Lupin Limited (Lupin) and its alliance partner Natco Pharma Limited (Natco) have received approval from the U.S. Food and Drug Administration (FDA) for Natco’s Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg. This approval allows the companies to market a generic equivalent of Tracleer® Tablets for Oral Suspension by Actelion Pharmaceuticals US, Inc.
As the exclusive first-to-file applicant, Natco holds a 180-day market exclusivity, providing a competitive edge in the U.S. pharmaceutical market.
Bosentan Tablets for Oral Suspension are used to treat pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH. The medication helps improve pulmonary vascular resistance (PVR), leading to enhanced exercise ability in affected children.
According to IQVIA MAT December 2024, the reference drug Tracleer® generated an estimated USD 11 million in annual U.S. sales. The introduction of this generic version is expected to offer affordable treatment options for pediatric PAH patients while strengthening Lupin and Natco’s presence in the U.S. market.
In the meantime, Lupin’s stock opened today at ₹2,201.90, reaching a high of ₹2,218.80 and a low of ₹2,151.50. The stock remains strong, trading near its 52-week high of ₹2,402.90, significantly above the 52-week low of ₹1,493.30. On the other hand, Natco Pharma’s stock opened at ₹1,314.05, reaching a high of ₹1,321.05 and a low of ₹1,287.05. The stock has seen a 52-week high of ₹1,639.00 and a low of ₹828.00.
