Risperidone Reinvented: Lupin Claims 180-Day Market Exclusivity in Major U.S. Drug Debut

Updated: November 14, 2025 08:31

Image Source : The Hindu Business Line

Lupin Limited has launched its Risperidone long-acting injectable suspension in the U.S., leveraging proprietary Nanomi technology. The product, available in 25 mg, 37.5 mg, and 50 mg single-dose vials, has secured 180-day competitive generic therapy (CGT) exclusivity, offering Lupin a significant market advantage. This injectable treats schizophrenia and bipolar I disorder.

Mumbai-based global pharmaceutical leader Lupin Limited has officially launched its Risperidone for extended-release injectable suspension in the U.S. market as of November 14, 2025. This marks a significant milestone as it is the first drug from Lupin’s Nanomi B.V. subsidiary platform, featuring proprietary Nanomi (PrecisionSphere™) technology for long-acting injectables (LAI). The product comes in single-dose vials of 25 mg, 37.5 mg, and 50 mg and is bioequivalent to the reference listed drug Risperdal Consta®.

Lupin has secured an exclusive 180-day market exclusivity granted by the U.S. Food and Drug Administration (FDA) under the Competitive Generic Therapy (CGT) designation. This exclusivity positions Lupin as the sole generic supplier for six months, which can drive significant market share and U.S. sales, with Risperidone’s estimated annual sales around USD 190 million.

The injectable suspension is indicated for schizophrenia and for maintenance treatment of bipolar I disorder as monotherapy or adjunctive therapy. It offers a long-acting treatment option to improve patient adherence and outcomes.

Executives highlighted the launch as a validation of Lupin’s technology and cross-functional capabilities in drug development and manufacturing. The company plans to leverage the Nanomi platform further for innovation in long-acting therapies across various therapeutic areas.

Key Highlights:

Lupin launches Risperidone long-acting injectable with 25 mg, 37.5 mg, and 50 mg dosages.

U.S. FDA has granted 180-day Competitive Generic Therapy exclusivity.

The drug is bioequivalent to Risperdal Consta® and treats schizophrenia and bipolar I disorder.

Launch is first product using Lupin’s proprietary Nanomi technology.

Estimated annual sales for reference product near USD 190 million in the U.S.

Enhances Lupin’s psychiatric medicine portfolio with advanced long-acting injectable options.

Leadership affirms the launch validates Lupin’s R&D and manufacturing capabilities.

Positioned to expand access to complex injectables globally.

Source: Lupin Limited press releases, PRNewswire, InvestyWise, Scanx Trade, ChemXpert