Amneal Pharmaceuticals Announces FDA Approval for Risperidone Extended-Release Injectable Suspension

Amneal Pharmaceuticals has received U.S. FDA approval for its risperidone extended-release injectable suspension in 12.5 mg, 25 mg, 37.5 mg, and 50 mg vials—marking a significant milestone in complex generic medicines and mental health care.

Key Details of the Press Release

• Date of Approval: September 4, 2025
• Product Reference: Janssen’s Risperdal Consta®
• FDA Exclusivity: Eligible for 180-day exclusivity under Competitive Generic Therapy (CGT)—giving Amneal first-mover advantage.
• Planned Launch: Q4 2025

Risperidone extended-release injectable suspension is an atypical antipsychotic indicated for the treatment of schizophrenia and as maintenance therapy (alone or adjunctive) for Bipolar I disorder with lithium or valproate.

Highlights & Strategic Impact

• Adds to Amneal’s growing portfolio of complex injectables, showcasing leadership in advanced R&D and manufacturing of complex pharmaceuticals.
• The product’s microsphere formulation and need for sophisticated cold-chain logistics demonstrate Amneal’s capability in specialized drug development.
• U.S. annual sales for generic risperidone extended-release injectables were approximately $194 million for the 12 months ended July 2025—a strong market opportunity.
• Amneal’s approval is expected to offer a cost-effective alternative and improve patient access in mental health treatment.

Clinical Information

• Indications: Schizophrenia; very effective alone or adjunctively for Bipolar I disorder maintenance therapy.
• Adverse Reactions: Headache, parkinsonism, dizziness, movement disorders, fatigue, constipation, indigestion, sedation, weight gain, limb pain, dry mouth.
• Special Manufacturing: Microsphere-based formulation and cold-chain manufacturing requirements.

About Amneal Pharmaceuticals

Amneal (Nasdaq: AMRX) is a global biopharma company headquartered in Bridgewater, NJ. The company develops and manufactures a diverse portfolio of over 280 medicines. Focus areas include complex generics, injectable therapies, biosimilars, and branded drugs mainly in central nervous system and endocrine disorders.

Investor and Media Contacts

• Investor Relations: Anthony DiMeo, VP, Investor Relations: anthony.dimeo@amneal.com
• Media Contact: Brandon Skop, Sr. Director, Corporate Communications: Brandon.skop@amneal.com

Read the Press Release of Amneal Pharma for Detailed Info

Amneal’s latest FDA approval strengthens its leadership position in complex generics and long-acting mental health treatments, increasing option for patients and healthcare providers, and opening further commercial growth.