
New Launch20 Aug 2025, 10:49 am
Natco Pharma Launches Bosentan Tablets for Oral Suspension in US with 180-Day Exclusivity
AI Summary
Natco Pharma Limited has announced the launch of Bosentan tablets for oral suspension, a generic version of Tracleer®, in the United States. The company holds the first-to-file status for this product and will have 180-day generic drug exclusivity. The product is indicated for the treatment of pulmonary arterial hypertension in paediatric patients aged 3 years and older. Bosentan tablets for oral suspension had estimated sales of USD 10 million in the U.S. for 12 months ending June’25. Natco Pharma Limited is a Hyderabad-based company that develops, manufactures, and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients, and crop protection products.
Key Highlights
- Natco Pharma launches Bosentan Tablets for Oral Suspension in the US
- Product is a generic version of Tracleer®
- Natco holds first-to-file status and 180-day generic drug exclusivity
- Indicated for treatment of pulmonary arterial hypertension in paediatric patients
- Estimated sales of USD 10 million in the U.S. for 12 months ending June’25