Lupin Introduces New Risperidone LAI Backed by FDA Approval

Indian pharma major Lupin announced today the U.S. launch of Risperidone extended-release injectable suspension in 25 mg, 37.5 mg and 50 mg single-dose vials, marking a significant strategic move in the long-acting injectable (LAI) market.

The product is backed by 180-day CGT exclusivity, following approval from the U.S. Food & Drug Administration (FDA). In the first paragraph we highlight the keyword "Risperidone extended-release injectable suspension” to align with news coverage and search visibility.

This launch is the company’s first commercial product built on its proprietary PrecisionSphere platform, developed by its subsidiary Nanomi B.V.

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The PrecisionSphere technology enables uniform microsphere formation, delivering extended-release profiles spanning weeks to months, offering superior injectability with smaller needles and consistent drug concentrations. The use of such advanced platform in a risperidone LAI positions Lupin strongly in the specialty pharma space and signals its intent to grow beyond traditional generics.

From an industry perspective, the introduction of this risperidone extended-release injectable suspension enters a competitive LAI segment addressing serious psychiatric conditions, where patient adherence and dosing frequency matter significantly. The 180-day exclusivity window provides Lupin a meaningful head start in the U.S. market, offering payers and prescribers a novel branded alternative while generics are locked out.

Lupin's expansion of the PrecisionSphere technology via collaborations with other pharma firms adds further depth to its business model. The company is signaling that this risperidone extended-release injectable suspension is just the beginning of a technology-driven growth phase, positioning it as an innovation-oriented player in long-acting injectable therapeutics.