Lupin, Natco Launch Bosentan Tablets in US With 180-Day Exclusivity
Mumbai: Global pharma major Lupin Limited on Wednesday announced the launch of Bosentan Tablets for Oral Suspension, 32 mg in the United States, with 180-day generic drug exclusivity.
The launch follows approval received by Lupin’s alliance partner Natco Pharma Ltd, which holds the exclusive first-to-file status for the product’s Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (USFDA).
Bosentan Tablets for Oral Suspension, 32 mg, are the generic equivalent of Tracleer® Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc. The drug 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) and thereby enhance exercise ability.
According to IQVIA MAT June 2025 data, Bosentan Tablets (RLD Tracleer®) had estimated annual sales of USD 10 million in the U.S.
Lupin, headquartered in Mumbai, is among India’s leading pharmaceutical companies with a strong presence in the U.S. and over 100 markets globally. The company has 15 manufacturing sites, 7 research centers, and a workforce of over 24,000 professionals, with key strengths across therapies including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, CNS, and women’s health.
