Lupin launches Bosentan Tablets for Oral Suspension in the United States with 180-Day Exclusivity

Global pharma major Lupin Limited (Lupin) today announced the launch of Bosentan Tablets for Oral Suspension, 32 mg in the United States. This follows the approval received by Lupin's alliance partner, NATCO Pharma Limited (NATCO) for its Abbreviated New Drug Application from the United States Food and Drug Administration (U.S. FDA). NATCO holds the exclusive first-to-file status for this product and will have 180-day generic drug exclusivity.

Bosentan Tablets for Oral Suspension, 32 mg, are bioequivalent to Tracleer® Tablets for Oral Suspension of Actelion Pharmaceuticals US, Inc. They 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 (RLD Tracleer®) had estimated annual sales of USD 10 million in the U.S. (IQVIA MAT June 2025).

Shares of Lupin Limited was last trading in BSE at Rs. 1968.20 as compared to the previous close of Rs. 1969.45. The total number of shares traded during the day was 9175 in over 1293 trades.

The stock hit an intraday high of Rs. 1998.95 and intraday low of 1963.20. The net turnover during the day was Rs. 18094509.00.

Source : Equity Bulls

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Lupin INE326A01037 Pharmaceuticals USLaunch BosentanTablets OralSuspension 180DayExclusivity