ETHIODIZED OIL - Generic Drug Details

What are the generic sources for ethiodized oil and what is the scope of freedom to operate?

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.

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

Sponsor	Phase
Assistance Publique - Hôpitaux de Paris	PHASE3
Ministry of Health, France	PHASE3
Ain Shams University	Phase 3

See all ETHIODIZED OIL clinical trials

Medical Subject Heading (MeSH) Categories for ETHIODIZED OIL

Antineoplastic Agents

Contrast Media

Anatomical Therapeutic Chemical (ATC) Classes for ETHIODIZED OIL

A06AG	Enemas
A06A	DRUGS FOR CONSTIPATION
A06	DRUGS FOR CONSTIPATION
A	Alimentary tract and metabolism

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

Ethiodized Oil Market Dynamics, Lipiodol Financial Trajectory, Patents, and Generic Entry Risk

Last updated: September 5, 2026

Ethiodized oil is a mature, niche radiopaque pharmaceutical dominated by Guerbet’s Lipiodol product. Its commercial value comes from specialized procedures rather than broad prescription volume, particularly transarterial chemoembolization for hepatocellular carcinoma, lymphangiography, and hysterosalpingography. The market has limited direct generic competition, no meaningful active composition-patent barrier, and high dependence on manufacturing continuity, regulatory maintenance, and specialist procedure volumes.

Public companies do not report Lipiodol revenue as a separate line item. Financial analysis therefore relies on Guerbet’s group results, product positioning, procedure demand, regulatory status, and supply conditions rather than audited product-level sales.

What is ethiodized oil used for?

Ethiodized oil is an iodinated, oil-based contrast medium. Lipiodol Ultra-Fluid is the principal branded product associated with the active ingredient.

Attribute	Market position
Active ingredient	Ethiodized oil
Principal brand	Lipiodol Ultra-Fluid
Main manufacturer	Guerbet
Drug class	Oil-based iodinated radiopaque agent
Core procedures	TACE, lymphangiography, hysterosalpingography
Primary commercial markets	Europe, Asia, Latin America, selected North American indications
U.S. regulatory position	FDA-approved for hysterosalpingography in adults; other uses may be off-label
Product maturity	Mature, established injectable
Direct substitution	Limited in TACE and lymphatic imaging
Core patent status	Original composition and use patents are historical and generally expired

In hepatocellular carcinoma, ethiodized oil can act as both a radiopaque marker and a carrier for chemotherapeutic agents during conventional TACE. It is also used in lymphangiography to identify lymphatic anatomy and leaks. In reproductive medicine, it is used for hysterosalpingography, where oil-based contrast has been associated with higher pregnancy rates than some water-soluble alternatives in selected patients and clinical settings (ASRM, 2021).

What drives demand for ethiodized oil?

Demand is procedure-driven rather than prescription-driven. The main growth factors are the number of interventional oncology procedures, availability of angiography suites, liver cancer incidence, and adoption of lymphatic imaging techniques.

Hepatocellular carcinoma and TACE

TACE remains an important locoregional treatment for unresectable or intermediate-stage liver cancer. Ethiodized oil is used in conventional TACE, while drug-eluting beads and other embolic technologies compete for the same clinical setting.

The product has a stronger position where physicians prefer conventional TACE, where local guidelines support lipiodol-based delivery, or where cost constraints favor established catheter-based procedures over newer drug-device systems. Demand is weaker in institutions that have shifted toward drug-eluting bead TACE, radioembolization, systemic immunotherapy, or combination treatment pathways.

The long-term market is therefore exposed to two opposing trends:

• Rising global liver cancer incidence supports procedure demand.
• Treatment migration toward systemic therapy and alternative embolization technologies limits volume growth.

Lymphangiography

Lymphangiography is a smaller but strategically important market. Ethiodized oil is used for diagnostic mapping and, in some cases, treatment of lymphatic leaks. The indication depends on specialist expertise and access to interventional radiology services. Because the market is small, supply interruptions can have a disproportionate clinical effect.

