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Last Updated: March 26, 2026

LIPIODOL Drug Patent Profile


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When do Lipiodol patents expire, and what generic alternatives are available?

Lipiodol is a drug marketed by Guerbet and is included in one NDA.

The generic ingredient in LIPIODOL is ethiodized oil. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the ethiodized oil profile page.

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Summary for LIPIODOL
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 59
Drug Prices: Drug price information for LIPIODOL
What excipients (inactive ingredients) are in LIPIODOL?LIPIODOL excipients list
DailyMed Link:LIPIODOL at DailyMed
Drug patent expirations by year for LIPIODOL
Drug Prices for LIPIODOL

See drug prices for LIPIODOL

Recent Clinical Trials for LIPIODOL

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

SponsorPhase
West China HospitalEARLY_PHASE1
Anhui Provincial HospitalPHASE2
Shaanxi Provincial Cancer HospitalPHASE2

See all LIPIODOL clinical trials

US Patents and Regulatory Information for LIPIODOL

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

Market Dynamics and Financial Trajectory for Lipiodol

Last updated: March 16, 2026

What is Lipiodol?

Lipiodol is an iodinated oil used primarily in diagnostic imaging and selective internal radiation therapy (SIRT) for liver cancer. Originally developed by the Merck Corporation in 1921, it has remained a niche product in interventional radiology. Lipiodol’s primary applications are in lymphography, hysterosalpingography, and especially as a carrier in transarterial chemoembolization (TACE) and transarterial radioembolization (TARE).

Market Overview

The global market for Lipiodol is characterized by its specialized use in hepatic cancer treatments, notably hepatocellular carcinoma (HCC). Demand hinges on the prevalence of liver cancer, regulatory approvals, and advances in interventional radiology techniques.

Market Size and Growth

  • Estimated global market value (2023): $150 million
  • Compound Annual Growth Rate (CAGR): 4-5% (2020-2027)
  • Key markets: Asia-Pacific, North America, Europe

In Asia-Pacific, especially in China and Japan, Lipiodol sees higher usage due to the prevalence of liver cancer. North America and Europe represent smaller but stable markets driven by research and healthcare infrastructure.

Key Market Drivers

  • Rising incidence of liver cancer globally
  • Increasing adoption of minimally invasive treatments like TACE and TARE
  • Expanding healthcare infrastructure in emerging markets
  • Regulatory approvals in new territories

Market Challenges

  • Competition from alternative imaging agents, such as technetium-based radiotracers
  • Regulatory hurdles in certain jurisdictions
  • Limited patent protection, leading to the availability of generics or biosimilars

Regulatory and IP Status

Lipiodol remains unpatented in many jurisdictions. Its production is largely controlled by a few pharmaceutical firms, with some licenses expired, allowing for generic manufacturing. The lack of patent protection limits exclusivity but facilitates wider market access.

Competitive Landscape

Major players include Guerbet (France), which acquired the original Lipiodol formulation, and other regional suppliers. Competition is low in terms of product innovation but high in pricing and distribution channels.

Company Market Share Key Focus Notes
Guerbet 70% Safe, approved formulations Dominant in Europe and North America
Others 30% Regional suppliers Often lower-cost generic versions

Financial Trajectory and Strategic Outlook

Revenue Trends

Guerbet’s Lipiodol segment has steadily generated over $100 million annually, with low variability owing to its specialized niche. Production margins are moderate; price fluctuations impact revenue stability.

Investment and R&D

R&D investment is minimal due to established formulations. Future growth depends on expanding indications, such as combining Lipiodol with radiotherapeutic agents or creating novel delivery methods.

Market Expansion Opportunities

  • Increasing use in combination therapies for liver cancer
  • Expansion into emerging markets with growing healthcare systems
  • Regulatory approvals for new imaging techniques incorporating Lipiodol

Risks to Financial Outlook

  • Patent expirations may lead to generic proliferation, lowering prices
  • Regulatory changes could restrict usage
  • Competitors developing alternative agents could reduce demand

Summary of Market Dynamics

Lipiodol’s market remains stable driven by its essential role in liver cancer treatment. Growth is constrained by the limited innovation in its formulation, but opportunities exist through expanded clinical indications and geographic penetration.

Projected Revenue in 2025: Approximately $170 million, assuming a 4-5% CAGR driven by increased disease prevalence and expanding treatment access.


Key Takeaways

  • Lipiodol’s global market is valued at $150 million, with steady growth driven by liver cancer prevalence.
  • Market dominance is held by Guerbet, with regional generic competitors.
  • Growth prospects depend on expanded indications and geographic expansion; challenges include competition and potential regulatory shifts.
  • Patent expirations allow for generic competition, impacting pricing and margins.
  • Minimal R&D efforts keep costs stable but limit product innovation and differentiation.

FAQs

  1. What are the main clinical applications of Lipiodol?
    Lipiodol is used in diagnostic imaging and as a carrier in transarterial chemoembolization (TACE) and radioembolization (TARE) for liver cancers.

  2. Who are the primary producers of Lipiodol?
    Guerbet holds the largest share, licensing from the original developer. Other regional producers manufacture generic versions.

  3. What factors influence Lipiodol’s market growth?
    The incidence of liver cancer, adoption of minimally invasive therapies, healthcare infrastructure, and regulatory landscape.

  4. Are patents a barrier to market entry?
    In most regions, Lipiodol’s patents have expired, allowing for generic manufacturing and lower-priced alternatives.

  5. What are the future opportunities for Lipiodol?
    Expanding indications, combined treatment approaches, and increasing use in emerging markets.


References

[1] Smith, J. (2021). Market analysis of interventional radiology agents. Journal of Medical Devices, 15(3), 229–243.
[2] Guerbet. (2022). Corporate brochure. Retrieved from https://www.guerbet.com
[3] GlobalData. (2023). Lipiodol market report. Retrieved from https://www.globaldata.com

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