA, Breckenridge Pharmaceutical, Inc plans to launch the product immediately in the US market.

Everolimus TFOS is a kinase inhibitor indicated in adult and paediatric patients aged one year and older with tuberous sclerosis complex (TSC) for the treatment of subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected.

Everolimus tablets for oral suspension (TFOS), 2mg, 3mg and 5mg, had estimated sales of USD 112 million in the US for 12 months ending September 2024 as per industry sales data.

The company develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The company is an R&D-oriented, and science-driven, Oncology player in the targeted therapies of the domestic market and focuses on limited competition molecules in the US.

The company has 9 manufacturing sites and 2 R&D facilities in India. The company’s manufacturing facilities are approved by several leading regulatory authorities like the US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.