"Global pharma major Lupin Limited (Lupin) and its alliance partner Natco Pharma Limited (Natco), announced that they have received an approval from the United States Food and Drug Administration (FDA) 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 paediatric 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 (Tracleer) had estimated annual sales of USD 11 million in the US (IQVIA MAT December 2024).
Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients.