Lupin Limited has informed the Exchange regarding a press release dated August 20, 2025, titled "Lupin Launches Bosentan Tablets for Oral Suspension in the United Stateswith 180-Day Exclusivity".
LUPIN · price
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Lupin has launched Bosentan Tablets for Oral Suspension (32 mg) in the United States, following FDA approval of its alliance partner NATCO Pharma's Abbreviated New Drug Application. NATCO holds the first-to-file status, giving 180-day generic exclusivity for this product. The drug is a generic version of Tracleer® by Actelion Pharmaceuticals and is used to treat pulmonary arterial hypertension in pediatric patients aged 3 and older. The product had estimated annual U.S. sales of USD 10 million (IQVIA MAT June 2025).
The launch strengthens Lupin's U.S. generic portfolio and gives it a temporary monopoly-like advantage through 180-day exclusivity, though the USD 10 million addressable market is modest relative to Lupin's overall scale. It signals continued momentum in the company's U.S. complex generics strategy.