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Last Updated: December 15, 2025

UROVIST MEGLUMINE DIU/CT Drug Patent Profile


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When do Urovist Meglumine Diu/ct patents expire, and when can generic versions of Urovist Meglumine Diu/ct launch?

Urovist Meglumine Diu/ct is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in UROVIST MEGLUMINE DIU/CT is diatrizoate meglumine. There are eleven drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the diatrizoate meglumine profile page.

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Summary for UROVIST MEGLUMINE DIU/CT
Drug patent expirations by year for UROVIST MEGLUMINE DIU/CT

US Patents and Regulatory Information for UROVIST MEGLUMINE DIU/CT

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare UROVIST MEGLUMINE DIU/CT diatrizoate meglumine INJECTABLE;INJECTION 087739-001 Sep 23, 1982 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

Market Dynamics and Financial Trajectory for Urovist Meglumine Diu/CT

Last updated: July 29, 2025


Introduction

Urovist Meglumine Diu/CT (also known as Urovist 370 or Urovist Meglumine) is a nephrostogram contrast agent used predominantly in urological imaging to visualize the urinary tract during diagnostic procedures. As a contrast agent based on meglumine diatrizoate, it provides enhanced imaging clarity, facilitating accurate diagnosis and treatment planning for urinary system disorders. This article examines the emerging market landscape, key drivers, challenges, and the financial trajectory that shape the future of Urovist Meglumine Diu/CT in the pharmaceutical and medical imaging sectors.


Market Overview

The global market for urological contrast agents, including Urovist Meglumine Diu/CT, is experiencing steady growth driven by advancements in imaging technologies, rising prevalence of urinary tract disorders, and expanded procedural applications. The segment was valued at approximately USD 300 million in 2022, with projections indicating compounded annual growth rates (CAGR) of around 5-6% over the next five years [1].

Urovist’s niche positioning as a dedicated urinary tract contrast agent positions it uniquely within the broader contrast media market, which includes agents for angiography, computed tomography (CT), magnetic resonance imaging (MRI), and fluoroscopy. The adoption of Urovist Meglumine Diu/CT is concentrated in hospital settings and specialized imaging centers, with increasing interest from physiologists and urologists seeking more precise visualization tools.


Market Drivers

1. Rising Incidence of Urological Conditions

The prevalence of urinary tract infections, kidney stones, bladder cancers, and other urological conditions is climbing globally, especially in aging populations [2]. This trend fuels demand for diagnostic imaging, consequently expanding the market for contrast agents like Urovist Meglumine Diu/CT.

2. Technological Advancements in Imaging

Integrating ultrasound, CT, and fluoroscopy advances, alongside improved contrast agent formulations, enhances image clarity, safety, and patient comfort. Urovist benefits from these innovations, driving its adoption in complex diagnostic procedures.

3. Increased Adoption of Minimally Invasive Procedures

The shift toward minimally invasive urological surgeries and diagnostics fosters demand for high-quality contrast agents. Urovist Meglumine Diu/CT, with its safety profile and imaging efficacy, aligns well with this trend.

4. Regulatory Approvals and Market Penetration

Regulatory clearances (e.g., FDA approval for specific indications) in key regions bolster market confidence and facilitate broader adoption. Companies strategically expanding their distribution channels further accelerate market growth.


Challenges Impacting Market Dynamics

1. Competition from Alternative Contrast Agents

Other contrast media, such as iohexol, iodixanol, and non-iodinated agents, present competitive threats, offering similar or improved imaging quality, sometimes with lower costs or fewer side effects [3].

2. Safety and Adverse Effect Concerns

The potential for allergic reactions, nephrotoxicity, and other adverse events can limit the use of ionic contrast agents like meglumine diatrizoate, especially among at-risk patient groups. This challenge necessitates vigilance in usage and impacts market expansion.

3. Regulatory and Reimbursement Policies

Variations in reimbursement frameworks across regions influence the volume of contrast media utilization. Complex regulatory pathways may delay market entry of new formulations or prevent certain regions from adopting Urovist extensively.

4. Supply Chain and Manufacturing Constraints

Global supply chain disruptions, raw material shortages, and manufacturing capacity limitations can impede consistent product availability, affecting sales and growth trajectories.


