NATCO Pharma Receives FDA Approval for Generic Everolimus Tablets

NATCO Pharma announced that it has obtained approval for its ANDA concerning Everolimus tablets for oral suspension (TFOS), a generic equivalent of AFINITOR DISPERZ from Novartis Pharmaceutical Corporation. Breckenridge Pharmaceutical, Inc, the company’s marketing partner for the ANDA, intends to introduce the product right away in the US market.

Everolimus TFOS is a kinase inhibitor approved for use in adults and pediatric patients aged one year and older diagnosed with tuberous sclerosis complex (TSC) for the management of subependymal giant cell astrocytoma (SEGA) needing treatment but not suitable for curative surgical resection.

Everolimus tablets for oral suspension (TFOS) were projected to have sales of $112 million in the U.S. for the year ending Sep24 according to industry sales data.

Natco Pharma operates in the pharmaceutical sector, involving research and development, production, and the sale of active ingredients and completed dosage forms. The company operates manufacturing plants in India, serving both local and global markets, encompassing regulated regions such as the United States and Europe.

The company's consolidated net profit jumped 83.55% to Rs 677.30 crore, driven by a 32.93% rise in operational revenue to Rs 1,371.1 crore in Q2 FY25 compared to Q2 FY24.