Indian pharmaceutical major, Lupin Ltd, said on Wednesday it received approval from the US health regulator for the generic version of risperidone for extended-release injectable suspension, used in the treatment and maintenance of schizophrenia and bipolar disorder in adults.
The nod by the US Food and Drug Administration (USFDA) is for the abbreviated new drug application (ANDA) for risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials, Lupin said in a regulatory filing.
The pharma company’s CEO, Vinita Gupta, said this approval is of the first product from their Nanomi LAI platform, a Lupin subsidiary that is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients.
The product has a 180-day CGT (competitive generic therapies) exclusivity, the company has informed.
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"This first-cycle approval is a testament to the capabilities we have established for complex injectables across our teams in R&D, operations and related functions. It validates our platform capabilities at Nanomi and underscores our commitment to expanding access to complex injectables for patients globally," Gupta added.
The Nanomi's technology can provide lifecycle extension opportunities for products in development or on the market that would benefit from longer-acting formulations, the company said.
Risperidone for extended-release injectable suspension is bioequivalent to the reference-listed drug, Risperdal Consta long-acting injection, and is indicated for the treatment of schizophrenia and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder.
The medicine had estimated annual sales of USD 190 million in the US, Lupin said, citing IQVIA MAT July 2025 data.
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