Shares of Lupin Ltd. will be in focus on Wednesday, August 20, after the company announced the launch of Bosentan Tablets for Oral Suspension, 32 mg, in the United States. The launch, made in partnership with NATCO Pharma, comes with the advantage of 180-day first-to-file generic exclusivity, a significant opportunity in the niche space of pulmonary arterial hypertension (PAH) treatment.
The government filing confirmed that Lupin’s alliance partner NATCO Pharma received U.S. FDA approval for its Abbreviated New Drug Application (ANDA). Bosentan is indicated for the treatment of PAH in pediatric patients aged three years and above with idiopathic or congenital PAH, aiming to improve pulmonary vascular resistance and exercise ability. The drug is bioequivalent to Actelion Pharmaceuticals’ Tracleer® Tablets for Oral Suspension, which had estimated annual U.S. sales of around USD 10 million as of June 2025.
Lupin, a major player in generics and specialty formulations, continues to strengthen its U.S. portfolio with this launch. The company has a strong footprint across therapy areas, including respiratory, cardiovascular, anti-diabetic, and women’s health, and operates 15 manufacturing sites and seven research centers globally. With the exclusivity window, Lupin and NATCO are positioned to capture market share in the PAH treatment segment before competition intensifies.
Disclaimer: This article is for informational purposes only and should not be considered investment advice. Please consult a financial advisor before making any investment decisions.
