Natco Pharma gets final approval for Bosentan tablets for oral suspension
Hyderabad: NATCO Pharma Limited has announced final approval of its Abbreviated New Drug Application (ANDA) for Bosentan tablets for oral suspension (TFOS), 32mg, a generic version of Tracleer by Actelion Pharmaceuticals US Inc.
NATCO’s marketing partner for the ANDA, Lupin Pharmaceuticals, Inc. will market the product in the U.S.
"NATCO believes it has sole First-to-File status for the product and is eligible for a 180-day exclusivity at the time of launch. Launch details are bound by confidentiality," the Compay stated.
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 USD 11 million in the U.S. for 12 months ending Sep’24 as per industry sales data.
NATCO Pharma Limited, headquartered at Hyderabad, India, develops, manufactures and distributes generic and branded pharmaceuticals, specialty pharmaceuticals, active pharmaceutical ingredients and crop protection products. The Company is a R&D oriented, and a science driven, leading Oncology player in the targeted therapies of domestic market and focuses on limited competition molecule in the US. The Company has 9 manufacturing sites and 2 R&D facilities in India. The Company’s manufacturing facilities are approved by several leading regulatory authorities like US FDA, Brazil ANVISA, Health Canada, WHO and others catering to 50+ global markets.
