Latest news with #BosentanTFOS
The Hindu
a day ago
- Health
- The Hindu
Natco Pharma launches generic drug for PAH in the U.S.
Natco Pharma has launched Bosentan tablets for oral suspension, 32mg, a generic version of Actelion Pharmaceuticals' Tracleer in the U.S. It holds the first-to-file status for this product and will have 180-day generic drug exclusivity, Natco said on Wednesday (August 20, 2025. Lupin is its marketing partner for the product. Bosentan TFOS, 32mg, had estimated sales of $10 million in the U.S. for 12 months ending June'25, the Hyderabad-based company said citing industry sales data. The drug is 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 improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.
Business Upturn
2 days ago
- Health
- Business Upturn
Natco Pharma launches generic Bosentan tablets for oral suspension in the US with 180-day exclusivity
NATCO Pharma Limited has announced the launch of Bosentan tablets for oral suspension (TFOS), 32mg in the United States, a generic version of Tracleer® developed by Actelion Pharmaceuticals US Inc. The product will be marketed in partnership with Lupin Limited. NATCO holds the first-to-file status, securing 180 days of generic drug exclusivity for this launch. Bosentan TFOS is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged three years and older suffering from idiopathic or congenital PAH. The drug helps reduce pulmonary vascular resistance (PVR), which is expected to enhance exercise capacity in affected patients. Advertisement According to industry sales data, Bosentan tablets for oral suspension (32mg) recorded an estimated USD 10 million in U.S. sales for the 12 months ending June 2025. The launch strengthens NATCO's presence in the U.S. generics market and reinforces its strategy of focusing on niche, high-value products.
