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Last Updated: December 17, 2025

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: 58
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
The Second Affiliated Hospital of Harbin Medical UniversityPHASE2
Henan Provincial People's HospitalPHASE2
Anhui Provincial 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 ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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: July 30, 2025

Introduction

Lipiodol, an iodinated oil-based contrast agent and therapeutic agent, has carved a niche within diagnostic and interventional radiology, especially in hepatocellular carcinoma (HCC) treatment. Initially developed as a diagnostic tool, Lipiodol’s unique properties have propelled its transformation into a therapeutic adjunct, influencing market dynamics and financial prospects. This analysis provides an in-depth examination of Lipiodol’s market landscape, growth drivers, competitive aspects, regulatory trends, and forecasting the financial trajectory in the coming decade.

Historical Background and Product Profile

Lipiodol, trade-named after its discoverer, Sophie Lipiodol in 1921, was first used as a lymphographic contrast agent. Its lipid-based structure allows selective accumulation within hypervascular tumors, notably HCC, enabling both diagnostic imaging and localized chemotherapeutic delivery. Currently, Lipiodol’s primary applications encompass:

  • Diagnostic Imaging: Hepatic arteriography and lymphography.
  • Therapeutic Use: Transarterial chemoembolization (TACE) for liver cancer management.

Manufactured mainly by Guerbet, Lipiodol’s legacy spans nearly a century, strengthening its reputation in specialized medical procedures.

Market Dynamics

1. Evolving Clinical Applications

Lipiodol’s dual functionality has sustained demand amid shifts in hepatic cancer management. The shift toward minimally invasive therapies—particularly TACE—has cemented Lipiodol’s role. Its ability to act as a contrast agent and carrier for chemotherapeutics enhances procedural efficacy, positioning it as an indispensable tool in interventional oncology.

2. Growing Burden of Liver Cancers

Globally, liver cancer ranks among top causes of cancer mortality, predominantly driven by hepatitis infections and cirrhosis. The International Agency for Research on Cancer (IARC) reports annual incidence surpassing 900,000 cases worldwide [1]. This surge fuels demand for effective localized treatments like Lipiodol-based TACE, fostering a robust market pipeline.

3. Regional Market Drivers

  • Asia-Pacific: Dominates the market due to high HCC prevalence — China, Japan, and South Korea lead major adoption.
  • North America and Europe: Increasing acceptance of minimally invasive interventions sustains steady demand, complemented by advanced healthcare infrastructure and regulatory approval for specific indications.

4. Competitive Landscape and Innovation

Guerbet remains the dominant manufacturer, benefiting from longstanding product trust. However, emerging competitors focus on developing newer embolic and imaging agents with improved safety profiles and efficacy, potentially displacing Lipiodol in certain indications [2].

Advancements like drug-eluting beads and targeted nano-embolic agents pose a competitive threat but also open avenues for combination therapies involving Lipiodol.

5. Regulatory and Policy Environment

FDA and EMA approvals influence market accessibility in North America and Europe. Recent regulatory clarity on Lipiodol’s use in specific interventional procedures sustains its market presence. Conversely, stricter regulatory scrutiny on iodinated agents emphasizes safety and necessitates ongoing compliance investments.

6. Supply Chain and Manufacturing Factors

Manufacturing Lipiodol involves sourcing high-purity iodine and lipids. Supply disruptions, regulatory compliance, and costs influence pricing strategies and profit margins, especially in emerging markets.

Financial Trajectory and Market Forecast

1. Market Size and Growth Projections

Recent market estimates place Lipiodol’s global market value at around $150 million (as of 2022), with a compound annual growth rate (CAGR) of approximately 4-5% projected over the next five years [3].

Factors supporting this growth include:

  • Rising incidence of HCC.
  • Increasing adoption of TACE and other minimally invasive therapies.
  • Expanding healthcare infrastructure in emerging markets.
  • Continued regulatory approvals expanding indications.

