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Lupin launches risperidone long-acting injectable with 180-day CGT exclusivity in the US, the first product from its proprietary long-acting injectable platform

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a syringe filled with light blue liquid

Global pharma major Lupin Limited announced the launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, Single-Dose Vials, with 180-day CGT exclusivity in the U.S.

This follows the recent approval received from the United States Food and Drug Administration (U.S. FDA). This is Lupin’s first product using proprietary technology from PrecisionSphereTM, the long-acting injectable (LAI) platform developed by Lupin’s subsidiary Nanomi B.V.’s (Nanomi).

Nanomi’s LAI platform has demonstrated efficacy and safety in drug delivery. Its proprietary PrecisionSphereTM technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles, and consistent drug concentrations. Lupin is expanding the reach of its PrecisionSphere™ technology by fostering collaborations with companies looking to extend their product lifecycles.

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. 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.

said Spiro Gavaris, President, U.S. Generics at Lupin. 

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.

said Dr. Fabrice Egros, President – Corporate Development, Lupin. 

For more information, read the original press release.

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