NATCO Pharma Limited has announced the launch of Bosentan tablets for oral suspension (TFOS), 32mg in the United States, a generic version of Tracleer® developed by Actelion Pharmaceuticals US Inc. The product will be marketed in partnership with Lupin Limited.
NATCO holds the first-to-file status, securing 180 days of generic drug exclusivity for this launch. Bosentan TFOS is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged three years and older suffering from idiopathic or congenital PAH. The drug helps reduce pulmonary vascular resistance (PVR), which is expected to enhance exercise capacity in affected patients.
According to industry sales data, Bosentan tablets for oral suspension (32mg) recorded an estimated USD 10 million in U.S. sales for the 12 months ending June 2025.
The launch strengthens NATCO’s presence in the U.S. generics market and reinforces its strategy of focusing on niche, high-value products.