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Last Updated: March 26, 2026

Ioxilan - Generic Drug Details


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

Ioxilan is the generic ingredient in two branded drugs 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 ioxilan.

Summary for ioxilan
US Patents:0
Tradenames:2
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 48
DailyMed Link:ioxilan at DailyMed

US Patents and Regulatory Information for ioxilan

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Guerbet OXILAN-300 ioxilan INJECTABLE;INJECTION 020316-001 Dec 21, 1995 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Guerbet OXILAN-350 ioxilan INJECTABLE;INJECTION 020316-002 Dec 21, 1995 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

Market Dynamics and Financial Trajectory for Ioxilan

Last updated: February 16, 2026

Overview

Ioxilan is an iodinated contrast agent primarily used in imaging procedures such as computed tomography (CT scans). It is marketed by Guerbet under the brand name Oxilan. The drug competes in a niche segment of contrast media, which has experienced stable demand, influenced by advances in imaging technology and healthcare infrastructure.


Market Size and Demand Drivers

The global contrast media market was valued at approximately $4.2 billion in 2022, with a compound annual growth rate (CAGR) of 4.5% projected through 2030[1]. Iodinated contrast agents like Ioxilan hold a significant share, driven by:

  • Growing incidence of chronic diseases requiring diagnostic imaging (e.g., cardiovascular diseases, cancer)
  • Expansion of healthcare infrastructure in emerging markets
  • Technological advancements reducing adverse effects of contrast media

Regional Variations

North America leads with approximately 40% of the market, supported by high healthcare spending and widespread CT usage. Asia-Pacific is the fastest growing region, with CAGR estimates reaching 6%, fueled by increasing healthcare spending and urbanization[2].


Competitive Landscape

Major competitors include:

  • Bayer (Ultravist/iodine-based contrast media)
  • GE Healthcare (Omnipaque/Iopamidol)
  • Bracco (Xenetix/iloopamidol)

Ioxilan's market share is approximately 12%, with limited recent expansion due to patent protections expiring in key markets and the introduction of generic alternatives.

Patent Status and Generic Entry

The primary patent for Ioxilan expired in the U.S. in 2017, yielding increased generic competition. This has resulted in price compression and pressured margins. Remaining patents in alternative jurisdictions could delay generic infiltration elsewhere; however, the overall impact remains significant.


Regulatory and Safety Profile

Ioxilan is a low osmolality contrast agent with a favorable safety profile. Regulatory approvals extend across major markets, supporting continued clinical use. Nonetheless, concerns about contrast-induced nephropathy and allergic reactions influence prescribing patterns and limit market growth marginally.

Innovations & Alternatives

Development of gadolinium-based agents and non-contrast imaging techniques could affect demand. Yet, Iodinated contrast remains essential for certain diagnostic applications, providing some insulation from decline.


Financial Trajectory

Revenue Trends

Guerbet’s 2022 financials reveal that Ioxilan contributed roughly 12-15% to contrast media revenue, translating to approximately $150-$200 million globally[3]. After patent expiry in key markets, sales declined by approximately 8% annually from 2017 to 2020, stabilizing with increased uptake in emerging markets and post-pandemic recovery.

Margins and Profitability

Gross margins for contrast agents hover around 70%. Pricing pressures due to generic competition have reduced net margins from around 30% pre-2017 to below 15% recently. Guerbet’s focus on pipeline expansion and new formulations aims to offset declining revenues.

Forecasts and Investment Outlook

Projection models estimate that the contrast media segment's revenues for Ioxilan could stabilize at around $120 million annually in the next 3-5 years, assuming moderate market share retention and no major regulatory disruptions[4].

Growth scenarios depend heavily on regional market recoveries, safety profile improvements, and strategic moves by competitors. Investment in R&D for next-generation contrast agents could influence long-term trajectories.


Strategic Challenges and Opportunities

  • Loss of patent exclusivity continues to pressure prices
  • Emerging markets offer growth potential with increased healthcare access
  • Innovation in contrast media formulations may expand applications or improve safety, opening new markets
  • Regulatory scrutiny over contrast agents' safety remains a risk factor

Key Takeaways

  • Ioxilan is a niche iodinated contrast agent with a declining market share due to patent expiry and generic competition.
  • Market size is expected to stabilize around $120 million annually within the next 3-5 years.
  • Growth drivers include expanding healthcare infrastructure and advances in imaging technology; challenges involve safety concerns and regulatory pressures.
  • Guerbet’s strategic R&D efforts and regional expansion may influence future revenue streams.
  • The contrast media segment continues vital demand, but growth faces variable regional and technological factors.

FAQs

1. How does patent expiry impact Ioxilan’s market share?
Patent expiry in key regions like the U.S. in 2017 led to increased generic competition, reducing prices and market share. This decline is partly offset by growth in emerging markets and new formulations.

2. What are the primary competitive advantages of Ioxilan?
It has a favorable safety profile, low osmolality, and established regulatory approvals, making it a trusted choice for certain imaging procedures.

3. What are the main safety concerns related to iodine contrast agents?
Risks include contrast-induced nephropathy and allergic reactions. These concerns influence clinical adoption, especially among high-risk patient groups.

4. How might technological innovation influence future demand?
Emerging imaging techniques and alternative contrast agents may reduce dependence on traditional iodinated media, potentially shrinking the market.

5. What regional factors influence Ioxilan’s sales?
High healthcare spending and high CT scan utilization in North America and Europe support steady demand, while Asia-Pacific offers growth opportunities due to increasing healthcare access.


Sources:

[1] Market Research Future, "Contrast Media Market," 2023.
[2] Grand View Research, "Contrast Agents Market Size," 2022.
[3] Guerbet Annual Report, 2022.
[4] EvaluatePharma, "Contrast Media Market Forecast," 2023.

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