Lupin Limited , a global pharmaceutical leader, has made a significant stride in the U.S. market with the launch of Risperidone Long-Acting Injectable. This antipsychotic medication comes with a 180-day Competitive Generic Therapy (CGT) exclusivity, positioning Lupin at a competitive advantage in the market.

Key Highlights of the Launch

• Product: Risperidone for extended-release injectable suspension
• Dosages: 25 mg, 37.5 mg, and 50 mg per vial (Single-Dose Vials)
• Market: United States
• Exclusivity: 180-day CGT exclusivity
• Technology Platform: PrecisionSphere™ (Lupin's proprietary long-acting injectable platform)

Significance of the Launch

This launch marks a pivotal moment for Lupin, as it represents the first commercial product utilizing their PrecisionSphere™ technology. Developed by Lupin's subsidiary Nanomi B.V., this long-acting injectable (LAI) platform showcases the company's growing capabilities in specialized drug delivery systems.

Spiro Gavaris, President of U.S. Generics at Lupin, emphasized the importance of this launch, stating, "It highlights our commitment to expanding our portfolio of differentiated, complex products, marking a significant step forward in our pursuit of developing novel long-acting injectables across diverse therapeutic areas."

PrecisionSphere™ Technology

The PrecisionSphere™ platform offers several advantages:

• Creation of uniform microspheres
• Extended-release profiles ranging from weeks to months
• Superior injectability through smaller needles
• Consistent drug concentrations

These features potentially enhance patient compliance and treatment efficacy, particularly crucial for medications treating conditions like schizophrenia and bipolar disorder.

Market Potential

The launch taps into a substantial market opportunity. According to IQVIA data, the estimated sales for Risperidone for extended-release injectable suspension (referencing Risperdal Consta®) in the U.S. were approximately USD 187.00 million for the 25 mg, 37.5 mg, and 50 mg doses combined (MAT September 2025).

Strategic Implications

Dr. Fabrice Egros, President of Corporate Development at Lupin, highlighted the strategic importance of this launch, noting, "PrecisionSphere's proven capabilities, combined with our track record of successful partnerships, uniquely position us to expand global access to advanced long-acting injectable treatments."

Lupin is actively seeking to leverage this technology beyond its internal pipeline, exploring potential collaborations with other companies to extend product lifecycles and expand patient access to advanced LAI treatments.

Conclusion

The successful launch of Risperidone Long-Acting Injectable in the U.S. market represents a significant milestone for Lupin. It not only demonstrates the company's growing expertise in complex injectables but also validates the capabilities of its PrecisionSphere™ technology platform. As Lupin continues to expand its portfolio and explore strategic partnerships, this launch may serve as a springboard for future growth and innovation in the pharmaceutical industry.

Lupin Limited , a global pharmaceutical leader, has announced a significant milestone in its sustainability journey, achieving an S&P Global ESG Score of 91. This score represents a substantial improvement from 17 in 2021 and places Lupin among an elite group of companies worldwide that have surpassed the 90-point mark.

Industry-Leading Performance

The company's ESG score of 91 stands well above the pharmaceutical industry average of 28, highlighting Lupin's commitment to sustainable and responsible business practices. This achievement marks a 15-point increase from the previous year, establishing Lupin as a frontrunner in sustainable growth within the pharmaceutical sector.

Key Improvements Across ESG Pillars

Lupin has made significant strides across all three ESG pillars:

Environmental

• Increased use of renewable energy
• Successful reduction in carbon emissions
• Achievement of water-positive operations

Social

• Promotion of diversity and inclusion initiatives
• Launch of community health programs
• Significant contributions to societal healthcare

Governance

• Enhanced transparency in business practices
• Strengthened corporate governance
• Instituted board-level oversight for ESG-related risks and opportunities

Executive Perspective

Ramesh Swaminathan, Executive Director, Global CFO, and Head of IT and API Plus SBU at Lupin, commented on the achievement: "Achieving a score above 90 in the S&P Global ESG ratings is a rare global distinction, highlighting our unwavering commitment to sustainability. With a 15-point increase from last year, Lupin not only leads the pharmaceutical industry today but redefines and sets new standards for responsible growth."

Strategic Implications

This exceptional ESG performance is expected to have several positive implications for Lupin:

1. Enhanced reputation among stakeholders
2. Potential for improved access to capital from ESG-focused investors
3. Strengthened resilience against environmental and social risks
4. Alignment with global sustainability trends and regulatory expectations

Looking Ahead

As Lupin continues to integrate sustainability into its core business strategy, the company is well-positioned to maintain its leadership in responsible pharmaceutical practices. This achievement not only sets a new benchmark for the industry but also reinforces Lupin's commitment to creating lasting value for patients, communities, and stakeholders worldwide.

The company's focus on sustainable practices, coupled with its strong market position and innovative product pipeline, suggests a promising outlook for Lupin's long-term growth and impact in the global pharmaceutical landscape.