Amneal expands iohexol portfolio with FDA approval of new strengths
Amneal Pharmaceuticals, Inc. secured FDA approval for iohexol injection 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, and 300 mg iodine/mL in 50 mL vials. The company plans to launch these products in Q3FY26 to address the majority of U.S. market demand, supported by IQVIA data showing annual sales of approximately $706 million for the 12 months ended May 2026.
*this image is generated using AI for illustrative purposes only.
Amneal Pharmaceuticals, Inc. has received U.S. Food and Drug Administration (FDA) approval for additional strengths and vial presentations of iohexol injection, significantly expanding its injectable contrast portfolio. The approval includes 350 mg iodine/mL in 50 mL, 75 mL, and 100 mL vials, as well as 300 mg iodine/mL in 50 mL vials. Amneal plans to launch these products in the third quarter of 2026, positioning the portfolio to address the majority of U.S. market demand for iohexol injection.
Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients two weeks of age and older. The newly approved presentations complement Amneal’s previously approved and launched iohexol injection 300 mg iodine/mL in 100 mL vials. These approvals represent the first generic versions referencing OMNIPAQUE™ across the approved presentations.
Market Impact
With approvals spanning multiple strengths and vial presentations, Amneal expects its iohexol portfolio to address the majority of U.S. market demand for iohexol injection. This provides hospitals, imaging centers, and healthcare providers with greater flexibility and supply optionality.
Financial Context
According to IQVIA®, U.S. annual sales for iohexol injection for the 12 months ended May 2026 were approximately $706 million. This market size underscores the significance of Amneal’s expanded portfolio in the complex injectables and hospital products segment.
| Strength (mg iodine/mL) | Vial Sizes (mL) |
|---|---|
| 350 | 50, 75, 100 |
| 300 | 50 |
How will Amneal's entry into the $706 million iohexol market impact the pricing strategies of established branded competitors like OMNIPAQUE™?
What potential legal challenges or patent disputes might arise regarding the first-to-file generic status across these new presentations?
Could the expanded portfolio drive Amneal to pursue acquisitions or partnerships to further strengthen its hospital supply chain capabilities?
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