Lupin and its alliance partner Natco Pharma have received an approval from the United States Food and Drug Administration (USFDA) for Natco’s Abbreviated New Drug Application (ANDA) for Bosentan Tablets for Oral Suspension, 32 mg, to market a generic equivalent of Tracleer Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc. 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 (PAH) (WHO Group 1) in pediatric patients aged 3 years and older with idiopathic or congenital PAH to improve pulmonary vascular resistance (PVR), which is expected to result in an improvement in exercise ability. Bosentan Tablets for Oral Suspension (RLD Tracleer) had estimated annual sales of $11 million in the U.S. (IQVIA MAT December 2024).
Lupin is an innovation led transnational pharmaceutical company producing, developing and marketing a wide range of branded and generic formulations, biotechnology products and active pharmaceutical ingredients (APIs) globally.
