NATCO Pharma gets final approval for its ANDA for Bosentan tablets

Natco Pharma said that it has received final approval of its ANDA for Bosentan tablets for oral suspension (TFOS), which is a generic version of Tracleer by Actelion Pharmaceuticals US Inc.

The companys marketing partner for the ANDA, Lupin Pharmaceuticals Inc. (Lupin), 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.

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) had estimated sales of $11 million in the U.S. for 12 months ending September 2024, as per industry sales data.

Natco Pharma is engaged in the business of pharmaceuticals which comprises research and development, manufacturing and selling of bulk drugs and finished dosage formulations. The company has manufacturing facilities in India, which cater to both domestic and international markets, including regulated markets like the United States of America and Europe.

The companys consolidated net profit surged 83.55% to Rs 677.30 crore on a 32.93% increase in revenue from operations to Rs 1,371.1 crore in Q2 FY25 over Q2 FY24.

The scrip fell 1.24% to currently trade at Rs 1302.35 on the BSE.

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