Lupin Gets USFDA Nod for Generic Risperidone Extended-Release Injectable Suspension

Pharma major Lupin Ltd on Wednesday said it has received approval from the US health regulator for its generic version of risperidone for extended-release injectable suspension, used in the treatment and maintenance of schizophrenia and bipolar disorder in adults.

The approval 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.

"This is Lupin's first product using proprietary Nanomi BV's (Nanomi) technology and has a 180-day CGT (competitive generic therapies) exclusivity," it added.

Nanomi, a Lupin subsidiary, is focused on the development of innovative long-acting injectable (LAI) medicines to improve health outcomes for patients, the company said.

Lupin CEO Vinita Gupta said this is the approval of the first product from the Nanomi LAI platform.

"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," she added.

Gupta further said, "As we execute on our strategy to evolve speciality/novel products, we plan to leverage the Nanomi platform for novel long-acting injectables that meet unmet patient needs".

Nanomi's LAI platform has demonstrated efficacy and safety in drug delivery. The 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.