Financial Trajectory and Market Outlook

Revenue Projections and Growth Potential

Based on current market data, Urovist Meglumine Diu/CT is poised for continued, moderate growth. The CAGR of around 5-6% over the next five years reflects increasing procedural volumes and expanding indications. Total sales are projected to approach USD 400-450 million globally by 2027 [1].

Regional Market Dynamics

  • North America: Dominates due to high procedural volumes, advanced healthcare infrastructure, and favorable reimbursement policies. The U.S. market alone represents approximately 40% of sales influenced by routine imaging and regulatory approvals.
  • Europe: Significant growth driven by increasing urological conditions and reimbursement schemes, with notable uptake in Germany, France, and the UK.
  • Asia-Pacific: Exhibits the fastest growth rate (CAGR 7-8%), fueled by expanding healthcare access, economic development, and higher incidences of urinary disorders.

Pricing and Market Penetration

Pricing strategies are influenced by competition, regulatory stipulations, and hospital procurement practices. As generic competition expands, prices tend to decline, which could compress margins but increase overall volume. Innovative formulations and combination therapies may offer premium pricing opportunities.

Emerging Trends Influencing the Financial Pathway

  • Personalized Imaging Protocols: Customizing contrast doses based on patient-specific factors enhances safety and efficacy, potentially attracting premium reimbursement.
  • Integration with Digital Health Technologies: Use of AI-enabled image analysis improves diagnostic accuracy, further elevating the value proposition of contrast agents.
  • Regulatory Accelerations: Fast-track approvals in certain regions could spur rapid adoption, notably in emerging markets.

Consolidation and Future Opportunities

The market landscape is moderately consolidated, with major pharmaceutical companies, such as Guerbet and Bayer, holding significant market shares. Strategic mergers and acquisitions, licensing arrangements, and joint ventures could reshape market dynamics, unlocking growth avenues.

Advancements in nanoparticle-based contrast agents and non-iodinated alternatives represent future areas of innovation. Should these technologies prove safe and cost-effective, they could challenge the current positioning of Urovist Meglumine Diu/CT.


Conclusion

Urovist Meglumine Diu/CT’s market growth hinges on the expanding global burden of urological diseases, technological innovations, and evolving clinical practices. Its financial trajectory is optimistic but requires navigation of competitive, regulatory, and safety landscape challenges. The product’s sustained success will depend on strategic positioning, continuous innovation, and adaptation to regional market nuances.


Key Takeaways

  • The global urological contrast agent market is projected to grow at a 5-6% CAGR through 2027, driven by rising urinary tract disorder prevalence.
  • Urovist Meglumine Diu/CT benefits from technological advances and the shift toward minimally invasive diagnostics but faces competition from non-iodinated and alternative contrast media.
  • Geographic hotspots for growth include North America and Asia-Pacific, with regulatory approvals and reimbursement policies playing crucial roles.
  • Price competition and safety concerns necessitate innovation and marketing strategies optimized for regional settings.
  • Future prospects may involve integrating digital health technologies and exploring novel contrast formulations to sustain growth.

FAQs

Q1: How does Urovist Meglumine Diu/CT compare to other urological contrast agents?
A: It offers high-quality visualization and favorable safety profiles within its niche, but competition from non-ionic, non-iodinated agents with fewer side effects persists. Choice depends on procedural requirements, patient risk factors, and regional preferences.

Q2: What regulatory hurdles could impact Urovist’s market expansion?
A: Variations in approvals across regions, delays in obtaining clearance, and differing reimbursement policies can impede rapid market penetration, particularly in emerging markets.

Q3: How are safety concerns affecting Urovist Meglumine Diu/CT adoption?
A: Allergic reactions and nephrotoxicity risks lead to cautious use, especially in vulnerable populations. Enhanced safety profiles with newer agents could influence future demand.

Q4: What technological trends favor the growth of contrast agents like Urovist?
A: Integration of AI in imaging, personalized dosing protocols, and digital connectivity improve diagnostic accuracy, fostering increased demand.

Q5: What strategies could pharmaceutical companies adopt to maximize Urovist’s market potential?
A: Focus on regional regulatory approvals, expand indications, invest in safety and efficacy research, and adopt digital health collaborations to meet evolving clinical needs.


References

[1] Market Research Future, "Global Contrast Media Market Size & Share Analysis," 2022.
[2] Globocan 2020, "Cancer Statistics," International Agency for Research on Cancer.
[3] Johnson & Johnson, "Contrast Media Overview," 2021.

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