Amneal To Launch Generic Risperidone Consta® In Q4 2025 Following FDA Approval

Amneal Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved its risperidone extended-release injectable suspension in four vial strengths (12.5 mg, 25 mg, 37.5 mg, and 50 mg). 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.

“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,” said Arash Dabestani, Pharm.D., Senior Vice President, Institutional. 

The therapy is an atypical antipsychotic approved for the treatment of schizophrenia and for use alone or alongside lithium or valproate in the maintenance treatment of Bipolar I disorder. Clinical studies of risperidone extended-release injectable suspension have reported side effects such as headache, dizziness, Parkinsonism, movement disorders, sedation, constipation, weight gain, indigestion, and fatigue.

According to IQVIA® data, U.S. annual sales of risperidone extended-release injectable suspension were approximately $194 million for the 12 months ending July 2025. Amneal’s entry into the market with FDA exclusivity is expected to provide patients and providers with an alternative while potentially lowering healthcare costs.