Amneal announced that the U.S. Food and Drug Administration approved its generic iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque contrast agent. The approval, granted on November 13, 2025, allows the company to begin commercial sales in the first quarter of 2026, positioning Amneal to capture a share of the U.S. contrast‑agent market, which is estimated to generate roughly $652 million in annual sales.
The entry into this high‑volume market aligns with Amneal’s strategic focus on complex injectables and differentiated therapeutic areas. By adding iohexol injection to its portfolio, the company diversifies beyond traditional generics, leverages its U.S. manufacturing footprint—including facilities in New Jersey and Kentucky—and strengthens its Affordable Medicines segment. The approval also supports Amneal’s broader transformation into a diversified biopharmaceutical company that balances specialty, affordable, and advanced‑therapy products.
Amneal’s recent financial performance underscores the significance of the new product launch. In Q3 2025, the company reported net revenue of $785 million, up 12% year‑over‑year, and adjusted diluted earnings per share of $0.17, a 6% increase from Q3 2024. Segment‑level growth was driven by 8% increases in both Specialty and Affordable Medicines and a 24% jump in AvKARE, reflecting strong demand across its product lines. The addition of iohexol injection is expected to further lift revenue and improve margins by adding a high‑margin, high‑volume injectable to the mix.
Management highlighted the strategic importance of the approval. Senior Vice President Arash Dabestani said, “We are very proud to introduce the first‑to‑market generic version of this critical and widely used injectable contrast agent for patients and healthcare providers.” Co‑Founder and Co‑CEO Chirag Patel added, “Amneal delivered another strong quarter and updated our 2025 outlook, underscoring the strength of our diversified business and the ongoing evolution of our portfolio.” The comments signal confidence that the new product will reinforce Amneal’s leadership in differentiated, complex injectables and support its long‑term growth trajectory.
The FDA approval is expected to enhance Amneal’s product mix, potentially improve operating margins, and provide a new revenue stream that complements its existing specialty and affordable medicines businesses. By entering a market with substantial annual sales, Amneal positions itself to capture market share from incumbent players, thereby strengthening its competitive stance and supporting its broader strategy of expanding into biosimilars, GLP‑1, and other advanced therapies.
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