NATCO launches Bosentan Tablets for Oral Suspension (generic of Tracleer®) in the United States with 180-day exclusivity

Hyderabad, India, August 20th, 2025: NATCO Pharma Limited (BSE: 524816 and NSE: NATCOPHARM) ("NATCO") today announced the launch of Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer® by Actelion Pharmaceuticals US Inc. NATCO’s marketing partner for the product is Lupin Limited. NATCO holds the first-to-file status for this product and will have 180-day generic drug exclusivity. They are 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 (PVR), which is expected to result in an improvement in exercise ability. Bosentan tablets for oral suspension (TFOS), 32mg had estimated sales of USD 10 million in the U.S. for 12 months ending June’25 as per industry sales data.

The release as fetched from its publisher. natcopharma.co.in ↗