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 0.01% (2.5 mL, 5 mL and 7.5 mL). The product is the generic equivalent of LUMIGAN® (bimatoprost ophthalmic solution) 0.01%, whose design is a trademark of Allergan, Inc., an AbbVie company. Bimatoprost ophthalmic solution 0.01% is a ...

Core Insights - Amneal Pharmaceuticals has received FDA approval for its sodium oxybate oral solution 500 mg/mL, expanding its Affordable Medicines portfolio and providing a more affordable alternative for narcolepsy treatment [1][3]. Company Overview - Amneal Pharmaceuticals, Inc. is a global biopharmaceutical company headquartered in Bridgewater, NJ, with a diverse portfolio of over 280 pharmaceuticals, primarily in the U.S. [4]. - The company operates in various segments, including Affordable Medicines, Specialty, and AvKARE, focusing on complex product categories and therapeutic areas [4]. Product Details - Sodium oxybate is a central nervous system depressant used to treat cataplexy and excessive daytime sleepiness in patients aged 7 and older with narcolepsy [2]. - The approval of sodium oxybate oral solution addresses a critical therapy area for approximately 150,000 individuals in the U.S. living with narcolepsy [3]. Market Impact - The introduction of sodium oxybate by Amneal is significant as it provides patients, providers, and payers with a more affordable option in a market historically dominated by a single manufacturer [3].

Amneal Pharmaceuticals (AMRX) 2025 Conference Summary Company Overview - Amneal Pharmaceuticals was founded in 2002 and became the fifth largest generics company in the United States by 2018, achieving sales of $1.2 billion [3][4] - The company has expanded its manufacturing capabilities in the U.S. and India, producing a wide range of products including oral solids, injectables, and specialty drugs [4] Key Business Segments - **Specialty Products**: The company acquired a specialty segment through the acquisition of Impax in 2018, focusing on complex generics and specialty drugs [5] - **Krexone**: Recently launched as a leading therapy for Parkinson's patients, with expectations of peak sales between $300 million to $500 million [6][7] - **Healthcare Distribution**: The acquisition of AvKARE in 2020 has led to double-digit growth in this segment, contributing significantly to overall sales [9] Market Dynamics - **Biosimilars**: The biosimilar market is expected to grow significantly, with potential savings of $100 billion annually if developed properly. Current development costs range from $70 million to $120 million, which could be reduced to $40 million to $60 million if phase three requirements are eliminated [11][12] - **Competition**: The competition in the biosimilars market has decreased due to high investment requirements, positioning Amneal favorably for future growth [13] Financial Performance - Revenue increased from $1.6 billion to $3.1 billion over the past five years, with profits rising to approximately $675 million [20] - The company aims to reduce leverage from 3.9 times to below three times, while generating strong cash flow [20][52] Product Pipeline and Innovations - Amneal is focusing on complex products, with 96% of its pipeline consisting of such items, moving away from commodity generics [43] - The company is also developing a new auto-injector for treating cluster headaches, expected to launch in September [39] Strategic Partnerships - Collaboration with Matsera for GLP-1 products, targeting emerging markets with a significant patient base [15][42] - The partnership aims to leverage Amneal's manufacturing capabilities and market access in various regions [40] Future Outlook - Amneal is committed to long-term growth in the biosimilars and specialty markets, with expectations of significant revenue increases in the coming years [19][46] - The company is positioned to capitalize on the growing demand for affordable medicines, including biosimilars and complex generics [25] Regulatory Environment - The company is actively engaging with government entities to address concerns about antibiotic production and supply chain vulnerabilities [31][33] Conclusion - Amneal Pharmaceuticals is on a growth trajectory, focusing on specialty products, biosimilars, and innovative drug delivery systems, while maintaining a strong financial position and strategic partnerships to enhance market presence [19][50]