Hysterosalpingography

Hysterosalpingography is the clearest U.S. regulatory market for Lipiodol. The procedure evaluates fallopian tube patency in infertility workups. Oil-based contrast has clinical differentiation versus water-soluble agents, but utilization depends on fertility clinic protocols, physician preference, reimbursement, and concerns regarding iodine-related adverse events.

What is the FDA regulatory status of ethiodized oil?

The FDA approved Lipiodol for hysterosalpingography in adult women. The approved indication does not cover every international use of the product. U.S. use in TACE and lymphangiography may be based on clinical practice, institutional protocols, or off-label use depending on the procedure and jurisdiction (U.S. Food and Drug Administration, 2017).

The regulatory profile is commercially favorable because the product is established and the clinical procedures are well known. It is also restrictive because a new competitor must demonstrate pharmaceutical quality, sterility, manufacturing consistency, and an acceptable clinical and regulatory pathway for its proposed indications.

What is the Orange Book status of Lipiodol?

Lipiodol’s principal commercial protection does not appear to depend on an active composition patent. Ethiodized oil has been used clinically for decades, and the foundational composition and broad-use patents are outside their ordinary enforceable terms.

The key U.S. regulatory questions are therefore:

Issue	Assessment
Active composition patent	No meaningful broad composition barrier expected
Orange Book-listed patent protection	No widely recognized blocking patent estate comparable to newer specialty drugs
Regulatory exclusivity	Historical exclusivity periods have expired or are not the main current barrier
Formulation protection	Potentially relevant at the manufacturing and product-quality level
Method-of-use patents	Older broad uses are generally vulnerable due to age and prior art
Generic approval route	Potentially available, subject to product-specific FDA requirements
Practical entry barrier	Manufacturing, sterile supply, clinical familiarity, and market size

Orange Book status should be distinguished from practical market exclusivity. A product can have no strong patent barrier and still face little competition because the market is small, the manufacturing process is specialized, and expected sales may not justify development costs.

How many patents protect ethiodized oil?

No substantial active patent estate is required to explain Lipiodol’s current position. The commercial moat is based on product history, manufacturing know-how, regulatory files, physician familiarity, and supply-chain execution.

Potentially relevant IP categories include:

1. Manufacturing processes for iodination and purification.
2. Sterile injectable formulation parameters.
3. Container-closure systems.
4. Packaging and shelf-life controls.
5. Procedure-specific delivery techniques.
6. Combination use with chemotherapeutic or embolic agents.

These categories may create narrower protection or trade-secret value, but they do not create the same barrier as a new molecular entity patent. Process patents also provide limited protection against a competitor that develops a non-infringing manufacturing route.

When does ethiodized oil lose exclusivity?

Ethiodyzed oil has already lost conventional product exclusivity in the patent sense. The relevant commercial question is when a competitor can obtain approval and reliably supply an equivalent product.

A generic entrant would need to address:

• Pharmaceutical equivalence to the reference product.
• Sterility and particulate control.
• Iodine content and physicochemical specifications.
• Oil viscosity and radiopacity.
• Container compatibility.
• Stability and shelf life.
• Clinical labeling and indication strategy.
• Adequate commercial scale for a niche injectable.

The absence of a blocking patent does not guarantee rapid entry. Injectable contrast products have higher quality and manufacturing risks than many oral generics. A failed inspection, inconsistent iodine content, or supply interruption could materially affect a small entrant’s economics.

Which companies compete with Lipiodol?

Direct competition is limited. The broader competitive landscape includes both alternative ethiodized-oil products and procedure substitutes.

