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Last Updated: December 12, 2025

METRIZAMIDE - Generic Drug Details


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What are the generic 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.

There is one drug master file entry for metrizamide.

Summary for METRIZAMIDE
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 1
Raw Ingredient (Bulk) Api Vendors: 36
DailyMed Link:METRIZAMIDE at DailyMed
Medical Subject Heading (MeSH) Categories for METRIZAMIDE

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 017982-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-003 Sep 12, 1983 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-004 Sep 12, 1983 DISCN No No ⤷  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

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 3,701,771 ⤷  Get Started Free
Ge Healthcare AMIPAQUE metrizamide INJECTABLE;INJECTION 017982-002 Approved Prior to Jan 1, 1982 3,701,771 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Market Dynamics and Financial Trajectory for Metrizamide

Last updated: July 31, 2025

Introduction

Metrizamide, a water-soluble contrast agent historically utilized in neuroimaging procedures such as myelography, has experienced a significant decline in clinical use due to advancements in imaging technology and concerns regarding safety profiles. This comprehensive analysis explores the current market landscape, key drivers and restraints, and the projected financial trajectory of Metrizamide, shedding light on factors influencing its positioning within the pharmaceutical and medical imaging sectors.

Historical Context and Clinical Utilization

Initially introduced in the 1970s, Metrizamide gained prominence as a diagnostic agent for imaging the central nervous system (CNS). Its favorable properties, including high radiopacity and compatibility with various imaging modalities, established it as a cornerstone in neurodiagnostics. However, the advent of MRI and CT scans featuring non-invasive imaging capabilities significantly reduced reliance on intraoperative contrast agents like Metrizamide [1].

Despite this, some regions and clinical settings continue to utilize Metrizamide, primarily due to infrastructure limitations, regulatory constraints, and the inertia associated with established protocols. Nonetheless, the global utilization of Metrizamide has sharply declined, aligning with evolving clinical guidelines favoring safer, non-iodinated contrasts.

Market Dynamics

Demand Drivers

  1. Decline of Traditional Myelography Procedures: The global shift towards MRI-based diagnostics has drastically reduced the demand for contrast agents used in myelography. According to recent data, the number of myelographic procedures has decreased by over 80% in developed markets over the past decade [2].

  2. Limited Adoption in Emerging Markets: Despite overall decline, some developing regions continue to rely on traditional imaging modalities, including myelography, due to resource constraints. These markets account for a minimal yet persistent demand for Metrizamide.

  3. Regulatory Status and Safety Profile: Metrizamide's safety concerns—such as neurotoxicity and allergic reactions—have led to regulatory bans or restrictions in several jurisdictions. Conversely, countries with outdated regulatory frameworks or limited access to newer agents may still permit its clinical use.

  4. Competition from Safer Alternatives: The rise of MRI contrast agents—gadolinium-based and newer non-iodinated compounds—has led to a paradigm shift. These alternatives offer enhanced safety and image quality, further suppressing Metrizamide's market viability.

Restraints

  • Safety and Toxicity Concerns: Neurotoxicity risks associated with Metrizamide curtailed its broader acceptance. High-profile adverse events prompted regulatory restrictions in multiple regions.

  • Regulatory Withdrawals: Agencies such as the FDA and EMA have either withdrawn or deprecated Metrizamide from their approved lists, decreasing global availability [3].

  • Innovation in Medical Imaging: The proliferation of high-resolution MRI and CT technologies diminishes the need for contrast agents reliant on invasive or potentially hazardous procedures.

  • Economic Factors: The cost of compliant contrast agents continues to lower due to technological advancements, making older agents like Metrizamide less economically attractive.

Opportunities

Although the outlook appears bleak, niche applications or reformulations could stabilize or extend the utility timeline. For instance, reformulation efforts aimed at improving safety profiles might rejuvenate interest, especially in resource-limited settings.

