Amneal Pharmaceuticals announced the FDA approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen’s Risperdal Consta®. The product is eligible for 180-day exclusivity under the FDA’s Competitive Generic Therapy (CGT) designation. Product launch is planned for the fourth quarter of 2025.
Risperidone extended-release injectable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia or may be used alone or as an adjunctive therapy with lithium or valproate for the maintenance treatment of Bipolar I disorder.
“This approval further strengthens our complex injectables portfolio with a new long-acting treatment option in mental health,” said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. “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.”
The most commonly reported adverse reactions for risperidone extended-release injectable suspension in clinical studies were headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight increased, pain in extremity, and dry mouth.
According to IQVIA® U.S. annual sales for risperidone extended-release injectable suspension for the 12 months ended July 2025 were approximately $194 million.
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