India Pharma Outlook Team | Thursday, 21 August 2025
NATCO Pharma Limited has announced the launch of Bosentan tablets for oral suspension (TFOS), 32 mg, in the United States. The product is a generic equivalent to Tracleer, developed by Actelion Pharmaceuticals US, Inc. NATCO's launch partner is Lupin Limited.
NATCO has the distinguished first-to-file status for this product, along with the associated 180 days of marketing exclusivity in the U.S. generic drug industry, which means they can be the only generic supplier of Bosentan TFOS during the initial launch period. That provides a tremendous competitive advantage.
Bosentan TFOS is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in paediatric patients 3 years of age and older with idiopathic or congenital PAH. The therapy includes a reduction in pulmonary vascular resistance (PVR), which is expected to enhance the exercise capacity and quality of life in these patients. Bosentan TFOS will address an important unmet need in the care of paediatrics and provide identified treatment options for PAH in pediatrics.
Also Read: Natureoroma Launches Squacare Gel for Oral Submucous Fibrosis Patients
Bosentan tablets for oral suspension, 32 mg, are estimated to have generated approximately USD 10 million in annual sales in the U.S. during the 12 months ending June 2025, according to industry sales data. The launch is another step for NATCO to broaden its mark in niche generics generally, and in complex therapies specifically, which have barriers to entry.
By partnering with Lupin, NATCO is further enhancing its marketing reach in the U.S. and increasing access to the therapy for patients. Given the exclusivity window and targeted entry into a developed market, NATCO should benefit from clinical research and commercial investment associated with the launch in the months ahead.
