NATCO Pharma Limited today announces final approval of its ANDA for Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer by Actelion Pharmaceuticals US Inc. NATCO’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.

Launch details are bound by confidentiality. 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), 32mg had estimated sales of USD 11 million in the U.S. for 12 months ending Sep’24 as per industry sales data.