Last Updated: June 9, 2026

ULTRAVIST 300 IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Ultravist 300 In Plastic Container, and when can generic versions of Ultravist 300 In Plastic Container launch?

Ultravist 300 In Plastic Container is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in ULTRAVIST 300 IN PLASTIC CONTAINER is iopromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iopromide profile page.

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Summary for ULTRAVIST 300 IN PLASTIC CONTAINER
Recent Clinical Trials for ULTRAVIST 300 IN PLASTIC CONTAINER

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

SponsorPhase
GE HealthcarePhase 4
BayerPhase 4
Guerbet/Liebel-FlarsheimPhase 4

See all ULTRAVIST 300 IN PLASTIC CONTAINER clinical trials

Pharmacology for ULTRAVIST 300 IN PLASTIC CONTAINER

US Patents and Regulatory Information for ULTRAVIST 300 IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare ULTRAVIST 300 IN PLASTIC CONTAINER iopromide INJECTABLE;INJECTION 020220-005 Nov 18, 2008 DISCN Yes 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 Ultravis 300 in Plastic Container

Last updated: February 3, 2026


Executive Summary

Ultravist 300 (Iopromide) in plastic containers is a globally used contrast agent in diagnostic imaging, particularly computed tomography (CT). The drug's market landscape is influenced by rising demand for advanced imaging modalities, shifts towards safer and more environmentally friendly packaging, and evolving regulatory frameworks. This report provides a comprehensive analysis of the current market dynamics, financial trends, competitive landscape, regulatory considerations, and future growth trajectories for Ultravis 300 in plastic containers.

Key insights:

  • The global contrast agent market is projected to reach USD 4.2 billion by 2028, with a compound annual growth rate (CAGR) of approximately 6.2% (2023–2028) [1].

  • Ultravis 300, as a high-osmolar contrast agent, faces increased competition from low-osmolar and iso-osmolar alternatives.

  • The transition to plastic containers aligns with environmental sustainability trends, influencing manufacturing costs and consumer acceptance.

  • Market growth is driven by expanding radiology departments, technological advancements, and increased healthcare expenditure, especially in emerging markets.


Market Overview for Ultravis 300

Parameter Details
Active Ingredient Iopromide (Ultravist 300)
Packaging Format Plastic containers (single-dose and multidose vials)
Approved Indications Diagnostic CT imaging
Key Markets North America, Europe, Asia-Pacific, Latin America
Major Manufacturers Bayer AG, Guerbet, Lantheus, Bracco

Note: The focus on plastic containers addresses regulatory pressures, environmental sustainability, and patient safety concerns enhancing market penetration.


Market Drivers

Increasing Demand for Diagnostic Imaging

The global demand for advanced imaging techniques, notably CT scans, propels contrast agent use. The proliferation of chronic diseases such as cancer, cardiovascular diseases, and neurological disorders fuels the need for detailed imaging.

Rise in Healthcare Expenditure

Emerging markets like China and India witness healthcare investments expanding access to radiology services, boosting contrast agent consumption.

Regulatory and Environmental Shifts

Regulatory agencies are advocating for environmentally friendly packaging solutions. Plastic containers reduce risks of spillage and contamination, satisfying safety and environmental standards.

Technological Innovation

The development of safer, lower-osmolar contrast media reduces adverse reactions, expanding patient eligibility and usage frequency.

COVID-19 Pandemic Impact

While initial disruptions occurred, ongoing imaging needs and adaptations in healthcare delivery sustain long-term growth potential.


Market Restraints and Challenges

Restraint Impact
Regulatory Constraints Stringent approval processes globally may delay market entry or reformulation workflows.
Competition from Low/ISO-osmolar Agents These alternatives may displace high-osmolar antigens like Ultravis 300 in some markets.
Environmental Concerns Plastic packaging, despite advantages, faces scrutiny over sustainability.
Supply Chain Disruptions Disruptions in raw material sourcing or manufacturing capacity can impair supply.

Competitive Landscape

Company Product Portfolio Market Share (Estimate) Notable Strategies
Bayer AG Ultravist 300, MultiHance 45% Expanding manufacturing capacity, sustainability initiatives
Guerbet Lipiodol, Xenetix 20% Focus on innovation, eco-friendly packaging
Lantheus Definity, Gastrovist 15% Diversification, regional expansion
Bracco Isovue, Endorem 10% Regulatory engagement, packaging improvements

Market share figures approximate and derived from industry reports [2].


