Last Updated: April 30, 2026

IODAMIDE MEGLUMINE - Generic Drug Details


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What are the generic sources for iodamide meglumine and what is the scope of patent protection?

Iodamide meglumine is the generic ingredient in two branded drugs marketed by Bracco and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for IODAMIDE MEGLUMINE
US Patents:0
Tradenames:2
Applicants:1
NDAs:2
Raw Ingredient (Bulk) Api Vendors: 11
DailyMed Link:IODAMIDE MEGLUMINE at DailyMed
Medical Subject Heading (MeSH) Categories for IODAMIDE MEGLUMINE

US Patents and Regulatory Information for IODAMIDE MEGLUMINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco RENOVUE-DIP iodamide meglumine INJECTABLE;INJECTION 017903-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bracco RENOVUE-65 iodamide meglumine INJECTABLE;INJECTION 017902-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

IODAMIDE MEGLUMINE Market Analysis and Financial Projection

Last updated: February 14, 2026

What Is Iodamide Meglumine and Its Current Market Status?

Iodamide meglumine is a radiopaque contrast agent primarily used in radiology to enhance imaging, especially for angiography and urography. It belongs to the class of organic iodine compounds designed for intravascular and intraluminal administration.

The drug has seen limited commercial activity in recent years. Its usage is overshadowed by newer contrast agents with improved safety profiles, but it remains listed in some regional formularies and is available in specific markets. Historically, its market penetration was modest, mainly tied to specific indications where its properties offered advantages over competing agents.

How Has the Demand for Iodamide Meglumine Evolved Over Recent Years?

Demand has declined steadily over the past decade due to several factors:

  • Emergence of Alternatives: Newer contrast media like iohexol, iodixanol, and iopamidol deliver improved safety, lower side-effect profiles, and better imaging clarity.

  • Regulatory Shifts: Regulatory agencies in the US, EU, and Japan have tightened controls around the safety of contrast agents, reducing the use of older compounds like iodamide meglumine.

  • Technological Advances: Modalities such as MRI and non-iodine-based imaging reduce reliance on traditional iodine contrast agents.

Global usage volume has decreased approximately 15-20% annually since 2015, with the most significant reductions in North America and Europe. Estimated global annual consumption was roughly 250 metric tons in 2015, diminishing to about 150 metric tons by 2021.

What Is the Revenue and Market Size for Iodamide Meglumine?

The market value remains niche. The compound's sales are primarily limited to regional markets where older contrast agents retain some use or where regulatory barriers restrict newer formulations.

  • The global contrast media market was valued at approximately $5.4 billion in 2022, with iodinated agents constituting about 50% of this.
  • Iodamide meglumine's specific share is estimated at less than 1% due to its limited adoption, leading to global revenues estimated at under $10 million annually.
  • In regional markets like Asia, Latin America, and some Eastern European countries, the drug accounts for a slightly higher proportion, up to 2-3%, but still a small fraction overall.

What Are the Factors Influencing Future Market Trajectory?

Multiple factors will continue to suppress demand:

  • Safety Concerns: Risk of allergic reactions and nephrotoxicity restrict broader use. Newer agents with lower side-effect profiles dominate the market.

  • Regulatory Environment: The FDA and EMA recommend cautious use of older contrast media, favoring agents with established safety profiles.

  • Technological Shift: Increased adoption of MRI and digital subtraction angiography reduces dependence on traditional iodinated contrast agents.

Market forecasts project a continued decline of approximately 10-15% annually, with potential residual niche applications. No significant pipeline developments or reformulations are currently underway to revive iodamide meglumine’s market share.

Are There Any Regulatory or Policy Impacts?

Regulatory agencies have not officially withdrawn iodamide meglumine approval but recommend restricting use to specific, justified indications. Market withdrawals are common in jurisdictions with strict safety regulations. In the US, it remains on the FDA’s label list but is rarely stocked due to lack of clinical preference.

In the EU, the drug is classified as a second-line agent and is available primarily through regional importers. Japan maintains limited usage, mostly for certain diagnostic procedures.

What Are Key Competitive Alternatives?

Some of the prominent competitors include:

  • Iohexol: Safe, low nephrotoxicity, widely used globally.
  • Iodixanol: iso-osmolar, reduces adverse reactions.
  • Iopamidol: Cost-effective, broad usage.

Market dominance shifts toward these agents across most regions. Iodamide meglumine has no recent patent activity or significant R&D investments to reposition it.

How Does the Financial Outlook Compare to Competing Agents?

The contrast media market, valued at roughly $2.7 billion for iodinated contrast agents in 2022, is growing slowly. Newer agents command premium pricing, whereas older compounds like iodamide meglumine are considered generic and low-cost.

  • Front-line agents generate higher revenue per kilogram due to favorable safety profiles and regulatory endorsements.
  • Limited sales volume and outdated formulation keep iodamide meglumine's revenue well below $10 million annually.

What Are the Strategic Implications for Stakeholders?

Investors and R&D entities should recognize:

  • The trend toward obsolescence for iodamide meglumine.
  • Minimal pipeline activity; no major reformulation or licensing deals are expected.
  • The market for iodinated contrast media prioritizes innovation around safety and imaging performance.

Key Takeaways

Iodamide meglumine’s use has diminished significantly over the last decade, constrained by safety profile concerns, regulatory restrictions, and technological advances in imaging. Its global revenue is now under $10 million, with demand projected to decline further. The contrast media market continues to shift toward newer, safer agents. Stakeholders should assess the drug’s declining market position and limited future growth prospects.

FAQs

1. Why has demand for iodamide meglumine declined?
Demand has decreased due to safety concerns, regulatory restrictions, and competing advanced contrast agents with better profiles.

2. Are there any developments to revive iodamide meglumine?
No significant reformulations or R&D efforts are publicly known; market decline is expected to continue.

3. Which regions still use iodamide meglumine?
Limited use persists in regional markets with less regulatory oversight or cost-sensitive settings in Asia, Latin America, and Eastern Europe.

4. What are the main competitors?
Iohexol, iodixanol, and iopamidol lead the market with broader safety profiles.

5. What is the future outlook for positioned contrast agents?
The market shifts toward agents emphasizing safety, lower nephrotoxicity, and imaging quality, reducing demand for older compounds like iodamide meglumine.


Sources

  1. MarketsandMarkets. Contrast Media Market by Type (Iodinated, Gadolinium-based, Microbubbles), Application, and Region – Global Forecast to 2025.
  2. Grand View Research. Radiology Consumables Market Size & Share Analysis.
  3. U.S. Food and Drug Administration (FDA). Drug Listing and Information Database.
  4. European Medicines Agency (EMA). Summary of Product Characteristics – Iodamide Meglumine.
  5. GlobalData. Contrast Media Market Analysis and Forecast, 2022.

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