Natco’s generic for PAH gets USFDA nod, marketing partner Lupin to launch product

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Natco Pharma has received U.S. Food and Drug Administration final approval for Bosentan tablets for oral suspension, 32mg, its generic version of Actelion Pharmaceuticals US Inc.’s pulmonary arterial hypertension drug Tracleer.

The Hyderabad-based generic drugmaker said it believes it has the sole first-to-file status for the product and consequently eligible for a 180-day exclusivity at the time of launch. Launch details are bound by confidentiality. Lupin Pharmaceuticals, Inc., which was its partner for the abbreviated new drug application approved by the U.S. FDA, will be marketing the product in the U.S., Natco said in a release on Monday (February 10, 2025).

Bosentan TFOS, 32mg, had estimated sales of $11 million in the U.S. for 12 months ended September 2024, the company said citing industry sales data. The product is indicated for the treatment of pulmonary arterial hypertension (PAH) in those aged 3 years and above with idiopathic or congenital PAH to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.