Mumbai, Feb. 10 -- The company's marketing partner for the ANDA, Lupin Pharmaceuticals Inc. (Lupin), will market the product in the U.S.

NATCO believes it has sole first-to-file status for the product and is eligible for a 180-day exclusivity at the time of launch.

Bosentan TFOS is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric 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) had estimated sales of $11 million in the U.S. for 12 months ending September 2024, as per industry sales data.

Natco Pharma is engaged in t...