NATCO Pharma Receives Final Approval for Bosentan Tablets, Eyeing 180-day Exclusivity

NATCO Pharma Limited has announced the final approval of its Abbreviated New Drug Application (ANDA) for Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer® by Actelion Pharmaceuticals US Inc. NATCO’s marketing partner, Lupin Pharmaceuticals, Inc., 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. The product is indicated for the treatment of pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older. 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.