The Bull Case For Amneal Pharmaceuticals (AMRX) Could Change Following FDA Approval of First Generic Omnipaque

• Amneal Pharmaceuticals recently announced that the U.S. FDA has approved its generic iohexol injection (300 mg Iodine/mL), the first generic version of GE Healthcare’s Omnipaque, with plans to launch in the first quarter of 2026.
• This approval opens the door for Amneal to compete in a U.S. market for iohexol injections that saw approximately US$652 million in annual sales as of September 2025.
• We’ll explore how Amneal’s entry into the high-value generic contrast agent market could influence its broader growth outlook and competitive positioning.

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Amneal Pharmaceuticals Investment Narrative Recap

To be a shareholder in Amneal Pharmaceuticals, you need to believe that the company can capitalize on the growing demand for complex generics while effectively managing risks from pricing pressure and regulatory costs. The FDA approval and planned launch of generic iohexol injection could support near-term growth, yet intense competition and continued margin compression remain the most significant short-term risk and are unlikely to be materially altered by this single product entry.

Of recent announcements, the tentative approval of the beclometasone dipropionate HFA inhalation aerosol stands out as particularly relevant. As Amneal seeks to diversify with complex inhale and injectable products, these pipeline milestones provide further opportunities for top-line enhancement but will face existing pressures from the same generics market dynamics driving risk in the iohexol launch.

In contrast, margin compression from sustained price competition is something investors should be aware of as...

Read the full narrative on Amneal Pharmaceuticals (it's free!)

Amneal Pharmaceuticals is projected to reach $3.5 billion in revenue and $207.9 million in earnings by 2028. This outlook assumes a 7.2% annual revenue growth rate and an earnings increase of $204.5 million from current earnings of $3.4 million.

Uncover how Amneal Pharmaceuticals' forecasts yield a $13.50 fair value, a 13% upside to its current price.

Exploring Other Perspectives

Three Simply Wall St Community members estimate Amneal’s fair value between US$11.94 and US$69.18 per share. With price pressure in U.S. generics a persistent risk, explore these diverse viewpoints to broaden your understanding.

Explore 3 other fair value estimates on Amneal Pharmaceuticals - why the stock might be worth just $11.94!

Build Your Own Amneal Pharmaceuticals Narrative

Disagree with existing narratives? Create your own in under 3 minutes - extraordinary investment returns rarely come from following the herd.

• A great starting point for your Amneal Pharmaceuticals research is our analysis highlighting 4 key rewards and 4 important warning signs that could impact your investment decision.
• Our free Amneal Pharmaceuticals research report provides a comprehensive fundamental analysis summarized in a single visual - the Snowflake - making it easy to evaluate Amneal Pharmaceuticals' overall financial health at a glance.

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This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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