NATCO Pharma Limited has received final approval from the U.S. FDA for its Abbreviated New Drug Application (ANDA) for Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer® by Actelion Pharmaceuticals. The product will be marketed in the U.S. by NATCO’s partner, Lupin Pharmaceuticals, Inc.
NATCO believes it holds sole First-to-File (FTF) status, making it eligible for 180-day marketing exclusivity upon launch. However, launch details remain confidential.
Bosentan TFOS is indicated for treating pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH. It helps improve pulmonary vascular resistance (PVR), which is expected to enhance exercise capacity.
According to industry sales data, Bosentan TFOS 32mg recorded estimated U.S. sales of $11 million for the 12 months ending September 2024.
