Natco Pharma launches generic drug with 180-day exclusivity in US

Natco Pharma on Wednesday said it has launched a generic medication to treat high blood pressure in the lungs in the US with 180-day exclusivity.

The company has launched Bosentan tablets for oral suspension (32 mg), a generic version of Tracleer tablets by Actelion Pharmaceuticals US Inc.

Natco's marketing partner for the product is Lupin Ltd, the Hyderabad-based drug maker said in a regulatory filing.


Natco holds the first-to-file status for this product and will have 180-day generic drug exclusivity, it added.

The drug is indicated for the treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 3 years and older.

Bosentan tablets for oral suspension (32 mg) had estimated sales of USD 10 million in the US for 12 months ended June this year, as per industry sales data, Natco Pharma stated.

Shares of the drug firm were trading 0.53 per cent down at Rs 888.55 apiece on the BSE.