Lupin Launches Risperidone Long-Acting Injectable with 180-day CGT exclusivity in the U.S., the First Product from its Proprietary Long-Acting Injectable Platform PrecisionSphere™
Lupin Launches Risperidone Long-Acting Injectable with 180-day CGT exclusivity in the U.S., the First Product from its Proprietary Long-Acting Injectable Platform PrecisionSphere™ |
| [14-November-2025] |
MUMBAI, India and NAPLES, Fla., Nov. 14, 2025 /PRNewswire/ -- Global pharma major Lupin Limited (Lupin) (BSE: 500257) (NSE: LUPIN) (REUTERS: LUPIN.BO) (BLOOMBERG: LPCIN) today 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 PrecisionSphere™, 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 PrecisionSphere™ 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," 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." "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," said Dr. Fabrice Egros, President – Corporate Development, Lupin. "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." About the product Risperidone for extended-release injectable suspension is bioequivalent and therapeutically equivalent to the reference listed drug (RLD), Risperdal Consta® Long-Acting Injection, and is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. Risperidone for extended-release injectable suspension (RLD Risperdal Consta®) has estimated sales of USD 187 million combined for 25 mg, 37.5 mg and 50 mg in the U.S. (IQVIA MAT September 2025). About Lupin Lupin Limited is a global pharmaceutical leader headquartered in Mumbai, India, with products distributed in over 100 markets. Lupin specializes in pharmaceutical products, including branded and generic formulations, complex generics, biotechnology products, and active pharmaceutical ingredients. Trusted by healthcare professionals and consumers globally, the company enjoys a strong position in India and the U.S. across multiple therapy areas, including respiratory, cardiovascular, anti-diabetic, anti-infective, gastrointestinal, central nervous system, and women's health. Lupin has 15 state-of-the-art manufacturing sites and 7 research centers globally, along with a dedicated workforce of over 24,000 professionals. Lupin is committed to improving patient health outcomes through its subsidiaries - Lupin Diagnostics, Lupin Digital Health, and Lupin Manufacturing Solutions. To know more, visit www.lupin.com or follow us on LinkedIn https://www.linkedin.com/company/lupin To know more about Nanomi, visit www.nanomi.com or follow on LinkedIn https://www.linkedin.com/company/nanomi Logo: https://mma.prnewswire.com/media/2461104/Lupin_Logo.jpg
SOURCE Lupin Limited | ||
Company Codes: Bloomberg:LPCIN,Bombay:500257,Bombay:LUPIN.BO,India:LUPIN,India:LUPIN.NS,India:LUPIN-BL.NS,RICS:LUPIN.BO |
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