Natco Pharma receives approval for ANDA for Bosentan tablets

10 Feb 2025 Evaluate

Natco Pharma has received final approval for its Abbreviated New Drug Application (ANDA) for Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer by Actelion Pharmaceuticals US Inc.  The company's marketing partner for the ANDA, Lupin Pharmaceuticals, Inc. (Lupin) will market the product in the U.S. It has sole First-to-File status for the product and is eligible for a 180-day exclusivity at the time of launch.

Bosentan TFOS 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. 

Bosentan tablets for oral suspension (TFOS), 32mg had estimated sales of $11 million in the U.S. for 12 months ending Sep’24 as per industry sales data.

Natco Pharma was promoted as a private company to be in the business of research, developing, manufacturing and marketing of pharmaceutical substances and finished dosage forms for Indian and International markets.

Natco Pharma Share Price

806.35 1.55 (0.19%)
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