Amneal Pharmaceuticals receives FDA approval for risperidone injectable suspension, enhancing its complex injectables portfolio. Launch planned for Q4 2025.
Quiver AI Summary
Amneal Pharmaceuticals announced the FDA approval of its risperidone extended-release injectable suspension, available in 12.5 mg, 25 mg, 37.5 mg, and 50 mg vials, which is a generic version of Janssen's Risperdal Consta®. This product, eligible for 180-day exclusivity under the FDA's Competitive Generic Therapy designation, is expected to launch in the fourth quarter of 2025. It serves as an atypical antipsychotic for treating schizophrenia and maintaining Bipolar I disorder. Amneal emphasizes its advanced manufacturing capabilities for this complex medication, highlighting their expertise in R&D and production. The approval aligns with the company's strategy to expand its injectables portfolio, particularly in mental health treatments, with annual sales for the injectable suspension estimated at approximately $194 million.
Potential Positives
- FDA approval of risperidone extended-release injectable suspension expands Amneal's complex injectables portfolio, demonstrating its leadership in advanced pharmaceutical development.
- The product is eligible for 180-day exclusivity under the FDA’s Competitive Generic Therapy designation, potentially leading to a competitive advantage and increased market share.
- Projected annual U.S. sales of approximately $194 million for risperidone extended-release injectable suspension highlight significant revenue potential for Amneal.
- The approval reinforces Amneal's capabilities in developing complex medicines, laying the foundation for future microsphere-based long-acting injectables.
Potential Negatives
- The press release highlights a range of common adverse reactions associated with the new product, which may raise concerns about its safety profile among healthcare providers and patients.
- Amneal's reliance on the FDA's Competitive Generic Therapy (CGT) designation for market exclusivity may indicate challenges in differentiating its product from competitors in the market.
- The mention of various forward-looking statements introduces a level of uncertainty regarding the company's future operations and financial performance.
FAQ
What did Amneal Pharmaceuticals announce on September 4, 2025?
Amneal announced FDA approval of risperidone extended-release injectable suspension in multiple dosages, enhancing its injectables portfolio.
What is the indication for risperidone extended-release injectable suspension?
This medication is indicated for the treatment of schizophrenia and as maintenance therapy for Bipolar I disorder.
When will the new risperidone injectable be launched?
The product launch is planned for the fourth quarter of 2025.
What are common side effects of risperidone extended-release injectable suspension?
Common side effects include headache, dizziness, fatigue, weight gain, and dry mouth, among others.
How does risperidone extended-release suspension reflect Amneal's capabilities?
This approval showcases Amneal's expertise in advanced development and manufacturing of complex pharmaceuticals.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
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Full Release
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Another addition to Amneal’s growing complex injectables portfolio reflects leadership in advanced development and manufacturing of complex pharmaceuticals
BRIDGEWATER, N.J., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced the U.S. Food and Drug Administration (FDA) approval of risperidone extended-release injectable suspension 12.5 mg/vial, 25 mg/vial, 37.5 mg/vial and 50 mg/vial, which references Janssen’s Risperdal Consta ® . The product is eligible for 180-day exclusivity under the FDA’s Competitive Generic Therapy (CGT) designation. Product 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.
“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. “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 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.
About Amneal
Amneal Pharmaceuticals, Inc. (Nasdaq: AMRX), headquartered in Bridgewater, NJ, is a global biopharmaceutical company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of over 280 pharmaceuticals, primarily within the United States. In its Affordable Medicines segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit
www.amneal.com
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Cautionary Statement on Forward-Looking Statements
Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations; expected or estimated operating results and financial performance; and statements regarding our positioning, including our ability to drive sustainable long-term growth, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.
Investor Contact
Anthony DiMeo
VP, Investor Relations
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Media Contact
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Sr. Director, Corporate Communications
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