Amneal Pharmaceuticals Receives FDA Approval for Risperidone Extended-Release Injectable Suspension, Expanding Complex Injectables Portfolio

Amneal Pharmaceuticals has received FDA approval for risperidone extended-release injectable suspension, a treatment for schizophrenia and bipolar disorder. The product is eligible for 180-day exclusivity under the FDA's Competitive Generic Therapy designation. Launch is planned for Q4 2025. The approval strengthens Amneal's complex injectables portfolio and highlights the company's leadership in developing and producing complex medicines.

Amneal Pharmaceuticals, Inc. (AMRX) has received a significant milestone with the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension, a treatment for schizophrenia and bipolar disorder. The product, which references Janssen’s Risperdal Consta®, is eligible for 180-day exclusivity under the FDA’s Competitive Generic Therapy (CGT) designation. The 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. The product requires advanced capabilities such as microsphere formulation and cold-chain manufacturing, underscoring Amneal’s leadership in developing and producing complex medicines.

Arash Dabestani, Pharm.D., Senior Vice President, Institutional at Amneal, 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 that underscore our 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. For full prescribing information, see the package insert here.

According to IQVIA® U.S. annual sales for risperidone extended-release injectable suspension for the 12 months ended July 2025 were approximately $194 million.

Amneal Pharmaceuticals, Inc., headquartered in Bridgewater, NJ, is a global biopharmaceutical company that develops, manufactures, and distributes a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. The company is expanding its portfolio in complex injectables and biosimilars, as well as specialty pharmaceuticals focused on central nervous system and endocrine disorders.

References:
[1] https://www.stocktitan.net/news/AMRX/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-3t3gg7k7ke95.html
[2] https://stocktwits.com/news-articles/markets/equity/lupin-gains-after-usfda-nod-for-injectable-to-treat-schizophrenia-and-bipolar-i-disorder/chwTtqfRd8J
[3] https://www.marketscreener.com/news/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-injectable-suspension-ce7d59d8dc80f024