Lupin Receives U.S. FDA Approval for Risperidone Long-Acting Injectable with 180-Day CGT Exclusivity

Global pharma major Lupin Limited has received approval from the U.S. FDA for its Abbreviated New Drug Applications (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. This is Lupin’s first product using proprietary Nanomi B.V.’s (Nanomi) technology and has a 180-day CGT exclusivity. Risperidone for extended-release injectable suspension is bioequivalent to the reference listed drug (RLD), 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. Risperdal Consta® had estimated annual sales of USD 190 million in the U.S. (IQVIA MAT July 2025).