Lupin has launched its Risperidone long-acting injectable in the U.S., securing a 180-day CGT exclusivity. This marks the first product utilizing Lupin’s proprietary PrecisionSphere™ technology. The injectable is available in 25 mg, 37.5 mg, and 50 mg single-dose vials. This launch aims to improve treatment options for schizophrenia and bipolar disorder. The product has estimated sales of USD 187 million.
Risperidone Launch and Exclusivity
Lupin Limited announced the launch of Risperidone for extended-release injectable suspension in the U.S. on November 14, 2025. The product comes in 25 mg, 37.5 mg, and 50 mg single-dose vials and has been granted 180-day CGT exclusivity.
PrecisionSphere™ Technology
This launch represents the first product utilizing Lupin’s PrecisionSphere™ technology, a long-acting injectable (LAI) platform developed by Nanomi B.V., a Lupin subsidiary. The PrecisionSphere™ technology ensures consistent drug concentrations and superior injectability.
Management Commentary
Spiro Gavaris, President, U.S. Generics at Lupin, stated that the launch validates the capabilities of the PrecisionSphere LAI technology platform and highlights Lupin’s commitment to expanding its portfolio of differentiated products. Dr. Fabrice Egros, President – Corporate Development, Lupin, mentioned that this positions Lupin to expand global access to advanced long-acting injectable treatments.
Indication and Market
Risperidone for extended-release injectable suspension is indicated for the treatment of schizophrenia in adults and as monotherapy or adjunctive therapy for bipolar I disorder. The reference listed drug (RLD), Risperdal Consta®, has estimated sales of USD 187 million combined for the available dosages in the U.S. (IQVIA MAT September 2025).
Source: BSE