Competitor category	Examples	Competitive effect
Direct ethiodized-oil products	Regional or historical alternatives to Lipiodol	Potential price and supply competition
Water-soluble contrast media	Iohexol, iopamidol, iopromide and related agents	Compete in hysterosalpingography and diagnostic imaging
Drug-eluting beads	Microsphere-based chemoembolization systems	Replace conventional lipiodol-based TACE in some centers
Radioembolization	Y-90 microspheres	Competes for liver-directed oncology procedures
Bland embolization	Embolic particles without drug delivery	Alternative interventional treatment
Cross-sectional imaging	CT and MRI contrast agents	Substitute only for selected diagnostic applications

The most important competitive threat is not a conventional generic. It is procedure migration from conventional TACE to drug-eluting beads, radioembolization, or systemic therapy.

What formulations are protected by ethiodized-oil IP?

The commercial product is an injectable oil-based formulation. Its economic value depends on consistent physical properties rather than a complex patented delivery platform.

Relevant formulation characteristics include:

• Stable iodine concentration.
• Uniform radiopacity.
• Low particulate burden.
• Sterility.
• Controlled viscosity.
• Compatibility with injection and catheter procedures.
• Stability in its marketed container.
• Consistent performance when mixed with chemotherapeutic agents.

These attributes can be difficult to reproduce at commercial scale even when the formulation is not protected by a strong patent. Manufacturing specifications and quality-control methods may therefore function as practical barriers.

How strong is the patent estate for Lipiodol?

The patent estate is weak relative to newer branded pharmaceuticals but the product remains commercially defensible.

Factor	Strength
Composition patents	Low
Broad method-of-use patents	Low
Formulation patents	Low to moderate, depending on specific claims
Manufacturing know-how	Moderate to high
Regulatory history	High
Physician familiarity	High in established procedure markets
Direct generic threat	Moderate in theory, low to moderate in practice
Substitution risk from drug devices	Moderate to high
Supply-chain moat	Moderate

The product’s defensibility is operational rather than patent-led. Guerbet benefits from an established regulatory file, global distribution, clinical recognition, and a specialized manufacturing platform.

What is the financial trajectory for ethiodized oil?

Guerbet does not publicly disclose Lipiodol revenue as a standalone product line. Its financial reports generally present consolidated sales and broader business segments, which include contrast media and related imaging products. As a result, Lipiodol’s revenue trajectory cannot be isolated from public filings with the precision available for a separately reported blockbuster.

The likely financial profile is:

Period	Financial interpretation
Historical period	Mature product with established recurring demand
Pre-pandemic	Supported by elective imaging, fertility procedures, and interventional oncology
2020-2021	Exposed to postponed procedures and hospital-capacity constraints
Recovery period	Benefited from resumed elective and interventional procedures
Current phase	Stable niche revenue, with volume growth offset by procedure substitution and pricing pressure
Long-term outlook	Low-to-moderate growth, but vulnerable to technology migration and supply disruption

Lipiodol is unlikely to be a major growth engine for Guerbet compared with newer or larger contrast products. Its value is more consistent with a durable specialty product that contributes recurring revenue, supports customer relationships, and occupies a differentiated procedural niche.

What generic entry risks exist for ethiodized oil?

A generic launch is legally possible but commercially difficult.

Launch scenario 1: No near-term direct generic

This is the most likely base case when the market remains small and the incumbent maintains reliable supply. The absence of patent protection does not by itself create an attractive return on investment.

Launch scenario 2: Regional competitor

A manufacturer may enter one or more markets where Lipiodol pricing is high, supply is constrained, or local registration requirements are manageable. Regional entry would create price pressure without necessarily producing a global competitor.

Launch scenario 3: U.S. abbreviated or hybrid approval

A U.S. entrant could pursue an ANDA or another product-specific pathway, subject to FDA requirements. The commercial case would depend on demonstrating equivalence and securing reimbursement, hospital formulary adoption, and stable sterile manufacturing.

Launch scenario 4: Procedure-level displacement

Drug-eluting beads, radioembolization, and systemic treatment combinations could reduce demand without any generic launch. This is the most important medium- to long-term risk to the product franchise.

What patent litigation affects ethiodized oil?

