Mumbai, Naples, February 10, 2025: 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).

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 22,000 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.