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04 Sep 2025
Admin
News Article

Lupin Wins US FDA Approval for Long-Acting Risperidone Injection with 180-Day Exclusivity

Lupin Limited has secured US FDA approval for its risperidone extended-release injectable suspension (25 mg, 37.5 mg, and 50 mg single-dose vials). This marks Lupin’s first product using subsidiary Nanomi B.V.’s proprietary long-acting injectable (LAI) technology and comes with 180-day CGT exclusivity.

Why This Matters

First-cycle approval: Demonstrates Lupin’s execution strength in complex injectables.
Validation of Nanomi’s LAI platform: Proprietary particle control technology enables:
- Uniform microspheres for extended-release (weeks to months).
- Superior injectability with smaller needles.
- Stable drug concentration profiles.
Strategic impact: Expands Lupin’s specialty/novel product pipeline and strengthens presence in the long-acting injectable space.

Leadership Commentary

Vinita Gupta, CEO, Lupin:

“This approval validates our Nanomi LAI platform and reinforces our commitment to expand access to complex injectables worldwide. We plan to leverage this platform for novel long-acting therapies to address unmet needs.”

Dr. Shahin Fesharaki, CSO, Lupin:

“Risperidone’s FDA approval is a critical milestone that showcases our cross-functional strengths and opens the door for further LAI innovation.”

Product Details

Indications:
- Treatment of schizophrenia.
- Monotherapy or adjunctive therapy to lithium or valproate for maintenance of bipolar I disorder.
Reference Listed Drug (RLD): Risperdal Consta® (Johnson & Johnson).
Bioequivalence: Lupin’s risperidone matches the safety and efficacy of the branded injectable.

About Nanomi’s LAI Technology

Nanomi’s proprietary microsphere platform enables:

Precise particle control for predictable release.
Longer dosing intervals, improving patient adherence.
Potential lifecycle extension for existing drugs by converting them into long-acting formulations.

About Lupin

Lupin is a global pharma leader with expertise spanning branded, generics, and specialty medicines. With this FDA approval, Lupin advances its mission of delivering affordable, complex therapies across critical therapeutic areas, while expanding into next-generation injectables through Nanomi’s technology.

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