Lupin's partner Natco obtains FDA nod for generic Tracleer

Lupin and its alliance partner Natco received clearance from the FDA for bosentan tablets for oral suspension, 32 mg, which is a generic equivalent of Actelion’s Tracleer. 

Natco is the exclusive first-to-file for this product and is eligible for 180 days exclusivity.

Bosentan tablets for oral suspension are indicated for the treatment of pulmonary arterial hypertension in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance, which is expected to result in an improvement in exercise ability.

[Read more: Lupin receives FDA OK for generic Banzel]

Bosentan tablets for oral suspension had a market value of roughly $11 million, per IQVIA December 2024 data.

[Read more: FDA gives Lupin OK for new generic, tentative nod for generic Triumeq]