Amneal Pharmaceuticals Secures FDA Approval for Risperidone Extended-Release Injectable Suspension
Amneal Pharmaceuticals, Inc. (NASDAQ: AMRX) has announced a significant milestone with the U.S. Food and Drug Administration (FDA) granting approval for its risperidone extended-release injectable suspension. This new product, available in 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial, and 50 mg/vial dosages, is a generic alternative to Janssen’s Risperdal Consta® and has been awarded 180-day exclusivity under the FDA’s Competitive Generic Therapy (CGT) designation. Amneal plans to launch the product in the fourth quarter of 2025.
Risperidone extended-release injectable suspension is an atypical antipsychotic used to treat schizophrenia. It can also be administered alone or alongside 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 at Amneal. “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 side effects observed in clinical studies for risperidone extended-release injectable suspension include headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight gain, pain in extremities, and dry mouth. For detailed prescribing information, refer to the product’s package insert.
According to IQVIA®, U.S. annual sales for risperidone extended-release injectable suspension reached approximately $194 million for the 12 months ending July 2025.
About Amneal Pharmaceuticals
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company committed to making healthcare accessible. The company boasts a diverse portfolio of over 280 pharmaceuticals, primarily serving the U.S. market. Amneal’s Affordable Medicines segment focuses on a wide range of complex product categories and therapeutic areas, including injectables and biosimilars. Its Specialty segment features a growing portfolio of branded pharmaceuticals targeting central nervous system and endocrine disorders. Additionally, through its AvKARE segment, Amneal serves as a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets.
