By: IPP Bureau
Last updated : November 17, 2025 11:16 am
This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology
Lupin Limited has officially launched Risperidone extended-release injectable suspension in the US, offering 25 mg, 37.5 mg, and 50 mg single-dose vials. The launch comes after the product received US FDA approval and secures Lupin 180 days of first-to-market exclusivity.
This marks Lupin’s first commercial product leveraging PrecisionSphere, a proprietary long-acting injectable (LAI) technology developed by its subsidiary, Nanomi B.V. The platform delivers uniform microspheres that enable extended drug release over weeks to months, improved injectability through smaller needles, and consistent therapeutic levels. Lupin plans to expand PrecisionSphere’s reach through collaborations aimed at extending product lifecycles for other drugs.
“The launch of Risperidone represents a major milestone for Lupin, showcasing our ability to bring complex injectables to market and validating the PrecisionSphere LAI platform,” said Spiro Gavaris, President, US Generics, at Lupin. “It underscores our commitment to growing a portfolio of differentiated, complex therapies and advancing novel long-acting injectables across multiple therapeutic areas.”
Dr Fabrice Egros, President – Corporate Development, added, “PrecisionSphere’s proven capabilities, coupled with our successful track record of partnerships, uniquely position us to expand global access to advanced long-acting injectable treatments. We aim to leverage both our internal pipeline and strategic collaborations to bring longer-acting therapies to patients worldwide.”
Risperidone extended-release injectable is bioequivalent and therapeutically equivalent to the reference-listed drug Risperdal Consta. It is indicated for the treatment of schizophrenia in adults, as well as for maintenance treatment of bipolar I disorder in adults, either as monotherapy or adjunctive therapy with lithium or valproate, as per the release.
With this launch, Lupin steps firmly into the growing market for complex long-acting injectables, combining innovative technology with a strategic push to enhance patient access and improve adherence in psychiatric care.