Lupin Limited, one of India’s leading and globally recognised pharmaceutical companies, has made a significant announcement by launching Bosentan Tablets for Oral Suspension, 32 mg in the United States. The launch, which was formally disclosed under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015, marks another major milestone in the company’s robust strategy to expand its global footprint in the generic pharmaceutical market, especially in high-value therapies in the United States.

The product launch follows the Abbreviated New Drug Application (ANDA) approval granted to Lupin’s alliance partner NATCO Pharma Limited by the United States Food and Drug Administration (U.S. FDA). NATCO holds the exclusive first-to-file status for this particular generic version of Bosentan, which grants a 180-day exclusivity period in the U.S. market. This exclusivity provides Lupin Limited with a competitive advantage and a valuable opportunity to capture a substantial share of the market as the sole generic manufacturer initially available to patients and healthcare providers seeking cost-effective treatment options for pulmonary arterial hypertension (PAH).

Bosentan Tablets for Oral Suspension, 32 mg, are bioequivalent to Tracleer® Tablets for Oral Suspension, originally developed by Actelion Pharmaceuticals US, Inc. and widely used in the treatment of pulmonary arterial hypertension (WHO Group 1). The product is specifically indicated for pediatric patients aged 3 years and older who are diagnosed with either idiopathic or congenital PAH. Its therapeutic purpose is to improve pulmonary vascular resistance (PVR), which in turn is expected to enhance exercise ability and quality of life in affected patients.

Pulmonary arterial hypertension is a rare but serious condition characterised by elevated blood pressure in the arteries of the lungs, which places significant pressure on the right side of the heart. Over time, this leads to right heart failure and reduced life expectancy, especially when appropriate treatment is not available. The availability of a generic Bosentan therapy from an established pharmaceutical company like Lupin Limited offers patients and healthcare providers access to a high-quality and affordable treatment option, which is critical in managing chronic conditions in paediatric populations.

The product’s performance in the market is expected to be strong. According to IQVIA MAT data for June 2025, Bosentan Tablets (RLD Tracleer®) generated an estimated USD 10 million in annual sales in the United States. With 180-day exclusivity, Lupin Limited is strategically positioned to significantly enhance its generic drug revenue in the U.S. market, allowing it to further strengthen its relationship with payers, hospital networks, and paediatric specialists.

This launch is aligned with Lupin Limited’s broader strategy of developing and commercialising complex generic formulations, which require advanced development capabilities and strong regulatory expertise. Over the years, Lupin has established itself as a global pharmaceutical leader, with operations spanning more than 100 countries, and a proven portfolio of therapeutic solutions in respiratory, cardiovascular, anti-infective, gastrointestinal, central nervous system, anti-diabetic, and women’s health segments.

By collaborating with NATCO Pharma Limited, Lupin gains access to experienced R&D capabilities and a proven track record of successful ANDA filings. NATCO’s ability to secure first-to-file status demonstrates its ability to develop a high-quality generic product that meets the rigorous standards set by the U.S. FDA. This in turn reinforces Lupin’s strategy of working with select partners to maximise opportunities in the largest pharmaceutical market in the world.

The Chief Executive Officer of Lupin Limited highlighted that the launch of Bosentan Tablets for Oral Suspension underscores the company’s commitment to improving patient access to affordable generic treatments, especially for conditions that require chronic management and incur high treatment costs. The launch also highlights Lupin’s continued leadership in the cardiology and respiratory therapy categories, both of which remain priority areas in the company’s growth strategy.

Equally important is the regulatory aspect of the announcement. Under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015, Lupin is required to disclose any information that could materially impact its operations and financial performance. By promptly announcing the launch of Bosentan Tablets in the US, the company has demonstrated its commitment to transparency and regulatory compliance, which continues to build confidence among shareholders, institutional investors, and regulatory authorities.

Lupin Limited operates 15 state-of-the-art manufacturing sites and 7 research centres around the world. These facilities reflect the company’s investment in quality, compliance, innovation, and operational excellence. The launch of Bosentan from a regulatory and manufacturing standpoint required careful coordination between R&D, manufacturing, and regulatory Affairs teams, reflecting the strength of Lupin’s internal processes.

Bosentan belongs to a class of drugs known as endothelin receptor antagonists, which help to block the action of endothelin, a substance in the body that causes blood vessels to constrict. By blocking endothelin, Bosentan helps relax and widen the blood vessels, particularly in the lungs, reducing the workload on the heart. When used in paediatric patients, timely diagnosis and treatment with Bosentan has been shown to improve clinical outcomes and slow the progression of PAH.

The 180-day exclusivity ensures that Lupin Limited will initially face no generic competition in the market, potentially providing a first-mover advantage and creating a meaningful revenue opportunity during the exclusivity period. The company will subsequently continue to benefit from its well-established distribution channels and strong relationships with healthcare providers and pharmacies across the United States.

Beyond the commercialization of this product, Lupin has signalled that it remains committed to research and development initiatives aimed at addressing complex medical needs in various therapy areas. The launch of Bosentan Tablets for Oral Suspension is expected to open new avenues for the company to expand its paediatric portfolio in the U.S. market and further strengthen its reputation as a reliable partner in the global healthcare sector.

This development is particularly noteworthy in light of the progress being made in AI-driven healthcare, personalised medicine, and real-world evidence-based treatments, which have reshaped patient expectations and regulatory standards. Lupin’s ability to navigate these trends while delivering high-quality, affordable treatments ensures that the company remains well positioned to meet the evolving needs of patients in India, the U.S., and other global markets.

In conclusion, the launch of Bosentan Tablets for Oral Suspension, 32 mg in the United States with 180-day exclusivity is a remarkable achievement for Lupin Limited. It highlights the company’s ability to successfully commercialise complex generics, comply with strict regulatory requirements, and seize market opportunities through timely product launches. With this initiative, Lupin Limited continues to build on its legacy of delivering effective, affordable, and innovative medical solutions, further solidifying its position as a global leader in the pharmaceutical industry and reinforcing its commitment to improving patient health outcomes worldwide.

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