Lupin receives FDA approval for novel injectable Risperidone

Lupin Limited announced it received U.S. FDA approval for its Abbreviated New Drug Applications (ANDA) for Risperidone extended-release injectable suspension in 25 mg, 37.5 mg, and 50 mg per vial, single-dose vials. This approval includes 180-day Competitive Generic Therapy (CGT) exclusivity and represents the first product leveraging Lupin's Nanomi B.V. technology.

The newly approved Risperidone is bioequivalent to Risperdal Consta® Long-Acting Injection and is indicated for schizophrenia treatment, as well as monotherapy or adjunctive therapy for bipolar I disorder. Risperdal Consta® had estimated annual sales of $190 million in the U.S. as of IQVIA MAT July 2025.

According to Vinita Gupta, chief executive of Lupin, this first-cycle approval validates the capabilities established for complex injectables and underscores the company's commitment to expanding patient access globally. Dr. Shahin Fesharaki, chief scientific officer, highlighted the approval as a critical milestone affirming Nanomi's LAI technology platform and Lupin's ability to commercialize complex injectables.