Financial Trajectory and Market Forecast

Current Market Size

The global market for neuroimaging contrast agents was valued at approximately USD 1.3 billion in 2022, with iodine-based and gadolinium-based agents dominating. Metrizamide constitutes a negligible fraction, primarily serving a handful of legacy applications and local markets.

Market Decline Trends

Analyst projections indicate a compound annual decline rate (CAGR) of approximately 10-15% in the contrast agent segment involving traditional agents like Metrizamide until 2030. This steep decline reflects the rapid obsolescence driven by technological innovation and safety considerations.

Future Outlook

  • Low or Negative Growth: Metrizamide's market share is expected to diminish to near zero in developed markets by the early 2030s.
  • Potential for Niche Market Resurgence: In select territories with regulatory constraints or infrastructural limitations, a minimal residual demand may persist, estimated at less than USD 10 million globally by 2030, primarily fueled by legacy procedures.

Impact of Regulatory and Safety Developments

The trajectory hinges largely on regulatory decisions. Any reversal or relaxation of restrictions—potentially driven by reformulation or safety improvements—could induce localized demand spikes, though global impact remains unlikely.

Investment and Industry Perspective

Major pharmaceutical companies and contrast media manufacturers are unlikely to invest significantly in Metrizamide development given its declining relevance and safety profile. Instead, resources favor innovation in safer, more effective contrast agents and imaging technologies.

Conclusion

The market for Metrizamide is characterized by a steep decline, driven by advances in non-invasive imaging, safety concerns, and regulatory bans. Its current use is confined largely to legacy applications and constrained markets, with a bleak financial outlook dominated by diminutive demand and minimal growth prospects. Stakeholders focusing on diagnostic imaging should consider the broader transition towards safer, technology-driven solutions, rendering Metrizamide increasingly obsolete.


Key Takeaways

  • Metrizamide, once a mainstay in neuroimaging, faces near-complete obsolescence in favor of MRI and safer contrast agents.
  • Regulatory constraints and safety concerns have eradicated most markets for Metrizamide, with remaining demand limited to legacy or resource-constrained settings.
  • The global market for Metrizamide is projected to experience a compounded decline at approximately 10-15% CAGR through 2030.
  • Future prospects are minimal, with potential niche markets unlikely to sustain significant revenue streams.
  • Industry focus should pivot toward innovation in non-invasive, low-risk imaging contrasts rather than reinvestment in aging agents like Metrizamide.

FAQs

Q1: Why has Metrizamide's use declined globally?
A1: The decline is primarily due to the advent of MRI technology, which obviates the need for intraoperative contrast agents, combined with safety concerns such as neurotoxicity and allergic reactions associated with Metrizamide.

Q2: Are there any regions where Metrizamide is still used?
A2: Yes. Limited use persists in some developing countries with resource constraints and regulatory frameworks that are less restrictive, but overall demand remains minimal.

Q3: Could reformulation or new formulations revive Metrizamide's market?
A3: While theoretically possible, reformulation efforts face significant scientific and regulatory hurdles, and current safety concerns make revival unlikely.

Q4: How does Metrizamide compare to modern contrast agents in terms of safety?
A4: Modern contrast agents, such as gadolinium-based compounds, have better safety profiles with fewer neurotoxic risks, leading to widespread adoption over agents like Metrizamide.

Q5: What should investors or healthcare providers consider regarding Metrizamide?
A5: Given its declining market and safety issues, stakeholders should focus on advanced, non-invasive imaging modalities and contrast agents, considering Metrizamide obsolete in mainstream medical practice.


References

[1] Lee, Y. et al. (2018). Evolution of Neuroimaging Contrast Agents: From Metrizamide to Modern MRI. Journal of Medical Imaging, 5(3), 031203.
[2] Smith, A. (2020). Trends in Myelography Procedures and Contrast Agent Usage. Neurodiagnostics Today.
[3] European Medicines Agency. (2021). Summary of Safety Concerns for Water-soluble Contrast Agents.

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