Lupin and Natco Secure FDA Approval for Bosentan Tablets

Lupin Limited, in alliance with Natco Pharma, has received approval from the U.S. Food and Drug Administration (FDA) for Bosentan Tablets, 32 mg, a generic version of Actelion Pharmaceuticals' Tracleer®. The tablets are indicated for treating pulmonary arterial hypertension in pediatric patients aged 3 years and older with idiopathic or congenital PAH.

Natco believes it has sole First-to-File status and is eligible for 180-day exclusivity at launch. The product had estimated sales of USD 11 million in the U.S. for the 12 months ending September 2024.

This approval strengthens Lupin's cardiovascular portfolio and Natco's position in the U.S. generics market. The companies expect this launch to contribute significantly to their revenues in the coming quarters.

Source: The Economic Times