metrizamide - Profile

What are the generic drug sources for metrizamide and what is the scope of freedom to operate?

Metrizamide is the generic ingredient in one branded drug marketed by Ge Healthcare and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for metrizamide

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for metrizamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-003	Sep 12, 1983		DISCN	No	No
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-002	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for metrizamide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-001	Approved Prior to Jan 1, 1982
Ge Healthcare	AMIPAQUE	metrizamide	INJECTABLE;INJECTION	017982-002	Approved Prior to Jan 1, 1982

Metrizamide: Patent Landscape and Investment Fundamentals

Last updated: February 19, 2026

Metrizamide, a non-ionic, water-soluble X-ray contrast agent, presents a complex investment scenario driven by its established market presence, ongoing patent challenges, and evolving diagnostic imaging technologies. Its primary use in contrast-enhanced computed tomography (CT) and angiography positions it within a critical segment of diagnostic medicine. Understanding the patent expiration timeline, competitive landscape, and regulatory environment is crucial for assessing investment viability.

What is Metrizamide and Its Therapeutic Applications?

Metrizamide is a triiodinated benzenoid compound utilized as an iodinated contrast medium. Its chemical structure allows for high radiodensity, facilitating the visualization of anatomical structures and pathologies in medical imaging.

• Primary Application: Contrast enhancement in Computed Tomography (CT) scans. This includes abdominal, pelvic, thoracic, and cranial imaging.
• Secondary Applications: Arthrography, myelography, and urography. These applications are less common with the advent of newer, more specialized contrast agents.

The efficacy of metrizamide relies on its ability to absorb X-rays, thereby increasing the contrast between tissues with similar X-ray attenuation properties. Its water solubility and low osmolality compared to older ionic agents contributed to improved patient tolerance and a reduced incidence of adverse reactions upon its introduction.

What is the Patent Status of Metrizamide?

The intellectual property surrounding metrizamide is largely expired, significantly impacting its market exclusivity. The original patents protecting its composition of matter and methods of use have lapsed in major markets.

• Original Composition of Matter Patents: Expired in the late 1990s.
• Method of Use Patents: Primarily related to specific imaging protocols and applications; these have also expired.

The lack of broad patent protection means that metrizamide is now a generic pharmaceutical product. This allows multiple manufacturers to produce and market the compound, leading to price competition. The absence of significant patent-driven market exclusivity limits the potential for premium pricing and necessitates a focus on manufacturing efficiency and market share acquisition for commercial success.

Who Are the Key Competitors in the Contrast Agent Market?

The contrast agent market is highly competitive, featuring a range of products with varying chemical compositions, properties, and indications. Metrizamide competes not only with other iodinated contrast agents but also with non-iodinated alternatives and newer generations of imaging technology that may reduce the need for contrast.

• Iodinated Non-Ionic Agents:
  • Iohexol (Omnipaque): A widely used agent with a broad range of applications. (2023 Global Sales: Approximately $1.8 billion) [1]
  • Iopamidol (Isovue): Another leading non-ionic agent, comparable in efficacy and safety profile to iohexol. (2023 Global Sales: Approximately $1.6 billion) [1]
  • Ioversol (Optiray): Known for its lower viscosity, facilitating easier administration. (2023 Global Sales: Approximately $950 million) [1]
• Iodinated Ionic Agents (Older generation, less common now):
  • Diatrizoate (Hypaque): One of the earliest ionic contrast agents.
  • Iothalamate (Conray): Another older ionic agent.
• Other Contrast Modalities:
  • Gadolinium-based agents: Used for Magnetic Resonance Imaging (MRI). While not direct competitors in X-ray imaging, they represent alternative diagnostic tools.
  • Ultrasound contrast agents: Microbubble-based agents used in ultrasound imaging.

The competitive pressure from established, well-patented agents like iohexol and iopamidol, coupled with generic manufacturing of metrizamide, creates a challenging pricing environment. Manufacturers of generic metrizamide must achieve significant economies of scale to remain profitable.

What is the Market Size and Growth Outlook for Metrizamide?

