Lupin and Natco secure US FDA approval for generic Bosentan tablets for oral suspension
Natco receives first-to-file exclusivity for Bosentan Tablets for Oral Suspension, 32 mg, in the US market
Lupin and its alliance partner Natco Pharma (Natco) have received approval from the United States Food and Drug Administration (U.S. FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg. The approval allows the companies to market a generic equivalent of Tracleer Tablets for Oral Suspension, developed by Actelion Pharmaceuticals US, Inc.
Natco holds exclusive first-to-file status for this product, making it eligible for 180 days of marketing exclusivity in the United States.
Bosentan Tablets for Oral Suspension 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 aims to improve pulmonary vascular resistance (PVR), which is expected to enhance exercise ability in affected patients.
According to IQVIA MAT data from December 2024, the reference listed drug (RLD) Tracleer had estimated annual sales of USD 11 million in the United States.