Mumbai: Global pharmaceutical major Lupin Limited has announced the U.S. launch of Risperidone for extended-release injectable suspension in 25 mg, 37.5 mg, and 50 mg single-dose vials. The product has been launched with 180-day Competitive Generic Therapy (CGT) exclusivity following recent approval from the United States Food and Drug Administration (U.S. FDA). This marks Lupin’s first commercial product developed using its proprietary long-acting injectable (LAI) platform, PrecisionSphere™, created by its Dutch subsidiary Nanomi B.V.
The launch represents a significant milestone in Lupin’s strategy to expand its complex generics portfolio and deliver differentiated therapies across therapeutic areas. PrecisionSphere™ technology enables the creation of uniform microspheres that offer extended-release drug delivery from weeks to months, superior injectability through smaller needles, and consistent drug concentration profiles. These features are designed to enhance patient compliance and therapeutic outcomes.
“The launch of Risperidone marks a significant milestone, demonstrating Lupin’s expertise in delivering complex injectables to market, validating the capabilities of the PrecisionSphere LAI technology platform,” said Spiro Gavaris, President, U.S. Generics at Lupin. “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.”
Dr. Fabrice Egros, President – Corporate Development at Lupin, added, “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. By leveraging our in-house expertise and alliance management, we are ready to expand patient access to advanced LAI treatments through our growing internal pipeline but also by forming new global strategic collaborations with companies that could benefit from longer-acting formulations for their products.”
Lupin’s entry into the LAI segment with Risperidone underscores its commitment to innovation in drug delivery and its ambition to become a global leader in complex generics. The company is actively seeking partnerships to extend the reach of its PrecisionSphere™ platform, enabling lifecycle extension for existing therapies and broader access to long-acting treatments.
