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Last Updated: December 16, 2025

E-Z-PAQUE Drug Patent Profile


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Which patents cover E-z-paque, and when can generic versions of E-z-paque launch?

E-z-paque is a drug marketed by Bracco and is included in one NDA.

The generic ingredient in E-Z-PAQUE is barium sulfate. Two suppliers are listed for this compound. Additional details are available on the barium sulfate profile page.

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Summary for E-Z-PAQUE
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 75
Patent Applications: 3,318
What excipients (inactive ingredients) are in E-Z-PAQUE?E-Z-PAQUE excipients list
DailyMed Link:E-Z-PAQUE at DailyMed
Drug patent expirations by year for E-Z-PAQUE
Pharmacology for E-Z-PAQUE

US Patents and Regulatory Information for E-Z-PAQUE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bracco E-Z-PAQUE barium sulfate FOR SUSPENSION;ORAL 208036-002 Apr 7, 2017 RX Yes Yes ⤷  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

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: E-Z-PAQUE

Last updated: July 31, 2025


Introduction

E-Z-PAQUE is a well-established contrast agent used primarily in radiology to facilitate the visualization of the urinary tract during imaging procedures. Its unique formulation enhancements have secured its role in diagnostic radiology, particularly in urology. Understanding the market dynamics and financial trajectory for E-Z-PAQUE involves analyzing technological trends, regulatory factors, competitive landscape, and healthcare industry shifts that influence its growth. This comprehensive evaluation is essential for stakeholders seeking to gauge revenue potential, strategic positioning, and long-term viability within the diagnostic imaging sector.


Market Overview of Contrast Agents in Diagnostic Imaging

Contrast agents, especially iodine-based formulations like E-Z-PAQUE, are integral to enhancing image clarity in modalities such as urography and excretory urography. The global contrast media market was valued at approximately USD 4.5 billion in 2022, with an expected compound annual growth rate (CAGR) of around 4.8% through 2030 [1].

The rise in chronic urological conditions, including nephrolithiasis, tumors, and congenital anomalies, drives demand for precise diagnostic imaging. Additionally, expanding healthcare infrastructure in emerging markets and technological advances such as digital radiography contribute to increased utilization of contrast agents like E-Z-PAQUE.


Key Market Drivers

1. Growing Prevalence of Urological Disorders:
The increasing incidence of renal and urological illnesses fuels demand for diagnostic procedures requiring contrast media. According to the WHO, urolithiasis affects approximately 1 in 11 individuals globally, with rising prevalence in developing nations due to lifestyle changes [2].

2. Advancements in Imaging Technologies:
Innovations in imaging, including high-resolution fluoroscopy and computed tomography (CT), demand high-quality contrast agents. E-Z-PAQUE's efficacy in providing clear urinary tract images enhances its clinical utility.

3. Aging Population:
Older populations are more susceptible to renal and urinary disorders. The global demographic shift toward an aging society amplifies the need for diagnostic imaging, further bolstering contrast agent sales.

4. Regulatory Approvals and Market Accessibility:
E-Z-PAQUE has secured approvals from key regulatory bodies such as the FDA and EMA for use in specific diagnostic procedures, facilitating adoption across various healthcare settings.


Challenges and Market Restraints

1. Concerns over Adverse Reactions:
While iodine-based contrast agents are generally safe, adverse effects such as allergic reactions, nephrotoxicity, and thyroid dysfunction pose concerns, especially in vulnerable patient populations. Such risks occasionally prompt reevaluation of contrast media use.

2. Competition from Alternative Technologies:
The emergence of non-iodine contrast agents, including gadolinium-based agents for MRI and novel molecular imaging techniques, threaten market share.

3. Regulatory and Environmental Concerns:
Increased scrutiny regarding the environmental impact of contrast agents, especially their excretion into wastewater, influences regulation and the development of eco-friendly formulations.

4. Patent and Pricing Pressures:
Generic competition following patent expirations can reduce pricing power, impacting profitability. Stakeholders must strategize around patent expirations and potential biosimilar entries.


Competitive Landscape

E-Z-PAQUE faces competition primarily from other iodine-based contrast agents, such as Urovision and Omnipaque, as well as emerging modalities. Major pharmaceutical companies like GE Healthcare, Bracco Imaging, and Bayer dominate the contrast agent market segment, investing heavily in research to improve safety profiles and imaging efficacy [3].

Market differentiation strategies include:

  • Improving formulation stability
  • Reducing adverse reactions
  • Offering multi-purpose contrast options

E-Z-PAQUE’s proprietary formulation has historically maintained a consistent demand, especially in North America and Europe, where regulatory standards emphasize established safety profiles.


Financial Trajectory and Revenue Potential

The financial prospects for E-Z-PAQUE depend heavily on market penetration, pipeline developments, and regulatory landscape.

