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That’s an exciting development! The approval for generic Bosentan Tablets for Oral Suspension by NATCO Pharma and Lupin is indeed a significant achievement. It not only helps address the critical need for accessible treatments for PAH in children but also demonstrates the companies’ capabilities in the competitive pharmaceutical landscape.
Global pharma major Lupin Limited (Lupin) and its alliance partner Natco Pharma Limited (Natco), today announced that they have received an approval from the United States Food and Drug Administration (U.S. 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 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 USD 11 million in the U.S. (IQVIA MAT December 2024).
The 180-day market exclusivity is a valuable strategic advantage, allowing them to capture a good portion of the market early on. PAH treatments are essential since the condition can severely impact patients’ quality of life. Making such therapies more affordable and widely available is crucial.
