NATCO Pharma Receives Final Approval for Bosentan Tablets for Oral Suspension in U.S.

Hyderabad, India, February 10, 2025 – NATCO Pharma Limited (NSE: NATCOPHARM, BSE: 524816) has announced that it has received the final approval for its Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension (TFOS), 32 mg, a generic version of Tracleer® by Actelion Pharmaceuticals US Inc. The company’s marketing partner, Lupin Pharmaceuticals, Inc., will handle the product launch in the U.S.

Key Highlights of the Approval:​

• First-to-File Status: NATCO Pharma has sole First-to-File (FTF) status for this product, making it eligible for 180-day exclusivity upon launch.
• Indication: Bosentan TFOS is prescribed for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH. The drug helps improve pulmonary vascular resistance (PVR), which is expected to enhance exercise capacity.
• Market Size: Industry data estimates that Bosentan TFOS, 32 mg, recorded U.S. sales of approximately USD 11 million for the 12 months ending September 2024.

Strategic Impact for NATCO Pharma​

This approval reinforces NATCO’s strategy of focusing on limited competition molecules in the U.S. market. The company has a strong portfolio in oncology and specialty pharmaceuticals and continues to expand its pipeline with high-value generic and specialty drugs.

Company Overview​

NATCO Pharma is a Hyderabad-based pharmaceutical company engaged in the development, manufacturing, and distribution of generic and branded pharmaceuticals, specialty drugs, active pharmaceutical ingredients (APIs), and crop protection products. The company operates nine manufacturing facilities and two R&D centers in India, with approvals from global regulatory authorities such as the U.S. FDA, Brazil ANVISA, Health Canada, and WHO. NATCO’s global footprint extends to 50+ markets worldwide.

This milestone approval strengthens NATCO Pharma’s positioning in the U.S. market and enhances its commitment to bringing innovative and affordable treatment solutions to patients.