There is no widely reported, market-defining patent litigation campaign comparable to disputes involving high-value small-molecule drugs or biologics. The low-value patent estate reduces the likelihood of prolonged Paragraph IV litigation.

Litigation risk is more likely to arise from:

• Product liability.
• Manufacturing defects.
• Sterility failures.
• Regulatory enforcement.
• Distribution or supply agreements.
• Trademark and brand disputes.
• Hospital procurement and reimbursement issues.

No major public settlement agreement is central to the current commercial profile of ethiodized oil.

What licensing deals affect Lipiodol?

The product’s market position is primarily associated with Guerbet’s own commercial and manufacturing platform. No major publicly disclosed licensing transaction appears to define the current Lipiodol market. Any regional distribution or commercialization arrangements are less important than Guerbet’s ownership, supply, and regulatory control of the established product.

What is the geographic coverage of ethiodized oil?

Ethiodized oil has broader international clinical use than its U.S. label alone suggests. Commercial demand is strongest where conventional TACE, lymphangiography, and oil-based hysterosalpingography remain established.

Geographic performance depends on:

• National approval status.
• Reimbursement.
• Hospital procurement.
• Interventional radiology capacity.
• Liver cancer incidence.
• Local treatment guidelines.
• Availability of competing embolization products.

Emerging markets can support volume growth, but price levels and tender-based procurement can limit revenue expansion. Developed markets generally provide stronger pricing but face greater adoption of competing technologies.

Key takeaways

• Ethiodized oil is a mature specialty pharmaceutical led by Guerbet’s Lipiodol.
• Its main uses are conventional TACE, lymphangiography, and hysterosalpingography.
• The product has little meaningful active composition-patent protection.
• Practical barriers include sterile manufacturing, regulatory history, supply reliability, and limited market size.
• Guerbet does not publicly report Lipiodol revenue separately.
• Revenue is likely stable and recurring rather than high-growth.
• The largest long-term threat is procedure substitution, particularly drug-eluting beads, radioembolization, and systemic liver-cancer therapy.
• A generic launch is legally possible but may be commercially unattractive without supply shortages or pricing dislocation.
• No major public Paragraph IV litigation or settlement currently defines the market.
• Financial exposure is meaningful as a durable niche product but limited relative to Guerbet’s overall contrast-media portfolio.

FAQs

Is ethiodized oil the same as Lipiodol?

Ethiodized oil is the active pharmaceutical ingredient. Lipiodol is Guerbet’s branded product containing ethiodized oil.

Is Lipiodol approved for TACE in the United States?

The U.S. label centers on hysterosalpingography. Use in TACE may be outside the approved U.S. indication, although it is an established international clinical application.

Can a generic company manufacture ethiodized oil?

Yes, in principle. A manufacturer would still need to meet FDA or other national requirements for equivalence, sterility, stability, manufacturing controls, and labeling.

Is ethiodized oil a biologic or biosimilar product?

No. Ethiodized oil is a small-molecule iodinated pharmaceutical and is not regulated through the biosimilar pathway.

What is the main investment risk for Lipiodol?

The main risk is procedural displacement rather than patent expiry. Hospitals may shift from conventional lipiodol-based TACE to drug-eluting beads, radioembolization, or systemic therapies.

References

1. American Society for Reproductive Medicine. (2021). Role of tubal surgery in the era of assisted reproductive technology: A committee opinion. Fertility and Sterility, 115(5), 1143-1150.

2. Guerbet. (2023). Universal registration document and annual financial report 2023. Guerbet S.A.

3. U.S. Food and Drug Administration. (2017). Lipiodol Ultra-Fluid prescribing information. U.S. Department of Health and Human Services.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations: The Orange Book. U.S. Department of Health and Human Services.

5. European Association for the Study of the Liver. (2023). EASL clinical practice guidelines on the management of hepatocellular carcinoma. Journal of Hepatology, 79(5), 1261-1317.