Lupin Limited — Updates, 10-02-2025: Press Release

Lupin Limited, in partnership with Natco Pharma Limited, has received U.S. FDA approval for Bosentan Tablets for Oral Suspension, 32 mg, marking a significant step in their product offerings. This approval allows them to market a generic version of Tracleer® Tablets, used for treating pulmonary arterial hypertension (PAH) in pediatric patients aged three years and older. Natco holds the exclusive first-to-file status, granting them 180 days of market exclusivity for this product. The estimated annual sales for Bosentan Tablets in the U.S. stand at approximately USD 11 million, highlighting the revenue potential. This development positions Lupin favorably in the U.S. market, presenting a positive outlook for revenue growth given the demand for effective treatment options in pediatric PAH.