Lupin Secures USFDA Approval for Complex Risperidone Injectable, Validating its Nanomi Technology Platform

Global pharma major Lupin Limited has announced a significant regulatory milestone, having received final approval from the U.S. Food and Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Risperidone extended-release injectable suspension. The approval covers multiple strengths of the drug—25 mg, 37.5 mg, and 50 mg per vial—and marks a major victory for Lupin, as it is the very first product to be approved from its proprietary Nanomi long-acting injectable (LAI) platform.

The approval is particularly noteworthy as it includes a 180-day competitive generic therapy (CGT) exclusivity, a valuable period that will give Lupin an advantage in the market. The drug is indicated for the treatment of schizophrenia and for the maintenance treatment of bipolar I disorder as a monotherapy or in combination with other medications. The approved product is a bioequivalent version of the reference listed drug (RLD), Risperdal Consta® Long-Acting Injection, which has estimated annual sales of USD 190 million in the U.S.

The success of this approval is a testament to the advanced capabilities of Lupin’s subsidiary, Nanomi B.V. Nanomi’s proprietary particle control technology allows for the creation of uniform microspheres that enable a consistent and extended release of the drug over weeks or months. This innovative delivery method offers several benefits for patients, including superior injectability with smaller needles and the ability to maintain consistent drug concentrations in the body, which can improve adherence and overall health outcomes for individuals managing chronic conditions like schizophrenia and bipolar I disorder.

Lupin’s CEO, Vinita Gupta, expressed great satisfaction with the “first-cycle approval,” highlighting it as a validation of the company’s capabilities in developing complex injectables across its R&D and operational teams. Dr. Shahin Fesharaki, Lupin’s Chief Scientific Officer, echoed this sentiment, calling the approval a “critical milestone” that validates the Nanomi LAI technology platform and signals a significant step in the company’s journey to develop novel long-acting injectables for various therapeutic areas.