Mumbai, Naples, August 20, 2025: 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).

About Lupin
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. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women’s health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries – Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions.
To know more, visit www.lupin.com  or follow us on LinkedIn https://www.linkedin.com/company/lupin
For further information or queries please contact –

Rajalakshmi Azariah
Vice President & Global Head – Corporate Communications, Lupin
rajalakshmiazariah@lupin.com

*Safe Harbor Statement
Tracleer® is a registered trademark of Actelion Pharmaceuticals US, Inc.