Mon Feb 10 09:00:52 UTC 2025: **Natco Pharma’s Generic PAH Drug Approved by US FDA**
HYDERABAD, February 10, 2025 – Natco Pharma, a Hyderabad-based generic drug manufacturer, announced today that it has received final approval from the U.S. Food and Drug Administration (FDA) for its generic version of Tracleer, a pulmonary arterial hypertension (PAH) drug. The approved product, Bosentan tablets for oral suspension, 32mg, is expected to be marketed in the U.S. by Lupin Pharmaceuticals, Inc., Natco’s partner in the application process.
Natco believes it holds first-to-file status for this generic, granting it 180 days of market exclusivity upon launch. While specific launch details remain confidential, the company cites industry data estimating U.S. sales of the drug at $11 million in the 12 months ending September 2024. The drug is indicated for PAH treatment in patients aged 3 and older.
First Piper 