Lupin today announced the launch of Bosentan Tablets for Oral Suspension, 32 mg in the United States. This follows the approval received by Lupin's alliance partner, NATCO Pharma Limited (NATCO) for its Abbreviated New Drug Application from the United States Food and Drug Administration (U.S. FDA). NATCO holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity.
Bosentan Tablets for Oral Suspension, 32 mg, are bioequivalent to Tracleer® Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc. They are 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 (RLD Tracleer®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2025).