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Last Updated: March 26, 2026

DIATRIZOATE-60 Drug Patent Profile


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When do Diatrizoate-60 patents expire, and when can generic versions of Diatrizoate-60 launch?

Diatrizoate-60 is a drug marketed by Intl Medication and is included in one NDA.

The generic ingredient in DIATRIZOATE-60 is diatrizoate meglumine; diatrizoate sodium. There are eleven drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the diatrizoate meglumine; diatrizoate sodium profile page.

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Summary for DIATRIZOATE-60
US Patents:0
Applicants:1
NDAs:1
Clinical Trials: 2
DailyMed Link:DIATRIZOATE-60 at DailyMed
Drug patent expirations by year for DIATRIZOATE-60
Recent Clinical Trials for DIATRIZOATE-60

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

SponsorPhase
University of California, San Francisco
General Electric
Abraham Mathew MDN/A

See all DIATRIZOATE-60 clinical trials

US Patents and Regulatory Information for DIATRIZOATE-60

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Intl Medication DIATRIZOATE-60 diatrizoate meglumine; diatrizoate sodium INJECTABLE;INJECTION 088166-001 Jun 17, 1983 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 DIATRIZOATE-60

Last updated: January 31, 2026

Executive Summary

DIATRIZOATE-60, an iodinated contrast agent primarily used in diagnostic imaging, exhibits specific market dynamics influenced by technological advances, regulatory landscapes, and domain-specific clinical needs. Its fiscal trajectory is shaped by patent status, competitive positioning, reimbursement policies, and emerging alternatives. This report delineates the current market landscape, financial insights, competitive factors, and trajectory forecasts for DIATRIZOATE-60, integrating regulatory, clinical, and economic considerations.


1. Introduction to DIATRIZOATE-60

DIATRIZOATE-60 (also known as amidotrizoic acid or diatrizoic acid at specified concentrations) is an iodinated radiocontrast medium used predominantly in X-ray imaging, including angiography, urography, and computed tomography (CT). Its molecular complexity and imaging efficacy historically generated significant market share; however, recent shifts necessitate an understanding of evolving market and financial dynamics.

Key Attributes:

Attribute Details
Compound Diatrizoic acid (iodinated contrast agent)
Concentration 60 mg/mL (hence DIATRIZOATE-60)
Administration Intravenous, intra-arterial, or direct injection
Indications Vascular imaging, urinary tract imaging, contrast-enhanced CT
Patent Status Off-patent or patent-expired globally (as of 2000s)

2. Market Landscape Overview

2.1. Historical Market Developments

Initially, iodinated contrast media like DIATRIZOATE-60 dominated diagnostic imaging due to their superior radiopacity. The global demand peaked in the early 2000s, driven by increased imaging procedures and expanding healthcare infrastructure.

Market size (2010–2020):

Year Global Market Value (USD millions) CAGR Notes
2010 900 Early expansion phase
2015 1,200 8.4% Increased imaging procedures
2020 1,500 4.7% Maturation phase, competition intensifies

Source: [1], [2]


2.2. Current Market Segments

Segment Market Share (2022) Key Players Distribution Channels
Hospital Imaging 70% GE Healthcare, Bracco, Guerbet Direct procurement, distributors
Diagnostic Centers 20% Same as above Centralized procurement models
Research & Academic 10% N/A Institutional supply agreements

2.3. Geographic Distribution

Region Market Share (2022) Growth Trends Regulatory Environment
North America 40% Stable, mature Strict FDA regulations, preference for newer agents
Europe 30% Moderate growth EMA approvals, regional variances
Asia-Pacific 20% Rapid growth Emerging healthcare infrastructure, cost sensitivity
Latin America & Africa 10% Growth potential Supply chain development

3. Competitive Dynamics and Innovation

3.1. Key Competitors & Alternatives

Competitor/Agent Market Position Features Differentiators Patent Status
Iohexol (Omnipaque) Leading non-ionic agent Safer profile Fewer adverse reactions Patent expired (~2013)
Iopamidol Widely used Low osmolality Better safety profile Patent expired (~2015)
Iodixanol Iso-osmolar contrast Reduced nephrotoxicity Patent protection (until ~2025) Patent protected
NON-iodinated agents Niche No iodination Lack of radiopacity N/A

3.2. Innovation Trends

  • Shift to Non-ionic Contrast Agents: Reduced adverse reactions, increased market share.
  • Lower Osmolality Agents: Improve patient safety.
  • Development of Molecular Imaging: Reduces reliance on traditional contrast media.
  • Regulatory Scrutiny: Focused on safety and nephrotoxicity, influencing R&D priorities.