The global market for iodinated contrast media was valued at approximately $5.5 billion in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 4.5% to reach $7.2 billion by 2028. [2] Metrizamide, as a mature generic product, occupies a segment of this market.

• Current Market Share for Metrizamide: Precise figures are difficult to ascertain due to its generic nature and integration into broader contrast media sales by distributors. However, its market share has likely declined as newer, more advanced contrast agents have gained traction.
• Growth Drivers:
  • Increasing incidence of chronic diseases requiring diagnostic imaging.
  • Growing adoption of CT and angiography in emerging economies.
  • Aging global population, leading to higher demand for medical diagnostics.
• Growth Restraints:
  • Patent expirations of newer agents, leading to increased generic competition across the board.
  • Development of advanced imaging techniques that may reduce contrast agent reliance.
  • Strict regulatory requirements for contrast agent approval and manufacturing.
  • Concerns regarding radiocontrast nephropathy (RCN), leading to efforts to minimize contrast use.

Given its generic status and the availability of newer alternatives, the growth of metrizamide is likely to be modest, potentially below the overall market CAGR for iodinated contrast media. Its market position is sustained by its established safety profile, cost-effectiveness, and widespread availability through generic channels.

What are the Regulatory Considerations for Metrizamide?

Metrizamide, like all pharmaceutical products, is subject to stringent regulatory oversight by health authorities worldwide. Key regulatory considerations include:

• Manufacturing Standards (GMP): Manufacturers must adhere to Good Manufacturing Practices (GMP) to ensure product quality, safety, and consistency. Regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) conduct regular inspections.
• Adverse Event Reporting: Post-market surveillance systems are in place to monitor and report adverse events associated with metrizamide use. This includes reactions ranging from mild hypersensitivity to severe anaphylactic shock and nephrotoxicity.
• Labeling and Packaging: Regulatory agencies mandate specific labeling requirements, including indications, contraindications, warnings, precautions, dosage information, and potential side effects.
• Generic Drug Approval: For generic metrizamide products, manufacturers must demonstrate bioequivalence to the reference listed drug (RLD). This involves rigorous pharmacokinetic and pharmacodynamic studies.
• Environmental Regulations: The disposal of contrast agents and their byproducts is subject to environmental regulations due to the presence of iodine and potential for water contamination.

The regulatory landscape for contrast agents is dynamic. Recent discussions and guidance from bodies like the FDA have focused on strategies to minimize the risk of contrast-induced nephropathy (CIN), which may indirectly influence the market for older contrast agents. [3]

What are the Risks and Opportunities for Investors in Metrizamide?

Investing in metrizamide presents both risks and opportunities, largely dictated by its position as a mature, generic pharmaceutical product.

Risks

• Intense Price Competition: The generic nature of metrizamide results in significant price pressure from multiple manufacturers, eroding profit margins.
• Technological Obsolescence: Newer generations of contrast agents with improved safety profiles, lower osmolality, and specific targeting capabilities may displace metrizamide.
• Market Saturation: The global contrast media market is mature, with limited opportunities for substantial organic growth for established products.
• Regulatory Scrutiny: Increased focus on reducing contrast agent use due to nephrotoxicity concerns could impact overall demand.
• Supply Chain Vulnerabilities: Reliance on specific raw material suppliers or geopolitical instability can disrupt production and distribution.

Opportunities

• Cost-Effective Diagnostic Tool: Metrizamide's affordability makes it an attractive option for healthcare systems in cost-constrained environments or for routine diagnostic procedures.
• Established Market Presence: Its long history of use means established supply chains and a familiar product for healthcare providers.
• Emerging Market Growth: As healthcare access expands in developing nations, demand for essential diagnostic tools like metrizamide may increase.
• Manufacturing Efficiency: Companies with highly optimized manufacturing processes and efficient supply chains can achieve competitive cost advantages.
• Portfolio Diversification: For diversified pharmaceutical companies, metrizamide can contribute stable, albeit modest, revenue streams as part of a broader contrast media portfolio.

