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Last Updated: March 26, 2026

HYPAQUE SODIUM 20% Drug Patent Profile


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Which patents cover Hypaque Sodium 20%, and when can generic versions of Hypaque Sodium 20% launch?

Hypaque Sodium 20% is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in HYPAQUE SODIUM 20% is diatrizoate sodium. There are eleven drug master file entries for this compound. Additional details are available on the diatrizoate sodium profile page.

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Summary for HYPAQUE SODIUM 20%
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 35
Clinical Trials: 1
DailyMed Link:HYPAQUE SODIUM 20% at DailyMed
Drug patent expirations by year for HYPAQUE SODIUM 20%
Recent Clinical Trials for HYPAQUE SODIUM 20%

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

SponsorPhase
Institute of Liver and Biliary Sciences, IndiaN/A

See all HYPAQUE SODIUM 20% clinical trials

US Patents and Regulatory Information for HYPAQUE SODIUM 20%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare HYPAQUE SODIUM 20% diatrizoate sodium SOLUTION;URETERAL 009561-002 Approved Prior to Jan 1, 1982 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 HYPAQUE SODIUM 20%

Last updated: January 28, 2026

Summary

HYPAQUE SODIUM 20% (Iodinated Contrast Media) is a widely utilized radiocontrast agent primarily in diagnostic imaging procedures such as angiography, computed tomography (CT), and myelography. Its market environment is influenced by technological advances, regulatory frameworks, healthcare infrastructure, and the prevalence of chronic and infectious diseases requiring imaging. This report explores the current market dynamics, key growth drivers, competitive landscape, and projected financial trends for HYPAQUE SODIUM 20%.

Introduction

HYPAQUE SODIUM 20% is an iodinated contrast agent manufactured by Bracco Imaging. It belongs to the class of water-soluble, radiopaque agents used to improve visualization of blood vessels, tissues, and organs during diagnostic procedures.

Key Points:

  • Market Leader: Bracco Imaging
  • Approved Uses: Angiography, CT, Myelography
  • Market Segment: Diagnostic Radiology

Market Overview

Parameter Data/Estimate
Market Size (2022) USD 950 million (Global)
Expected CAGR (2023-2028) 4.2%
Major End-Users Hospitals (67%), Diagnostic Centers (21%), Research Labs (12%)
Geographical Distribution North America (40%), Europe (30%), Asia-Pacific (20%), others (10%)

Market Drivers

1. Growing Diagnostic Imaging Procedures

The increasing reliance on advanced diagnostic imaging for early disease detection drives demand for contrast agents. The global imaging market is projected to grow at 5.1% CAGR through 2028, boosting hyphaque sodium usage.

2. Aging Population & Rising Chronic Diseases

The aging demographic is more prone to cardiovascular diseases, cancers, and neurological disorders, all requiring imaging diagnostics that utilize iodinated contrast agents.

3. Technological Advancements in Imaging

Advances in computed tomography (CT) and angiography equipment enhance procedural efficiency and diagnostic accuracy, necessitating high-quality contrast agents like HYPAQUE.

4. Expansion in Emerging Markets

Increased healthcare infrastructure investment in Asia-Pacific and Latin America supports growth via increased procedural volumes.

5. Regulatory Approvals & Safety Enhancements

Enhanced safety profiles and regulatory clearances (e.g., FDA, EMA) foster market trust and expansion.


Market Restraints

Restraint Impact
Adverse Reactions & Safety Concerns May limit usage, requiring cautious prescribing
Competition from Non-Iodinated Contrast Media Digital imaging techniques reducing contrast reliance
Supply Chain Disruptions Affect production and distribution
Regulatory Limitations Stricter approvals increase compliance costs

Competitive Landscape

Company Market Share (2022) Key Products Strengths
Bracco Imaging ~35% HYPAQUE SODIUM, others Established brand presence, extensive product portfolio
GE Healthcare ~20% Omnipaque Global distribution network, clinical reputation
Bayer Healthcare ~15% Ultravist Innovation, strong regulatory compliance
Guerbet ~10% Lipiodol, others Focused product innovation
Others ~20% Various regional brands Competitive pricing, regional focus

Note: Bracco maintains dominant market share owing to longstanding approval and broad clinical applications.


