Global pharma major Lupin has launched Risperidone for extended-release injectable suspension (25 mg, 37.5 mg and 50 mg single-dose vials) with 180-day CGT exclusivity in the United States, following recent approval from the US Food and Drug Administration (US FDA).

The product is bioequivalent and therapeutically equivalent to Risperdal Consta Long-Acting Injection. It is indicated for the treatment of schizophrenia in adults, and for the maintenance treatment of bipolar I disorder in adults, either as monotherapy or as an adjunct to lithium or valproate.

The launch marks Lupin’s first commercial product using PrecisionSphere, the proprietary long-acting injectable (LAI) platform developed by its subsidiary Nanomi. The technology creates uniform microspheres that deliver extended-release profiles from weeks to months, superior injectability through smaller needles and consistent drug concentrations.  

Lupin said it is expanding the reach of its PrecisionSphere technology by fostering collaborations with companies looking to extend their product lifecycles.  

Spiro Gavaris, President of US Generics at Lupin, described the launch as a “significant milestone,” demonstrating the company’s expertise in delivering complex injectables to market and 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,” he said.

Dr. Fabrice Egros, President – Corporate Development, Lupin, added that PrecisionSphere’s proven capabilities, combined with the company’s track record of successful partnerships, uniquely position Lupin 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,” he noted.

Lupin holds a strong market presence in India and the US across therapeutic categories such as respiratory, cardiovascular, diabetes, anti-infective, gastrointestinal, central nervous system and women’s health. The company operates 15 manufacturing facilities and seven research centres worldwide.