Amneal Pharmaceuticals Receives FDA Approval for Antipsychotic Medicine

Amneal Pharmaceuticals has received FDA approval for an antipsychotic medicine, expanding its portfolio of essential medicines. The company's Generics segment includes over 270 product families, while its Specialty segment focuses on branded pharmaceuticals for central nervous system disorders. The AvKARE segment provides pharmaceuticals, medical and surgical products to governmental agencies.

Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX) has received U.S. Food and Drug Administration (FDA) approval for its risperidone extended-release injectable suspension, a generic version of Janssen's Risperdal Consta®. This approval expands Amneal's portfolio of essential medicines, particularly in the mental health treatment space. The product is available in dosages of 12.5 mg, 25 mg, 37.5 mg, and 50 mg per vial and is indicated for the treatment of schizophrenia and Bipolar I disorder.

The approval comes with a valuable 180-day exclusivity period under the FDA's Competitive Generic Therapy (CGT) designation, giving Amneal a temporary competitive advantage in this specialized market. This exclusivity window could translate to substantial revenue capture during the initial commercialization phase. The product is expected to launch in the fourth quarter of 2025.

Risperidone extended-release injectable suspension requires sophisticated manufacturing capabilities, including microsphere formulation and cold-chain production—technical barriers that limit potential competition. These advanced capabilities highlight Amneal's growing expertise in complex pharmaceuticals, which typically command higher margins than conventional generics. This approval strengthens Amneal's position in the mental health treatment space, specifically for schizophrenia and bipolar I disorder maintenance therapy.

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.

According to IQVIA®, U.S. annual sales for risperidone extended-release injectable suspension for the 12 months ended July 2025 were approximately $194 million. This represents a significant opportunity for Amneal, given the reference product's market performance.

Amneal Pharmaceuticals is a global biopharmaceutical company headquartered in Bridgewater, NJ. It operates through three segments: Generics, Specialty, and AvKARE. The Generics segment includes over 270 product families, while the Specialty segment focuses on branded pharmaceuticals for central nervous system disorders. The AvKARE segment provides pharmaceuticals, medical, and surgical products to governmental agencies.

References:
[1] https://finance.yahoo.com/news/amneal-receives-u-fda-approval-200100283.html
[2] https://seekingalpha.com/news/4492523-amneal-gets-fda-nod-for-generic-version-of-risperdal-consta
[3] https://www.stocktitan.net/news/AMRX/amneal-receives-u-s-fda-approval-for-risperidone-extended-release-3t3gg7k7ke95.html