Launch in Q3 2026 will begin contributing to Amneal's injectable revenue. Monitor market share capture against the brand (OMNIPAQUE) and other generics, as well as pricing dynamics. The approval is a steady positive but not a game-changer; expect modest upside from broader portfolio adoption.
Price Chart
Executive Summary
Amneal received FDA approval for additional strengths and vial presentations of iohexol injection, a generic version of OMNIPAQUE, expanding its injectable contrast portfolio. The $706 million U.S. market (IQVIA trailing 12 months) presents a significant revenue opportunity, with launch planned for Q3 2026. The approval is incrementally positive, broadening Amneal's hospital product offerings without being transformative.
Key Facts
- FDA approved iohexol injection 350 mg iodine/mL in 50 mL, 75 mL, 100 mL vials and 300 mg iodine/mL in 50 mL vial.
- These are the first generic versions of OMNIPAQUE across the approved presentations.
- Amneal plans to launch the products in Q3 2026.
- Annual U.S. sales of iohexol injection were approximately $706 million (IQVIA, 12 months ended May 2026).
- The approvals complement Amneal's previously approved iohexol 300 mg iodine/mL in 100 mL vial.
Financial Impact
Expands addressable market for iohexol injection, which has annual U.S. sales of ~$706 million; exact revenue contribution depends on market share and pricing.
Risk Factors
- Competition from other generic manufacturers and the branded product (GE HealthCare's OMNIPAQUE).
- Potential pricing pressure in the contrast agent market.
- Manufacturing or supply chain disruptions impacting launch timing.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3329047 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 23, 2026 3d ago | 8-K/A | $20.38 | awaiting T+60 | — | $21.29 (+4.47%) |
Sep 18, 2026 5w ago | Press Release | $20.16 | awaiting T+60 | — | $21.29 (+5.61%) |
Aug 16, 2026 10w ago | Institutional Cluster | $18.42 | awaiting T+60 | — | $21.29 (+15.58%) |
Aug 14, 2026 10w ago | Insider Cluster | $18.42 | awaiting T+60 | — | $21.29 (+15.58%) |
Aug 13, 2026 10w ago | Insider Cluster | $18.15 | awaiting T+60 | — | $21.29 (−17.30%) |
Aug 10, 2026 11w ago | 8-K | $17.10 | awaiting T+60 | — | $21.29 (+24.50%) |
Jul 30, 2026 12w ago | DEFA14A | $18.50 $20.38 | ▲ +10.16% | ▲ +7.70% | $21.29 (+15.08%) |
Jul 17, 2026 14w ago | Press Release | $17.85 $20.03 | ▲ +12.21% | ▲ +7.53% | $21.29 (+19.27%) |
Jun 29, 2026 17w ago | DEFM14A | $17.29 $19.50 | ▲ +12.78% | ▲ +8.40% | $21.29 (+23.13%) |
Jun 29, 2026 17w ago | Press Release | $17.29 $19.50 | ▲ +12.78% | ▲ +8.40% | $21.29 (+23.13%) |
US Market Status
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