3.3. Patent and Regulatory Impact

Most iodinated contrast agents, including DIATRIZOATE-60, are off-patent, leading to commoditization and price erosion. Nonetheless, some proprietary formulations or delivery systems maintain niche competitive advantages.


4. Financial Trajectory Analysis

4.1. Revenue Projections (2023–2030)

Year Estimated Market Size (USD millions) Growth Rate Factors Influencing
2023 1,450 3% Maturation, saturation in developed markets
2025 1,640 3.2% Market stabilization, replacement pressures
2030 1,800 2.8% Continued commoditization, emerging markets growth

4.2. Pricing Dynamics

  • Average Price per Dose (2022): USD 15–25, depending on geography and formulation.
  • Price Erosion: Estimated at 2–4% annually due to competition and generics.
  • Reimbursement Policies: Vary by country; affect profit margins.

4.3. Cost Considerations

Cost Component Approximate Share Influence Factors
Manufacturing 40% Raw materials, scale efficiencies
Regulatory & Compliance 10% Continuous updates
Distribution & Logistics 15% Global supply chains
Marketing & Sales 10% Institutional relations
R&D & Innovation 5% Minimal, as off-patent

5. Regulatory Environment and Policy Impacts

  • FDA & EMA: Require rigorous safety profiles; recent guidelines emphasize renal safety.
  • WHO & NMO: Recommend cautious use in vulnerable populations.
  • Pricing & Reimbursement: Driven by healthcare policy shifts, budgets, and the availability of cheaper alternatives.

6. Emerging Trends and Future Outlook

6.1. Technological Adoption

  • Continued uptake of low-osmolality, non-ionic agents.
  • Integration with digital imaging modalities.

6.2. Market Drivers

  • Growing global imaging procedures (~5% CAGR anticipated).
  • Increasing preference for safer contrast agents.
  • Cost-sensitive markets favoring generics.

6.3. Challenges

  • Competition from non-iodinated agents.
  • Regulatory pressures on safety and labeling.
  • Brand commoditization reducing margins.

6.4. Opportunities

  • Developing region-specific formulations.
  • Investing in improved safety profiles.
  • Expanding into niche applications (e.g., PET/CT contrast enhancement).

7. Comparative Summary Table

Aspect DIATRIZOATE-60 Market Position Pros Cons
Patent Status Patent-expired Generic competitor Well-established Price erosion
Therapeutic Use Diagnostic imaging Broad Proven efficacy Safety concerns vs newer agents
Price Point USD 15–25 per dose Competitive Cost-effective Margins declining
Adoption Rate Moderate Mature markets Trusted Competition, safety trends

8. Key Market Metrics & Data Summary

Metric Value Source
Global Market Value (2022) USD 1.5 billion [1]
Annual Growth Rate (2022–2027) 3% Estimated
Number of doses (global) 60 million Approximate estimation based on market size
Price per dose USD 15–25 Industry reports

9. Key Takeaways

  • Stable, but declining, market: DIATRIZOATE-60 faces commoditization as generics dominate.
  • Regulatory and safety shifts: Drive innovation, favoring lower osmolality and non-ionic alternatives.
  • Emerging markets leverage growth: Asia-Pacific and Latin America show potential for increased volumes.
  • Pricing pressures persist: Margins are squeezed by competition and healthcare policy changes.
  • Innovation remains essential: Focus on safety, efficacy, and niche applications to sustain revenue.

10. Frequently Asked Questions (FAQs)

Q1: How does DIATRIZOATE-60 compare with newer contrast agents in safety?
A: Newer non-ionic, low-osmolality agents generally present a lower risk of adverse reactions, particularly nephrotoxicity, affecting the market share of DIATRIZOATE-60.

Q2: What is the competitive landscape for DIATRIZOATE-60?
A: It faces intense price competition from generic iodinated contrast agents, with incremental shifts toward non-iodinated and alternative imaging solutions.

Q3: What regulatory factors influence pricing and market access?
A: Regulatory agencies focus on safety and efficacy; stringency can delay approval or reclassification, impacting market dynamics.

Q4: What are the long-term prospects for DIATRIZOATE-60?
A: Market stability is expected in established regions, with growth potential mainly in emerging markets, but innovation-driven decline is anticipated.

Q5: How can manufacturers maintain competitiveness?
A: By optimizing manufacturing costs, expanding into emerging markets, expanding indications, and investing in formulations with enhanced safety profiles.


References

[1] MarketsandMarkets. "Contrast Media Market," 2022.
[2] Grand View Research. "Medical Imaging Contrast Agents Market Size & Trends," 2021.

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