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( As on 20/08/2025 11:44)

Lupin launches Bosentan Tablets for Oral Suspension in US with 180-day exclusivity

Global pharma company Lupin Limited announced the launch of Bosentan Tablets for Oral Suspension, 32 mg, in the United States. The launch follows USFDA approval granted to Lupin’s alliance partner, NATCO Pharma Limited, for its Abbreviated New Drug Application (ANDA).

NATCO, holding exclusive first-to-file status, will enjoy 180 days of generic marketing exclusivity. The product is the generic equivalent of Tracleer® (Actelion Pharmaceuticals US, Inc.) and is indicated for the treatment of pulmonary arterial hypertension (PAH) in pediatric patients aged three years and above with idiopathic or congenital PAH, to improve pulmonary vascular resistance (PVR) and exercise capacity.

According to IQVIA MAT (June 2025), Bosentan Tablets (RLD: Tracleer®) recorded estimated annual sales of USD 10 million in the US.