FDA Grants Approval for Amneal Pharma's Generic Version of RESTASIS for Treating Dry Eye Disease
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
0mins
Should l Buy AMRX?
Source: NASDAQ.COM
FDA Approval: Amneal Pharmaceuticals has received FDA approval for its cyclosporine ophthalmic emulsion 0.05%, a generic version of AbbVie's RESTASIS, aimed at treating dry eye disease.
Product Details: The product is a sterile formulation in single-use vials designed to increase tear production in patients with dry eye syndrome due to ocular inflammation.
Market Impact: The U.S. annual sales for this medication were approximately $2.0 billion for the year ending September 2025, highlighting its significant market potential.
Launch Timeline: Amneal plans to launch the product in the first quarter of 2026, addressing a condition that affects an estimated 16.4 million adults in the U.S.
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Analyst Views on AMRX
Wall Street analysts forecast AMRX stock price to fall
3 Analyst Rating
3 Buy
0 Hold
0 Sell
Strong Buy
Current: 14.630
Low
13.00
Averages
14.33
High
15.00
Current: 14.630
Low
13.00
Averages
14.33
High
15.00
About AMRX
Amneal Pharmaceuticals, Inc. is a global pharmaceutical company, which develops, manufactures, markets and distributes a portfolio of essential medicines. Its Affordable Medicines segment includes a portfolio of over 280 product families covering a range of dosage forms and delivery systems, including both immediate and extended-release oral solids, powders, liquids, sterile injectables, nasal sprays, inhalation and respiratory products, biosimilar products, ophthalmic, films, transdermal patches and topicals. Its Specialty segment is engaged in the development, promotion, sale and distribution of branded pharmaceutical products, with a focus on products addressing central nervous system disorders, including Parkinson’s disease and endocrine disorders. Its AvKARE segment provides pharmaceuticals, medical and surgical products and services primarily to governmental agencies, predominantly focused on the U.S. Department of Defense and the U.S. Department of Veterans Affairs.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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See More
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