Lupin launches generic injection in US with 180-day exclusivity

Drug maker Lupin on Friday said it has launched a generic medication to treat schizophrenia in the US with 180 days of exclusivity.

The company has launched Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, single-dose vials, with 180-day CGT exclusivity in the US, the Mumbai-based drug maker said in a statement.

This follows the recent approval received from the US Food and Drug Administration (USFDA).

This is the company's first product using proprietary technology from PrecisionSphere, the Long-acting Injectable (LAI) platform developed by its subsidiary Nanomi BV.

Risperidone for extended-release injectable suspension is bioequivalent and therapeutically equivalent to the reference listed drug Risperdal Consta LAI.

 

It is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder in adults.

As per IQVIA MAT September 2025 data, Risperidone for extended-release injectable suspension has estimated sales of USD 187 million combined for 25 mg, 37.5 mg and 50 mg in the US.

"It highlights our commitment to expanding our portfolio of differentiated, complex products, marking a significant step forward in our pursuit of developing novel long-acting injectables across diverse therapeutic areas," Lupin President US Generics Spiro Gavaris stated.

Shares of the drug maker were trading 0.37 per cent down at Rs 2,045.40 apiece on BSE.