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Last Updated: March 26, 2026

Ethiodized oil - Generic Drug Details


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What are the generic drug sources for ethiodized oil and what is the scope of patent protection?

Ethiodized oil is the generic ingredient in one branded drug marketed by Guerbet and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There is one drug master file entry for ethiodized oil. One supplier is listed for this compound.

Summary for ethiodized oil
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 8
What excipients (inactive ingredients) are in ethiodized oil?ethiodized oil excipients list
DailyMed Link:ethiodized oil at DailyMed
Recent Clinical Trials for ethiodized oil

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Assistance Publique - Hôpitaux de ParisPHASE3
Ministry of Health, FrancePHASE3
Ain Shams UniversityPhase 3

See all ethiodized oil clinical trials

Medical Subject Heading (MeSH) Categories for ethiodized oil
Anatomical Therapeutic Chemical (ATC) Classes for ethiodized oil

US Patents and Regulatory Information for ethiodized oil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Guerbet LIPIODOL ethiodized oil OIL;INTRALYMPHATIC, INTRAUTERINE 009190-001 Approved Prior to Jan 1, 1982 RX Yes Yes ⤷  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

Ethiodized oil Market Analysis and Financial Projection

Last updated: February 15, 2026

What Are the Market Dynamics for Ethiodized Oil?

Ethiodized oil is primarily used as a radiopaque contrast agent in lymphography, particularly for imaging lymphatic vessels and nodes. Its market depends on the broader diagnostic imaging and lymphatic mapping segments.

Key Drivers

  • Medical Imaging Adoption: The expansion of minimally invasive diagnostics increases demand. Lymphography usage, historically niche, is declining due to advances in MRI, PET, and CT imaging.
  • Oncology Applications: Used for preoperative lymphatic mapping in breast cancer, melanoma, and other tumors. The prevalence of such cancers influences demand.
  • Regional Usage Variations: High usage in developing countries due to cost-effective alternatives; lower in regions with advanced imaging modalities.

Market Constraints

  • Limited Clinical Indications: Narrow application scope restricts market growth.
  • Advancement of Alternatives: MRI and nuclear lymphoscintigraphy minimize reliance on radio-opaque agents.
  • Regulatory Challenges: Approval processes for new uses or formulations can delay market expansion.

Competitive Landscape

Few manufacturers produce Ethiodized oil, mainly international companies such as Guerbet and Bayer. Market entry barriers are high due to regulatory requirements and the specialized application.

Market Size and Growth

Analysts estimate the global radiopaque lymphography agent market was valued at approx. $50 million in 2022. CAGR is projected between 3-5% through 2027, driven by slow adoption of traditional lymphography methods and gradual acceptance of newer imaging technologies.

Regional Outlook

  • North America: Declining usage as MRI-PET imaging becomes prevalent.
  • Europe: Similar trends with some remaining applications in research.
  • Asia-Pacific: Increased use due to cost-effectiveness and growing healthcare infrastructure.

How Is the Financial Trajectory Shaping for Ethiodized Oil?

Financial prospects for Ethiodized oil are constrained.

Revenue Trends

  • The global market for Ethiodized oil saw stagnant revenues from 2018 to 2022, hovering around $30-50 million annually.
  • Growth in adjacent sectors, such as interventional radiology, does not significantly boost Ethiodized oil profitability owing to its specific application.

Manufacturing and Pricing

  • Production involves complex extraction and sterilization processes.
  • Average price per injection ranges between $20 and $50 depending on region and supplier.
  • Market reliance on a small number of suppliers limits pricing power.

R&D and Innovation

Research on new formulations or broader applications remains limited. Regulatory hurdles and low profitability reduce investment incentives.

Forecast

Projected revenues remain stable at best, with potential decline due to technological shifts. Investments in alternative diagnostic agents and imaging modalities further temper growth prospects.

How Do External Factors Influence Market and Financial Trends?

  • Regulatory Changes: Stricter regulations for radiopaque agents could restrict use or increase costs.
  • Healthcare Policy: Reimbursement cuts or shifts toward non-radiologic diagnostics reduce application volume.
  • Technological Advances: MRI-based lymphography and nuclear imaging supplant traditional agents.
  • Economic Conditions: Variations in healthcare spending impact procurement, especially in emerging markets.

Key Market Challenges and Opportunities

Challenges Opportunities
Narrow application scope Integration with newer imaging modalities in multi-modal diagnostics
Competition from advanced imaging Development of formulations with broader clinical utility
Regulatory hurdles Streamlining approval pathways for new indications

Final Outlook

Market remains steady but faces declining relevance owing to technological advances. Financially constrained by small, specialized demand without significant innovation or expansion.


Key Takeaways

  • Ethiodized oil’s use is confined to lymphography, mainly for oncological and diagnostic procedures.
  • Market size is approximately $50 million globally, with low growth prospects.
  • Advances in MRI and nuclear imaging are reducing demand.
  • Limited suppliers and rigid applications hinder substantial revenue increases.
  • External factors like regulation and healthcare policies affect its adoption trajectory.

FAQs

Q1: What are the primary applications of Ethiodized oil?
Lymphographic imaging in oncology, particularly for visualizing lymph nodes preoperatively.

Q2: Why is the Ethiodized oil market shrinking?
Emerging imaging technologies like MRI and PET reduce reliance on radiopaque agents in lymphography.

Q3: Who are the main manufacturers of Ethiodized oil?
Guerbet and Bayer are key players globally.

Q4: Can Ethiodized oil be used outside lymphography?
Potentially, but limited by regulatory approvals and clinical efficacy data.

Q5: What factors could revitalize demand for Ethiodized oil?
Development of new formulations for broader diagnostic uses, regulatory approvals for additional indications.


Sources:
[1] MarketWatch, "Radiopaque Lymphography Agents Market Size," 2023.
[2] GlobalData, "Medical Imaging Market Trends," 2022.
[3] Pharma Intelligence, "Oncology Imaging," 2021.

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