Core Insights - Amneal Pharmaceuticals has received FDA approval for its cyclosporine ophthalmic emulsion 0.05%, a sterile, preservative-free formulation in single-use vials, which is a generic equivalent of RESTASIS® [1][3] - The launch of this product is expected in Q1 2026, highlighting Amneal's capabilities in complex ophthalmic therapies and sterile manufacturing [1][2] Product and Market Impact - Cyclosporine ophthalmic emulsion 0.05% is indicated for increasing tear production in patients with dry eye syndrome, particularly those with ocular inflammation [2] - The annual sales for cyclosporine ophthalmic emulsion 0.05% in the U.S. were approximately $2.0 billion for the 12 months ending September 2025, indicating a significant market opportunity [3] Company Overview - Amneal Pharmaceuticals is a global biopharmaceutical company based in Bridgewater, NJ, with a diverse portfolio of over 290 pharmaceuticals, focusing on complex product categories and therapeutic areas [4] - The company is expanding its presence in the Affordable Medicines segment, which includes injectables and biosimilars, as well as a growing portfolio in the Specialty segment targeting central nervous system and endocrine disorders [4]