Natco Pharma Limited has announced that it has received USFDA approval for its Abbreviated New Drug Application (ANDA) for Everolimus tablets for oral suspension (TFOS) in 2mg, 3mg, and 5mg strengths. The drug is a generic version of AFINITOR DISPERZ® by Novartis Pharmaceutical Corporation.
Natco’s marketing partner, Breckenridge Pharmaceutical, Inc., is set to launch the product immediately in the US market, tapping into an estimated $112 million sales opportunity for the 12 months ending September 2024, based on industry data.
Everolimus TFOS is a kinase inhibitor used to treat subependymal giant cell astrocytoma (SEGA) in adult and pediatric patients (aged one year and older) with tuberous sclerosis complex (TSC) when the tumor cannot be surgically removed.
Natco Pharma, headquartered in Hyderabad, India, specializes in generic and specialty pharmaceuticals, oncology drugs, and active pharmaceutical ingredients (APIs). The company has nine manufacturing sites and two R&D facilities in India, with regulatory approvals from the USFDA, Brazil ANVISA, Health Canada, WHO, and others. It serves over 50 global markets.
This approval strengthens Natco’s portfolio in the US market and reinforces its position as a leader in developing limited-competition molecules. The launch of Everolimus TFOS is expected to enhance Natco’s presence in the high-value US generics segment, leveraging its expertise in complex drug formulations.