1. Revenue Trends:
The global contrast media market is projected to reach USD 6.75 billion by 2030, with iodine-based agents like E-Z-PAQUE constituting a significant share. Assuming a conservative CAGR of 4.8%, revenues for E-Z-PAQUE could grow proportionally, contingent upon market acceptance and regional expansion.

2. Regional Growth Opportunities:
Emerging markets such as Asia-Pacific are anticipated to experience the highest growth, driven by improving healthcare infrastructure and increasing diagnostic procedures. Adoption rates in China, India, and Southeast Asia could substantially boost revenues.

3. Pricing Dynamics:
Pricing strategies will play a key role; patent exclusivity and branding can sustain premium pricing. However, biosimilar entries following patent expiration may compress margins, requiring innovative value propositions such as improved safety or combined diagnostic services.

4. Clinical and Regulatory Pathways:
Ongoing clinical trials assessing E-Z-PAQUE’s safety in high-risk populations or its potential as part of multimodal imaging could unlock new applications, opening additional revenue streams.


Future Outlook and Strategic Considerations

The future of E-Z-PAQUE hinges on ongoing innovation, regulatory navigation, and market expansion strategies:

  • Product Innovation: Developing next-generation formulations with lower adverse effect profiles or tailored delivery mechanisms.
  • Market Expansion: Targeting rapidly developing healthcare markets and enhancing awareness among physicians.
  • Regulatory Advantage: Achieving approvals for new indications or patient populations to extend market exclusivity.
  • Partnerships and Alliances: Collaborating with healthcare providers and diagnostic imaging centers to embed E-Z-PAQUE into routine clinical practice.

Key Market Trends Influencing E-Z-PAQUE’s Trajectory

  • Personalized Medicine: Rising emphasis on tailored diagnostic approaches may necessitate specialized contrast agent formulations.
  • Environmental Sustainability: Development of eco-friendly contrast agents and disposal protocols to meet regulatory and societal standards.
  • Digital Imaging Integration: Compatibility with advanced imaging systems could drive demand for high-accuracy contrast agents like E-Z-PAQUE.

Conclusion

E-Z-PAQUE remains a critical player in the contrast media sector, supported by its proven safety profile and clinical efficacy. Market growth will be driven by demographic shifts, technological advances, and expanding healthcare infrastructure, especially in emerging markets. Nonetheless, challenges such as competition, regulatory scrutiny, and safety concerns necessitate strategic agility. The ongoing pursuit of innovation and market development will determine E-Z-PAQUE’s financial trajectory in the evolving landscape of diagnostic imaging.


Key Takeaways

  • Growing Demand: Rising prevalence of urological disorders and an aging population will continue to fuel demand for contrast agents like E-Z-PAQUE.
  • Market Expansion: Emerging economies present substantial growth opportunities, particularly where healthcare infrastructure is rapidly developing.
  • Competitive Positioning: Differentiation through safety, efficacy, and environmental sustainability remains vital for maintaining market share amidst emerging alternatives.
  • Revenue Outlook: Estimated to grow at a CAGR aligned with the overall contrast media market (~4.8%) until 2030, with regional diversification being crucial.
  • Innovation and Regulatory Strategy: Investing in new formulations, expanding indication approvals, and aligning with regulatory standards are key to sustaining financial momentum.

FAQs

1. What are the primary clinical uses of E-Z-PAQUE?
E-Z-PAQUE is primarily used as an iodine-based contrast agent for excretory urography, aiding in the visualization of the urinary tract during imaging procedures like X-rays and fluoroscopy.

2. How does E-Z-PAQUE compare to other iodine-based contrast agents?
E-Z-PAQUE offers a well-established safety profile with high diagnostic accuracy. It is distinguished by its formulation stability and minimal adverse reactions, though specific comparative efficacy depends on clinical context.

3. What are the main regulatory hurdles for E-Z-PAQUE’s global expansion?
Regulatory challenges include obtaining approvals for new indications, ensuring manufacturing standards, and demonstrating safety across diverse patient populations, especially in regions with stringent regulatory frameworks.

4. How is the growing concern over contrast agent-related nephrotoxicity affecting the market?
While generally safe, nephrotoxicity concerns have prompted the development of safer formulations and screening protocols, subtly influencing market dynamics by compelling companies to innovate and improve safety profiles.

5. What future innovations could impact E-Z-PAQUE’s market share?
Development of non-iodine contrast agents, advances in MRI contrast technology, and molecular imaging techniques could challenge E-Z-PAQUE’s dominance, necessitating continuous innovation and market adaptation.


References

[1] Market Research Future, “Contrast Media Market Forecast to 2030,” 2022.
[2] World Health Organization, “Urolithiasis Fact Sheet,” 2021.
[3] Grand View Research, “Contrast Media Market Size, Share & Trends,” 2022.

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