Amneal Receives U.S. FDA Approval for Bimatoprost Ophthalmic Solution, 0.01%
Amneal Pharmaceuticals (NYSE:AMRX) has received FDA approval for its generic version of bimatoprost ophthalmic solution 0.01%, equivalent to LUMIGAN®. The treatment, indicated for reducing elevated intraocular pressure in patients with open-angle glaucoma or ocular hypertension, represents a significant addition to Amneal's Affordable Medicines portfolio.
The approval covers multiple sizes (2.5 mL, 5 mL and 7.5 mL) of the solution. According to IQVIA® data, the reference product generated approximately $685 million in U.S. annual sales for the 12 months ended July 2025, highlighting substantial market opportunity for Amneal.
Amneal Pharmaceuticals (NYSE:AMRX) ha ottenuto l'approvazione FDA per la versione generica della soluzione oculare di bimatoprost 0,01%, equivalente a LUMIGAN®. Il trattamento, indicato per ridurre la pressione intraoculare elevata nei pazienti con glaucoma ad angolo aperto o ipertensione oculare, rappresenta un importante arricchimento del portafoglio di Medicinali Accessibili di Amneal.
L'approvazione comprende diverse confezioni (2,5 mL, 5 mL e 7,5 mL) della soluzione. Secondo i dati IQVIA®, il prodotto di riferimento ha generato circa 685 milioni di dollari di vendite annue negli Stati Uniti nei 12 mesi conclusi a luglio 2025, evidenziando un'enorme opportunità di mercato per Amneal.
Amneal Pharmaceuticals (NYSE:AMRX) ha obtenido la aprobación de la FDA para su versión genérica de la solución oftálmica de bimatoprost 0,01%, equivalente a LUMIGAN®. El tratamiento, indicado para reducir la presión intraocular elevada en pacientes con glaucoma de ojo abierto o hipertensión ocular, representa una adición significativa a la cartera de Medicamentos Asequibles de Amneal.
La aprobación cubre varias presentaciones (2,5 mL, 5 mL y 7,5 mL) de la solución. Según datos de IQVIA®, el producto de referencia generó aproximadamente 685 millones de dólares en ventas anuales en Estados Unidos durante los 12 meses finalizados en julio de 2025, destacando una sustancial oportunidad de mercado para Amneal.
Amneal Pharmaceuticals (NYSE:AMRX)가 LUMIGAN®에 해당하는 바다토프로스트 0.01% 점안용 용액의 제네릭 버전에 대해 FDA 승인을 받았습니다. 이 치료법은 전방각녹내장이나 안압 상승으로 인한 고안된 혀인으로, Amneal의 합리적 의약품 포트폴리오에 중요한 추가가 됩니다.
승인은 2.5 mL, 5 mL, 7.5 mL의 여러 용량을 포함합니다. IQVIA® 데이터에 따르면 기준 의약품은 2025년 7월까지 12개월 동안 미국에서 약 6억8500만 달러의 연간 매출을 기록했으며, 이는 Amneal에 큰 시장 기회를 시사합니다.
Amneal Pharmaceuticals (NYSE:AMRX) a reçu l'approbation de la FDA pour sa version générique de la solution oculaire de bimatoprost à 0,01%, équivalente à LUMIGAN®. Le traitement, indiqué pour réduire une pression intraoculaire élevée chez les patients atteints de glaucome à angle ouvert ou d'hypertension oculaire, constitue un ajout important au portefeuille Médicaments Abordables d'Amneal.
L'approbation couvre plusieurs formats (2,5 mL, 5 mL et 7,5 mL) de la solution. Selon les données IQVIA®, le produit de référence a généré environ 685 millions de dollars de ventes annuelles aux États‑Unis sur les 12 mois clos en juillet 2025, soulignant une opportunité de marché substantielle pour Amneal.
Amneal Pharmaceuticals (NYSE:AMRX) hat von der FDA die Zulassung für seine generische Version der Bimatopost-Augenlösung 0,01% erhalten, die LUMIGAN® gleichwertig ist. Die Behandlung, vorgesehen zur Reduktion erhöhten Augeninnendrucks bei Patienten mit offenem Winkelglaukom oder okulärer Hypertension, stellt eine bedeutende Ergänzung zum Portfolio Bezahlbare Medikamente von Amneal dar.
Die Zulassung umfasst mehrere Größen (2,5 mL, 5 mL und 7,5 mL) der Lösung. Laut IQVIA®-Daten erzielte das Referenzprodukt in den USA in den 12 Monaten bis Juli 2025 ca. 685 Millionen US-Dollar an Jahresumsatz, was eine erhebliche Marktchance für Amneal verdeutlicht.
شركات أمهان للأدوية (NYSE:AMRX) حصلت على موافقة إدارة الغذاء والدواء الأمريكية لنوعها الجنيري من حل العين ببماطورست 0.01%، ما يعادل LUMIGAN®. يُشير العلاج، المخصص لـ خفض الضغط داخل العين المرتفع لدى مرضىGlaucoma بقزحية مفتوحة أو ارتفاع الضغط في العين، إلى إضافة مهمة إلى مجموعة الأدوية الميسورة التكلفة لدى أم نيال.
تشمل الموافقة أحجام متعددة (2.5 مل، 5 مل و7.5 مل) من المحلول. وفق بيانات IQVIA®، حققت المنتج المرجعي قرابة 685 مليون دولار من المبيعات السنوية في الولايات المتحدة خلال 12 شهرًا المنتهية في يوليو 2025، مما يبرز فرصة سوق كبيرة أمام أم نيال.
Amneal Pharmaceuticals（NYSE:AMRX） 已获得 FDA 批准其0.01%β-促前列腺的眼用溶液的仿制药，与 LUMIGAN® 相当。该治疗用于
批准覆盖该溶液的多种规格（2.5 mL、5 mL、7.5 mL）。根据 IQVIA® 数据，参考药物在截至 2025 年 7 月的过去 12 个月在美国的年销售额约为 $6.85 亿，这凸显了 Amneal 的巨大市场潜力。
- FDA approval received for generic version of LUMIGAN® with $685M market opportunity
- Product will be key growth driver for Amneal's Affordable Medicines segment
- Multiple product sizes approved (2.5 mL, 5 mL and 7.5 mL) offering flexibility in treatment options
- Most common adverse reaction reported is conjunctival hyperemia
Important ophthalmic treatment for patients and expected to be a key growth driver for Amneal’s Affordable Medicines segment
BRIDGEWATER, N.J., Sept. 23, 2025 (GLOBE NEWSWIRE) -- Amneal Pharmaceuticals, Inc. (“Amneal” or the “Company”) today announced that the U.S. Food and Drug Administration (FDA) has approved the Company’s Abbreviated New Drug Application (ANDA) for bimatoprost ophthalmic solution
Bimatoprost ophthalmic solution
“We are pleased to add another key ophthalmic therapy to our Affordable Medicines portfolio,” said Dr. Srinivas Kone, Senior Vice President, Chief Scientific Officer – Affordable Medicines. “As the prevalence of glaucoma continues to rise, particularly among the aging population, it is critical that patients and providers have affordable access to effective treatments such as bimatoprost. This represents our most recent complex new product approval this year and an important growth driver for our Affordable Medicines segment.”
The most common adverse reaction associated with bimatoprost ophthalmic solution
According to IQVIA® U.S. annual sales for bimatoprost ophthalmic solution
Note: LUMIGAN® is a registered trademark of Allergan, Inc., an AbbVie company.
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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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.
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