Natco Pharma has launched Bosentan tablets for oral suspension, 32mg, a generic version of Actelion Pharmaceuticals’ Tracleer in the U.S.

It holds the first-to-file status for this product and will have 180-day generic drug exclusivity, Natco said on Wednesday (August 20, 2025. Lupin is its marketing partner for the product.

Bosentan TFOS, 32mg, had estimated sales of $10 million in the U.S. for 12 months ending June’25, the Hyderabad-based company said citing industry sales data. The drug is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in paediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.