Natco Pharma Limited — Updates, 10-02-2025: Press Release

NATCO Pharma Limited has secured final approval for its ANDA for Bosentan tablets for oral suspension (32mg), a generic version of Tracleer® from Actelion Pharmaceuticals. The product will be marketed in the U.S. by NATCO's partner, Lupin Pharmaceuticals. NATCO anticipates having sole First-to-File status, positioning it for a 180-day exclusivity upon launch, although specific launch details remain confidential.

This medicine is indicated for treating pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older, aimed at improving pulmonary vascular resistance. The U.S. market for Bosentan TFOS was estimated at USD 11 million for the year ending September 2024. This development highlights NATCO's commitment to expanding its portfolio in specialty pharmaceuticals and may present significant growth opportunities for investors as product sales are expected to enhance financial performance.