NATCO Pharma launches generic Bosentan tablets for oral suspension in the United States
NATCO partners with Lupin for Bosentan tablets, gains 180-day exclusivity for pulmonary arterial hypertension treatment in paediatric patients
NATCO Pharma (“NATCO”) has announced the launch of Bosentan tablets for oral suspension (TFOS), 32 mg, in the United States. The product is a generic version of Tracleer by Actelion Pharmaceuticals US Inc., and NATCO’s marketing partner for this product is Lupin Limited.
According to NATCO, the company holds the first-to-file status for this product and will have 180-day generic drug exclusivity. Bosentan tablets for oral suspension (TFOS), 32 mg, are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in paediatric patients aged three years and older with idiopathic or congenital PAH. The treatment is expected to improve pulmonary vascular resistance (PVR), leading to an improvement in exercise ability.
As per industry sales data, Bosentan tablets for oral suspension (TFOS), 32 mg, recorded estimated sales of USD 10 million in the United States for the twelve months ending June 2025.