Natco Pharma 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.
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.