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Business Upturn
a day ago
- Health
- Business Upturn
Natco Pharma launches generic Bosentan tablets for oral suspension in the US with 180-day exclusivity
NATCO Pharma Limited has announced the launch of Bosentan tablets for oral suspension (TFOS), 32mg in the United States, a generic version of Tracleer® developed by Actelion Pharmaceuticals US Inc. The product will be marketed in partnership with Lupin Limited. NATCO holds the first-to-file status, securing 180 days of generic drug exclusivity for this launch. Bosentan TFOS is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) in pediatric patients aged three years and older suffering from idiopathic or congenital PAH. The drug helps reduce pulmonary vascular resistance (PVR), which is expected to enhance exercise capacity in affected patients. Advertisement According to industry sales data, Bosentan tablets for oral suspension (32mg) recorded an estimated USD 10 million in U.S. sales for the 12 months ending June 2025. The launch strengthens NATCO's presence in the U.S. generics market and reinforces its strategy of focusing on niche, high-value products.
Business Upturn
a day ago
- Business
- Business Upturn
Lupin launches Bosentan Tablets for Oral Suspension in US with 180-day exclusivity
By Aditya Bhagchandani Published on August 20, 2025, 10:16 IST 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. Ahmedabad Plane Crash Aditya Bhagchandani serves as the Senior Editor and Writer at Business Upturn, where he leads coverage across the Business, Finance, Corporate, and Stock Market segments. With a keen eye for detail and a commitment to journalistic integrity, he not only contributes insightful articles but also oversees editorial direction for the reporting team.