The investment thesis for metrizamide is primarily centered on operational efficiency and market penetration in cost-sensitive segments rather than innovation-driven growth.

What is the Future Outlook for Metrizamide?

The future of metrizamide is characterized by its role as a foundational, cost-effective contrast agent within a competitive and evolving diagnostic imaging landscape.

• Continued Use in Specific Markets: Metrizamide will likely retain its utility in certain geographical regions and healthcare systems where cost is a primary consideration. Its use in basic CT and angiography procedures is expected to continue.
• Declining Market Share: It is anticipated that metrizamide's overall market share will gradually decline as newer, more advanced, and potentially safer contrast agents become more widely adopted, especially in high-income countries.
• Focus on Generic Competition: The market will remain dominated by generic manufacturers competing on price and volume. Success will hinge on robust supply chain management and cost control.
• Potential Niche Applications: While primary applications may face pressure, metrizamide might retain specific niche uses where its profile is deemed adequate and cost-effective compared to alternatives.

The long-term outlook suggests metrizamide will remain a relevant, albeit diminishing, contributor to the contrast media market, primarily serving as a budget-friendly option rather than a product driven by innovation or significant market expansion.

Key Takeaways

• Metrizamide is a generic, non-ionic X-ray contrast agent with expired patents, leading to intense price competition.
• Its primary application is in CT imaging, but it faces competition from newer, more advanced contrast agents.
• The global contrast media market is substantial but growing at a moderate pace, with metrizamide's growth likely below the market average.
• Regulatory compliance, particularly GMP, and post-market surveillance are critical for manufacturers.
• Investment risks include intense price competition and technological obsolescence, while opportunities lie in cost-effective solutions for emerging markets and operational efficiencies.
• The future outlook for metrizamide is one of continued but diminishing relevance, serving as a cost-effective option in a competitive landscape.

Frequently Asked Questions

1. What are the primary safety concerns associated with metrizamide?

The primary safety concerns relate to hypersensitivity reactions, including anaphylaxis, and nephrotoxicity, also known as contrast-induced nephropathy (CIN). Patients with pre-existing renal impairment, diabetes, or dehydration are at higher risk.

2. How does metrizamide compare in cost to newer contrast agents like iohexol or iopamidol?

Metrizamide, as a generic product with expired patents, is generally significantly less expensive than branded or even generic versions of iohexol and iopamidol. This cost advantage is a key factor in its continued use in certain settings.

3. Can metrizamide be used in patients with iodine allergies?

Patients with a known hypersensitivity to iodine compounds are generally advised against the use of metrizamide. However, a history of mild iodine allergy does not always contraindicate its use, and a risk assessment by a healthcare professional is necessary.

4. What are the main manufacturing challenges for metrizamide producers?

Key manufacturing challenges include ensuring consistent purity and sterility, managing raw material sourcing and costs for iodinated compounds, and adhering to stringent GMP regulations. Achieving cost-efficiency through scale and process optimization is paramount for profitability.

5. What is the expected impact of advancements in MRI and ultrasound on the demand for metrizamide?

Advancements in MRI and ultrasound offer alternative or complementary diagnostic modalities. While they do not directly replace CT imaging in all cases, increased adoption of these technologies for specific indications could indirectly reduce the overall demand for X-ray contrast agents like metrizamide by shifting diagnostic pathways.

---

Citations

[1] Grand View Research. (2023). Iodinated Contrast Media Market Size, Share & Trends Analysis Report By Type, By Application, By Region, And Segment Forecasts, 2023 - 2030. Retrieved from https://www.grandviewresearch.com/industry-analysis/iodinated-contrast-media-market

[2] Mordor Intelligence. (2023). Contrast Media Market - Growth, Trends, COVID-19 Impact, and Forecasts (2023 - 2028). Retrieved from https://www.mordorintelligence.com/industry-reports/contrast-media-market

[3] Food and Drug Administration. (2023, September 27). FDA Drug Safety Communication: FDA recommends strategies to mitigate risk of contrast-induced nephropathy. Retrieved from https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-recommends-strategies-mitigate-risk-contrast-induced-nephropathy