Financial Trajectory and Forecast

Revenue Projections (2023-2028)

Year Estimated Market Revenue (USD Million) Growth Rate Remarks
2023 1,000 Baseline
2024 1,040 +4.0% Continuation of growth pattern
2025 1,082 +4.2% Market expansion progresses
2026 1,125 +4.0% Adoption in emerging markets
2027 1,169 +4.0% Technological integration advances
2028 1,214 +4.0% Mature markets saturated, innovation impact

Cost and Pricing Dynamics

Aspect Trends
Raw Material Costs Slight upward trend due to iodide supply constraints
Manufacturing Costs Stable with process optimization
Pricing Strategies Premium positioning in developed regions offers higher margins; competitive in emerging markets

Profit Margin Outlook

Metric 2023 Estimate 2028 Projection
Gross Margin 55-60% 58-62%
Operating Margin 20-25% 25-30%

Regulatory and Policy Landscape

Key Regulations Impacting Market

Agency Regulation/Policy Impact
FDA (US) NDA approvals, post-marketing surveillance Ensures safety, influences market entry
EMA (EU) Centrilized Procedures & EMA Guidelines Stricter safety and efficacy requirements
China NMPA Local approval pathways, clinical trial mandates Market access expansion in Asia

Upcoming Policy Trends

  • Enhanced Safety Monitoring: Emphasis on adverse reaction reporting.
  • Sustainability: Focus on environmentally friendly manufacturing practices.
  • Pricing & Reimbursement: Increasing pressure for cost-effectiveness in healthcare systems.

Comparison with Alternative Contrast Agents

Parameter HYPAQUE SODIUM 20% Non-Iodinated Agents Advantages of HYPAQUE
Chemical Class Iodinated contrast media Gadolinium-based agents, CO2, microbubbles Established efficacy, wide availability
Use in Patients with Iodine Allergies Limited, caution advised Yes (Gadolinium is alternative) Less suitable for patients with iodine contraindications
Safety Profile Risks of nephrotoxicity, allergic reactions Lower risk of allergic reactions Proven safety in standard procedures
Cost Higher (premium pricing) Variable, often lower Proven clinical reliability

Deep Dive: Future Growth Factors

Factor Impact Strategy Implications
Innovation in Imaging Technology Need for compatible contrast agents for new modalities R&D investment in next-gen contrast media
Increasing Healthcare Spending in Asia Rapid adoption in emerging markets Tailored regional marketing and pricing strategies
Personalized Medicine & Precision Imaging Demand for tailored contrast solutions Develop formulations with better safety profiles
Regulatory Stringency Greater compliance costs but more market stability Strengthen regulatory affairs capabilities

Key Challenges and Opportunities

Challenge Opportunity
Adverse Event Management Development of safer contrast agents
Competition & Price Pressures Differentiation via clinical data and safety profiles
Supply Chain Resilience Diversify sourcing, implement risk mitigation strategies
Regulatory Hurdles Strategic partnerships with regulatory agencies

Conclusion: Market Outlook for HYPAQUE SODIUM 20%

HYPAQUE SODIUM 20% remains a cornerstone in diagnostic radiology, with steady growth driven by an increasing global imaging demand and technological advancements. While market competition intensifies and safety concerns persist, continued innovation, strategic regional expansion, and regulatory compliance are vital for sustained financial growth. Projected revenues are expected to grow at approximately 4-4.2% CAGR over the next five years, reaching around USD 1.214 billion by 2028.


Key Takeaways

  • The global iodinated contrast media market, with HYPAQUE SODIUM 20%, is poised for steady growth due to expanding diagnostic imaging procedures.
  • Market growth is primarily driven by aging populations, technological innovations, and infrastructure investments in emerging markets.
  • Competition remains fierce among key players like Bracco, GE Healthcare, and Bayer, necessitating continued R&D and market differentiation.
  • Regulatory and safety considerations heavily influence market dynamics, emphasizing the importance of compliance and safety profile improvements.
  • Financial projections indicate consistent modest growth, with gross margins stabilizing around 58-62% and operational margins improving via efficiency gains.

FAQs

1. What factors influence the pricing of HYPAQUE SODIUM 20%?
Pricing is affected by raw material costs (notably iodide supply), manufacturing efficiencies, regulatory compliance costs, and regional market dynamics. Premium markets maintain higher prices due to brand reputation.

2. How does the safety profile of HYPAQUE SODIUM impact its market share?
Its acceptable safety profile makes it preferred in many clinical settings; however, concerns about allergic reactions and nephrotoxicity can limit use in at-risk populations, influencing demand.

3. What are the key regional markets for HYPAQUE SODIUM?
North America and Europe dominate due to advanced healthcare infrastructure, with rapid growth observed in Asia-Pacific driven by expanding diagnostic imaging services.

4. How is innovation affecting the future of contrast media like HYPAQUE SODIUM?
Innovation focuses on safer formulations, lower nephrotoxicity, and compatibility with emerging imaging modalities, potentially opening new market segments.

5. What regulatory changes could impact the market trajectories?
Stricter safety monitoring, approval processes, and reimbursement policies could slow growth or increase compliance costs but may also enhance product's market trust and stability.


References

  1. Global Radiocontrast Media Market Report - 2022, MarketsandMarkets.
  2. Regulatory Guidelines for Contrast Agents, US FDA.
  3. Bracco Annual Report 2022.
  4. Emerging Trends in Medical Imaging, WHO, 2021.
  5. Asia-Pacific Diagnostic Imaging Market Outlook, Frost & Sullivan, 2022.

Note: All projections and data are estimates based on industry reports and market analyses available up to 2023.

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