Amneal Pharmaceuticals Wins FDA Approval For Risperidone Extended-Release Injectable Suspension In Four Strengths With 180-Day CGT Exclusivity

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its risperidone extended-release injectable suspension in four strengths: 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial, and 50 mg/vial. The product references Janssen’s Risperdal Consta® and has been granted 180-day exclusivity under the FDA’s Competitive Generic Therapy (CGT) designation. Amneal plans to launch the product in the fourth quarter of 2025.

Arash Dabestani, Pharm.D., Senior Vice President, Institutional, stated, “This approval further strengthens our complex injectables portfolio with a new long-acting treatment option in mental health. Risperidone extended-release injectable suspension requires advanced capabilities such as microsphere formulation and cold-chain manufacturing that underscore Amneal’s leadership in developing and producing complex medicines. This milestone reflects our strong R&D and manufacturing expertise and lays the foundation for future microsphere-based long-acting injectables.”

Risperidone extended-release injectable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia and can also be used either alone or alongside lithium or valproate for the maintenance treatment of Bipolar I disorder. In clinical studies, the most frequently reported adverse reactions included headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight gain, pain in extremities, and dry mouth. Full prescribing information is available in the package insert. According to IQVIA, U.S. annual sales for risperidone extended-release injectable suspension for the 12 months ending July 2025 were approximately $194 million.