Lupin and Natco Launch Generic Bosentan in US with 180-Day Exclusivity

Lupin said on Wednesday that it has launched the generic version of Bosentan tablets, 32 mg, in the US in partnership with Natco Pharma. The companies received approval for their Abbreviated New Drug Application with first-to-file status, giving them 180 days of marketing exclusivity.

Bosentan tablets for oral suspension are the generic equivalent of Tracleer, owned by Actelion Pharmaceuticals US, and are indicated for the treatment of pulmonary arterial hypertension in children aged three years and above.

The drug generated US sales of $10 million in the 12 months to June, according to Lupin, citing IQVIA data