NATCO Pharma has announced the launch of Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer by Actelion Pharmaceuticals US Inc., in partnership with Lupin.

NATCO holds the first-to-file status for this product, securing 180-day generic drug exclusivity.

Bosentan tablets are indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in paediatric patients aged 3 years and older with idiopathic or congenital PAH to reduce pulmonary vascular resistance (PVR) and improve exercise ability.

According to industry sales data, Bosentan TFOS 32 mg recorded estimated sales of USD 10 million in the US for the 12 months ending June 2025.

Headquartered in Hyderabad, India, NATCO develops, manufactures, and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients (APIs), and crop protection products.  

A leading oncology-focused, research and development-driven company, NATCO specialises in limited-competition molecules in the U.S. market. It operates nine manufacturing sites and two R&D facilities in India, with approvals from major regulatory agencies including the U.S. FDA, Brazil’s ANVISA, Health Canada, WHO, among others, serving over 50 global markets.

A leading oncology player in the targeted therapies, NATCO specialises in limited competition molecules in the US. The company has nine manufacturing sites and two research and development facilities in India.