Natco Pharma has announced the launch of Bosentan tablets for oral suspension in the United States market, marking a significant milestone for the company's expansion in the U.S. pharmaceutical sector.

Key Highlights

• Natco Pharma has introduced Bosentan tablets for oral suspension, 32mg, a generic version of Tracleer® by Actelion Pharmaceuticals US Inc.
• The company has secured 180-day exclusive marketing rights for this pharmaceutical product launch.
• Natco's marketing partner for the product in the U.S. is Lupin Limited.
• The drug is indicated for the treatment of pulmonary arterial hypertension (PAH) in pediatric patients aged 3 years and older with idiopathic or congenital PAH.

Market Potential

According to industry sales data, Bosentan tablets for oral suspension (32mg) had estimated sales of $10.00 million in the U.S. for the 12 months ending June 2025. This represents a significant market opportunity for Natco Pharma.

Strategic Importance

The launch of Bosentan tablets with 180-day exclusivity underscores Natco Pharma's growing presence in the U.S. generic drug market. This first-to-file status not only provides a competitive edge but also potentially contributes to the company's revenue growth in the coming quarters.

About the Product

Bosentan tablets are designed to improve pulmonary vascular resistance (PVR) in pediatric patients with pulmonary arterial hypertension, which is expected to result in an improvement in exercise ability.

Company Statement

While specific comments from company executives were not provided, the launch aligns with Natco Pharma's strategy of focusing on limited competition molecules in the U.S. market.

The successful launch of Bosentan tablets in the U.S. market with exclusivity rights demonstrates Natco Pharma's capabilities in developing and commercializing complex generic formulations. As the company continues to expand its presence in the U.S. pharmaceutical market, investors and industry observers will be watching closely to see how this launch contributes to Natco's financial performance in the coming quarters.

Natco Pharma , a leading Indian pharmaceutical company, reported a marginal decline in its consolidated revenue for the first quarter (Q1). The company's financial results and future outlook reflect both challenges and strategic initiatives in a dynamic pharmaceutical landscape.

Q1 Financial Highlights

Natco Pharma's consolidated revenue for Q1 stood at INR 1,390.60 crores, slightly down from INR 1,410.70 crores in the same period last year. Despite the revenue dip, the company maintained strong profitability:

• EBITDA: INR 632.70 crores with a 45.5% margin
• Net Profit: INR 480.30 crores

The company's Board of Directors declared an interim dividend of INR 2.00 per equity share.

Segment-wise Performance

Challenges and Future Outlook

Natco Pharma faced pricing pressure in its U.S. product portfolio, particularly for Revlimid, which is expected to decline further after Q2. The company's management anticipates a 20% drop in revenue and a 30% drop in profits.

Strategic Initiatives

To mitigate risks and diversify its portfolio, Natco Pharma has undertaken several strategic initiatives:

1. Acquisition in South Africa: The company acquired a 35.75% stake in South Africa's Adcock Ingram for INR 2,000.00 crores, aiming to reduce dependence on the U.S. market.

2. U.S. Market Focus: Natco plans to file 7-8 new products in the U.S. this year and is investing in high-value R&D projects.

3. Crop Health Sciences: This segment showed good demand pickup and is nearing breakeven, with a revenue of INR 34.70 crores in Q1.

4. R&D Investments: The company is focusing on cancer products, peptides, and oligopeptide-type products, with significant R&D expenses expected in Q1 and Q2.

Regulatory and Manufacturing Updates

The Kothur manufacturing facility inspection had multiple observations, and the company is awaiting resolution. Natco has addressed all queries and is cautiously optimistic about a positive outcome.

Future Products and Opportunities

1. Semaglutide: Natco is on track for the market formation expected next year, subject to regulatory clarity.

2. Risdiplam: The company is ready to launch, pending a verdict from the Delhi High Court in its case against Roche.

3. Pomalidomide: Natco has full approval and a settlement agreement, with the launch date currently confidential.

Natco Pharma's Vice Chairman and CEO, Rajeev Nannapaneni, expressed cautious optimism about the company's future, emphasizing the need for more clarity on various ongoing initiatives before providing detailed guidance for future years.

As Natco Pharma navigates through challenges in its core U.S. business, its strategic diversification and focus on high-value R&D projects may help offset potential revenue declines in the coming years.