According to an exchange filing, NATCO holds exclusive first-to-file status for the product and will benefit from 180-day generic drug exclusivity. The product is the bioequivalent to Tracleer Tablets for Oral Suspension, marketed by Actelion Pharmaceuticals US, Inc.
Bosentan 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), which is expected to result in an improvement in exercise ability.
As per IQVIA MAT data for June 2025, Bosentan Tablets (RLD Tracleer) had estimated annual sales of approximately $10 million in the US market.
Lupin is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. It specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.
Lupin’s consolidated net profit jumped 52.13% to Rs 1,219.03 crore on 11.78% increase in income from operations to Rs 6,163.75 crore in Q1 FY26 over Q1 FY25.
Shares of Lupin declined 0.61% to Rs 1,956.50 on the BSE, while shares of Natco Pharma slipped 0.82% to Rs 885.95 on the BSE.