2. Revenue Drivers

Key contributors to revenue include:

  • Procedural Demand: More TACE procedures lead to higher Lipiodol utilization.
  • Regional Expansion: Growth in Asia-Pacific significantly impacts overall sales.
  • Product Pipeline: Partnerships or new formulations enhancing safety/effectiveness could broaden indications.

3. Market Challenges

  • Emerging Therapies: Anti-angiogenic drugs, immunotherapies, and targeted molecules present competition.
  • Regulatory Uncertainties: Changes in approvals or safety guidelines can impact volume and pricing.
  • Pricing Pressures: Healthcare cost containment policies may hinder revenue growth.

4. Strategic Outlook

Pharmaceutical companies are expected to prioritize:

  • Innovation: Developing combination formulations and enhanced imaging agents.
  • Geographical Expansion: Tapping into underserved markets with high HCC burden.
  • Collaborations: Partnering with healthcare providers to incorporate Lipiodol into integrated treatment protocols.

Regulatory and Market Trends Impacting Financials

  • Globalization of Healthcare Laws: Stricter compliance demands increase costs but ensure product safety.
  • Quality Standards: Enhanced sterility and bioavailability standards influence production costs.
  • Digital and Imaging Advances: Incorporation of Lipiodol into multimodal imaging strategies enhances procedural outcomes, potentially increasing demand.

Conclusion

Lipiodol’s market remains resilient, bolstered by its entrenched role in hepatic oncology and diagnostic applications. The rising prevalence of liver cancers, particularly in Asia-Pacific, coupled with the shift toward minimally invasive treatments, bolsters its growth prospects. Nonetheless, competition from newer embolization agents and evolving regulatory landscapes necessitate ongoing innovation and strategic adaptations.

Forecasts suggest a steady CAGR of around 4-5% over the next five years, with emerging markets and procedural innovation serving as critical growth pillars. Companies investing in product development, regional expansion, and regulatory alignments can capitalize on Lipiodol’s enduring clinical utility and market relevance.


Key Takeaways

  • Stable Market with Growth Potential: Despite competition, Lipiodol’s niche in interventional radiology ensures continued demand, especially in high-incidence regions.
  • Regional Disparities: Asia-Pacific remains the dominant market, driven by disease prevalence, while advanced economies present stable, mature markets.
  • Innovation as a Differentiator: Developing combination therapies and enhancing safety profiles are essential for maintaining market share.
  • Regulatory Influence: Policy changes and safety standards significantly impact both revenue and market access strategies.
  • Strategic Focus Areas: Companies should prioritize regional expansion, product innovation, and integration into minimally invasive treatment protocols to maximize financial returns.

FAQs

Q1: What are the main therapeutic applications of Lipiodol today?
Lipiodol is primarily used in transarterial chemoembolization (TACE) for hepatocellular carcinoma and as an imaging contrast agent in lymphography and hepatic arteriography.

Q2: How does Lipiodol’s market outlook compare with newer embolic agents?
While newer agents like drug-eluting beads offer improved therapeutic profiles, Lipiodol’s entrenched role and diagnostic capabilities sustain its demand. However, competition is likely to intensify, emphasizing the need for innovation.

Q3: What regions present the highest growth potential for Lipiodol?
Asia-Pacific dominates due to high liver cancer incidence, with China, Japan, and South Korea leading. Emerging markets in Latin America and Africa also offer opportunities through healthcare infrastructure development.

Q4: What challenges could impact Lipiodol’s market growth?
Regulatory restrictions, safety concerns, competition from advanced therapies, and pricing pressures could slow growth. Supply chain disruptions and costs also pose risks.

Q5: How can manufacturers enhance Lipiodol’s market competitiveness?
Focusing on safety improvements, demonstrating superior imaging and therapeutic efficacy, expanding indications, and forging strategic partnerships are vital strategies.


References

[1] International Agency for Research on Cancer. Global Cancer Statistics. 2022.

[2] MarketWatch. "Lipiodol Market Size & Forecast," 2023.

[3] Grand View Research. "Medical Imaging Contrast Agents Market," 2022.

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