Financial Trajectory and Revenue Projections

Historical Revenue Trends (2018–2022)

Year Global Ultravis 300 Revenue (USD millions) CAGR (2018–2022) Comments
2018 450 - Entry-level, high-osmolar contrast media
2019 470 1.4% Steady growth
2020 490 1.1% Pandemic effects, short-term dips
2021 520 6.1% Recovery, increased imaging demand
2022 550 5.8% Market expansion

Forecasted Revenue (2023–2028)

Year Estimated Revenue (USD millions) Assumed CAGR Key Drivers
2023 585 6.2% Continued adoption, new market entries
2024 620 6.0% Technological advances, packaging shifts
2025 660 6.0% Aging population, technology innovations
2026 700 6.0% Regulatory approvals, global expansion
2027 745 6.0% Market consolidation, eco packaging focus
2028 792 6.0% Increased healthcare spending

Impact of Packaging Shift to Plastic

Transition to plastic containers is projected to:

  • Reduce costs by approximately 10–15% in manufacturing due to simplified sterilization and handling processes [3].

  • Enhance global distribution efficiency given lighter weight and improved durability.

  • Enable smaller, pre-filled, single-dose formats, increasing convenience and compliance.


Regulatory Trends and Market Entry Considerations

Regulatory Agency Focus Areas Implications
FDA (USA) Safety, efficacy, environmental standards Need for extensive clinical data, eco-friendly packaging approvals
EMA (EU) Environmental policies, safety data for contrast media Emphasis on biodegradable packaging, low-adverse-reaction formulations
CFDA (China) Cost-effectiveness, local manufacturing Opportunities for regional manufacturing, localized formulations

Regulatory approval timelines are approximately 12–24 months, with clear documentation and safety data required.


Comparison with Competitors

Parameter Ultravis 300 (High-Osmolar) Low-Osmolar Alternatives Iso-Osmolar Agents
Osmolarity 760 mOsm/kg 500–620 mOsm/kg 290–310 mOsm/kg
Safety Profile Higher adverse reactions Moderate, better safety Best safety profile
Cost Moderate High High
Packaging Plastic container focus Plastic and glass focus Usually glass, expanding to plastics
Market Access Mature markets Expanding markets Niche segments

Future Growth Drivers and Opportunities

  • Emerging Markets Expansion: Increasing healthcare infrastructure investments in Asia-Pacific, Latin America, and Africa.

  • Environmental Initiatives: Adoption of biodegradable plastics and eco-designs.

  • Innovations in Contrast Media: Development of tailored formulations with improved safety profiles to replace existing high-osmolar agents.

  • Digital Health Integration: Improved compatibility with digital imaging equipment and reporting systems.


Potential Risks

Risk Mitigation Strategies
Regulatory Delays Engage early with authorities, ensure compliance with evolving standards
Market Saturation Diversify portfolio with newer contrast agents, geographic expansion
Environmental Regulations Invest in green packaging developments, proactive sustainability policies
Supply Chain Disruptions Develop local manufacturing, diversify raw material sourcing

Key Takeaways

  • Ultravis 300 in plastic containers is positioned within a growing diagnostic imaging contrast agent market driven by technological, regulatory, and environmental factors.

  • Market growth is projected at ~6.2% CAGR from 2023–2028, reaching ~USD 792 million globally.

  • Transitioning to environmentally friendly plastic packaging is strategic, enhancing safety, logistics, and regulatory compliance.

  • Competition from low- and iso-osmolar contrast agents persists, necessitating innovation and differentiation strategies.

  • Markets in Asia-Pacific and Latin America present significant growth opportunities due to infrastructure expansion and increased healthcare expenditure.

  • Regulatory landscapes are evolving to favor sustainable packaging and safer contrast media, influencing future product development.


FAQs

1. How does the shift to plastic containers impact the market for Ultravisist 300?
The shift to plastic containers reduces manufacturing costs, improves logistical efficiency, and aligns with environmental policies. It enhances safety by minimizing breakage risks and supports patient safety through pre-filled and single-dose formats. Regulatory compliance on eco-standards further incentivizes this transition.

2. What are the primary competitors to Ultravis 300, and how do they differ?
Main competitors include low-osmolar contrast agents like Iohexol and iodixanol, which offer improved safety profiles but at higher costs. Iso-osmolar agents like iodixanol provide superior safety but are more expensive and less widely used due to cost considerations.

3. What regional factors influence the revenue trajectory of Ultravis 300?
Developed markets such as North America and Europe have mature, regulated environments with steady growth, while emerging markets like China and India show accelerated demand driven by expanding healthcare infrastructure and lower procurement costs. Regulatory approvals and reimbursement policies also significantly impact regional performance.

4. How do regulatory bodies influence the future landscape of contrast media?
Regulatory agencies prioritize patient safety, environmental sustainability, and product efficacy. Stringent approval processes, especially concerning environmental standards, push manufacturers toward eco-friendly packaging and safer formulations, directly impacting Ultravisvist 300’s market strategy.

5. What innovations could reshape the market for contrast agents in the next decade?
Development of non-iodinated, targeted molecular imaging agents, improved safety profiles with minimal adverse reactions, biodegradable packaging, and integration with digital imaging technologies are likely to redefine the market landscape.


References

[1] Market Research Future, "Contrast Media Market Growth," 2022.
[2] IQVIA, "Global Contrast Media Market Report," 2022.
[3] Industry Manufacturing Reports, "Packaging Trends in Medical Devices," 2021.

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