India's DMPLOI - Jobs & Networking App
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) today announced that the U.S. Food and Drug Administration (FDA) has approved risperidone extended-release injectable suspension in four dosage strengths: 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial, and 50 mg/vial. The product references Janssen’s Risperdal Consta® and is eligible for 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 indicated for the treatment of schizophrenia and as monotherapy or 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 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.”
Market Impact
According to IQVIA®, U.S. annual sales for risperidone extended-release injectable suspension for the 12 months ended July 2025 were approximately $194 million. With CGT exclusivity, Amneal is positioned to capture a significant share of this market.
Safety Profile
The most commonly reported adverse reactions observed in clinical studies included: headache, parkinsonism, dizziness, movement disorder, fatigue, constipation, indigestion, sedation, weight gain, extremity pain, and dry mouth. Full prescribing information is available in the product’s package insert.
About Amneal
Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ. With a portfolio of more than 280 pharmaceuticals, Amneal is dedicated to making healthy possible through its Affordable Medicines and Specialty segments. The company’s Affordable Medicines segment continues to expand in complex categories such as injectables and biosimilars, while its Specialty segment focuses primarily on central nervous system and endocrine disorders.
