Amneal Receives U.S. FDA Approval for Risperidone Extended-Release Injectable Suspension
Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for risperidone extended-release injectable suspension in multiple dosage strengths (12.5 mg, 25 mg, 37.5 mg, and 50 mg/vial), a generic version of Janssen's Risperdal Consta®. The product, which received Competitive Generic Therapy (CGT) designation with 180-day exclusivity, will be launched in Q4 2025.
The injectable suspension, designed for treating schizophrenia and Bipolar I disorder, demonstrates Amneal's expertise in complex pharmaceuticals, particularly in microsphere formulation and cold-chain manufacturing. The reference product generated approximately $194 million in U.S. annual sales for the 12 months ended July 2025, according to IQVIA®.
Amneal Pharmaceuticals (NYSE:AMRX) ha ottenuto l'approvazione della FDA per una sospensione iniettabile a rilascio prolungato di risperidone in più dosaggi (12,5 mg, 25 mg, 37,5 mg e 50 mg/flacone), versione generica del Risperdal Consta® di Janssen. Il prodotto, cui è stata attribuita la designazione Competitive Generic Therapy (CGT) con un periodo di esclusività di 180 giorni, sarà lanciato nel Q4 2025.
La sospensione iniettabile, indicata per la trattamento della schizofrenia e del disturbo bipolare di tipo I, mette in evidenza le competenze di Amneal nei farmaci complessi, in particolare nella formulazione a microsfere e nella produzione con catena del freddo. Il prodotto di riferimento ha registrato circa $194 milioni di vendite annue negli Stati Uniti nei 12 mesi conclusi a luglio 2025, secondo IQVIA®.
Amneal Pharmaceuticals (NYSE:AMRX) ha recibido la aprobación de la FDA para una suspensión inyectable de risperidona de liberación prolongada en varias concentraciones (12,5 mg, 25 mg, 37,5 mg y 50 mg/vial), una versión genérica del Risperdal Consta® de Janssen. El producto, que obtuvo la designación Competitive Generic Therapy (CGT) con 180 días de exclusividad, se lanzará en el Q4 2025.
La suspensión inyectable, indicada para el tratamiento de la esquizofrenia y el trastorno bipolar tipo I, refleja la experiencia de Amneal en productos farmacéuticos complejos, especialmente en formulaciones de microesferas y fabricación con cadena de frío. El producto de referencia generó aproximadamente $194 millones en ventas anuales en EE. UU. en los 12 meses finalizados en julio de 2025, según IQVIA®.
Amneal Pharmaceuticals (NYSE:AMRX)가 여러 투여량(12.5 mg, 25 mg, 37.5 mg, 50 mg/바이알)의 리스페리돈 서방형 주사 현탁액에 대해 FDA 승인을 받았습니다. 이는 Janssen의 Risperdal Consta®의 복제약입니다. 해당 제품은 Competitive Generic Therapy (CGT) 지정을 받아 180일의 독점권을 부여받았으며, Q4 2025에 출시될 예정입니다.
이 주사 현탁액은 정신분열증(조현병) 및 양극성 장애 I형 치료용으로 설계되었으며, 미세구체(microsphere) 제형과 콜드체인 제조 분야에서 Amneal의 복잡한 의약품 전문성을 보여줍니다. 기준 제품은 IQVIA®에 따르면 2025년 7월 종료된 12개월 동안 미국에서 약 $194 million의 연매출을 기록했습니다.
Amneal Pharmaceuticals (NYSE:AMRX) a obtenu l'approbation de la FDA pour une suspension injectable à libération prolongée de rispéridone en plusieurs dosages (12,5 mg, 25 mg, 37,5 mg et 50 mg/flacon), une version générique du Risperdal Consta® de Janssen. Le produit, qui a reçu la désignation Competitive Generic Therapy (CGT) avec une exclusivité de 180 jours, sera lancé au Q4 2025.
La suspension injectable, destinée au traitement de la schizophrénie et du trouble bipolaire de type I, illustre l'expertise d'Amneal dans les produits pharmaceutiques complexes, notamment en formulation de microbilles et en fabrication en chaîne du froid. Le produit de référence a généré environ $194 millions de ventes annuelles aux États-Unis pour les 12 mois clos en juillet 2025, d'après IQVIA®.
Amneal Pharmaceuticals (NYSE:AMRX) hat die FDA-Zulassung für eine risperidon-Depot-Injektionssuspension mit verlängerter Wirkstofffreisetzung in mehreren Dosierungen (12,5 mg, 25 mg, 37,5 mg und 50 mg/Fläschchen) erhalten – eine Generikaversion von Janssens Risperdal Consta®. Das Produkt, dem die Bezeichnung Competitive Generic Therapy (CGT) mit 180-tägiger Exklusivität zuerkannt wurde, soll im Q4 2025 auf den Markt kommen.
Die Injektionssuspension, vorgesehen zur Behandlung von Schizophrenie und bipolarer Störung Typ I, unterstreicht Amneals Expertise bei komplexen Arzneimitteln, insbesondere in der Microsphere-Formulierung und der Herstellung in der Kühlkette. Das Referenzprodukt erzielte laut IQVIA® in den 12 Monaten bis Juli 2025 in den USA etwa $194 Millionen Jahresumsatz.
- Received FDA approval with 180-day exclusivity under CGT designation
- Targeting $194 million market opportunity based on current annual sales
- Demonstrates advanced manufacturing capabilities in complex injectables
- Launch planned for Q4 2025, expanding mental health treatment portfolio
- Multiple adverse reactions reported in clinical studies including headache, parkinsonism, and dizziness
- Requires complex cold-chain manufacturing and distribution infrastructure
Insights
Amneal gains FDA approval for complex generic risperidone injectable with 180-day market exclusivity, targeting $194M market opportunity.
Amneal Pharmaceuticals has secured FDA approval for risperidone extended-release injectable suspension, a generic version of Janssen's Risperdal Consta®, with planned launch in Q4 2025. This approval represents a significant opportunity for Amneal, as the referenced product generated approximately
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.
What makes this approval particularly notable is the complexity of the product. Risperidone extended-release injectable 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 complex injectables segment represents a strategic growth area for generic manufacturers, as these products face less competition and price erosion compared to oral solid dosage forms. Amneal's success in navigating the regulatory pathway for this complex product also positions the company favorably for future microsphere-based long-acting injectable approvals.
- 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
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 and follow us on LinkedIn.
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