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Last Updated: December 16, 2025

ULTRAVIST 370 Drug Patent Profile


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Which patents cover Ultravist 370, and when can generic versions of Ultravist 370 launch?

Ultravist 370 is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in ULTRAVIST 370 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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Drug patent expirations by year for ULTRAVIST 370
Recent Clinical Trials for ULTRAVIST 370

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

SponsorPhase
Guerbet/Liebel-FlarsheimPhase 4
Duke Clinical Research InstitutePhase 4
GE HealthcarePhase 4

See all ULTRAVIST 370 clinical trials

Pharmacology for ULTRAVIST 370

US Patents and Regulatory Information for ULTRAVIST 370

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 370 iopromide INJECTABLE;INJECTION 020220-001 May 10, 1995 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

International Patents for ULTRAVIST 370

See the table below for patents covering ULTRAVIST 370 around the world.

Country Patent Number Title Estimated Expiration
Denmark 159772 ⤷  Get Started Free
Germany 3060434 ⤷  Get Started Free
Germany 2909439 ⤷  Get Started Free
Denmark 91880 ⤷  Get Started Free
Czechoslovakia 226408 METHOD OF PREPARING TRIIODINATED DIAMIDES OF ISOPHTALIC ACID ⤷  Get Started Free
Japan S6341898 ⤷  Get Started Free
Australia 529565 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for ULTRAVIST 370

Last updated: August 1, 2025

Introduction

ULTRAVIST 370, chemically identified as iothalamate meglumine, is a radiocontrast agent predominantly used in radiology diagnostics. Approved initially by regulatory agencies such as the FDA, ULTRAVIST 370's role in enhancing imaging clarity has cemented its place in medical procedures. As with many established pharmaceuticals, understanding its market dynamics and financial trajectory provides critical insights into investment prospects, manufacturing viability, and competitive positioning within the imaging agent sector.

Market Landscape and Demand Drivers

Prevalence of Imaging Procedures

The primary demand for ULTRAVIST 370 stems from its application in diagnostic imaging modalities: computed tomography (CT), angiography, and fluoroscopy. The rising global burden of chronic diseases—cardiovascular, oncologic, neurological—has led to increased reliance on advanced imaging, thereby boosting demand for contrast agents [1].

Technological Advancements

Innovations in imaging techniques, including high-resolution CT scans, necessitate high-quality contrast agents. ULTRAVIST 370's high iodine concentration ensures superior tissue differentiation. As the industry shifts towards digital and minimally invasive procedures, demand for reliable contrast media remains robust.

Regulatory and Safety Profile

ULTRAVIST 370's extensive clinical use has yielded a well-documented safety profile, although concerns such as nephrotoxicity in at-risk populations influence prescribing patterns. Regulatory actions or labeling modifications can impact market share, emphasizing the importance of ongoing post-market surveillance.

Competitive Dynamics

Amidst a consolidating market, ULTRAVIST 370 faces competition from other iodinated contrast media (ICMs) like iohexol, iopamidol, and newer non-iodinated agents. Companies investing in developing alternative contrast agents—such as gadolinium-based or nanoparticle-based options—could reshape the landscape.

Emerging Markets

Regions such as Asia-Pacific exhibit exponential growth in medical imaging adoption due to increasing healthcare expenditure and expanding infrastructure. These markets represent significant growth opportunities, though price sensitivity and regulatory variability pose challenges.

Market Size and Financial Trajectory

Historical Financial Performance

While proprietary financial data on ULTRAVIST 370 is scarce due to its positioning as a legacy product, available market reports suggest steady revenue streams driven by longstanding clinical necessity. The global contrast media market was valued at approximately USD 4 billion in 2022, with iodinated contrast agents accounting for a substantial proportion.

Projected Market Growth

Forecasts anticipate a compound annual growth rate (CAGR) of around 4–6% over the next five years, primarily driven by rising imaging procedures and expanding healthcare access in emerging economies [2]. Premium pricing strategies, especially in developed markets with stringent reimbursement policies, sustain profit margins.

Patent and Generic Competition

ULTRAVIST 370 is off-patent, making the market highly commoditized. Entry of generic manufacturers has led to pricing pressures, eroding profit margins. However, manufacturer agreements with healthcare providers and supply chain efficiencies can buffer declines in revenue.

Impact of Regulatory Changes

Stringent safety and environmental regulations could influence manufacturing costs or restrict usage in vulnerable populations. Initiatives to develop non-iodinated or lower-risk contrast agents may curtail long-term growth, necessitating diversification strategies.

Pricing Trends and Reimbursement

Pricing strategies depend heavily on regional reimbursement policies. In the U.S., Medicare and private insurers' reimbursement structures influence providers' choices of contrast agents. Cost containment pressures may favor generic suppliers, impacting ULTRAVIST 370’s financial trajectory.

Supply Chain and Manufacturing Considerations

Raw Material Availability

Iodine supply, a critical raw material, faces geopolitical and environmental risks. Fluctuations in iodine prices directly impact production costs for ULTRAVIST 370.

Manufacturing Complexity

Stable manufacturing processes are essential given the sterile, high-purity requirements for injectable contrast agents. Scaling production during surges in demand or addressing environmental regulations involves substantial capital investment.

Distribution Channels

Global distribution networks, regulated by national agencies, influence market penetration. Partnerships with healthcare distributors and adherence to quality standards are pivotal.

Technological and Market Innovations

Development of Safer Contrast Agents

Research into lower nephrotoxicity, biocompatibility, and environmental impact could lead to replacements for existing iodinated contrast media, challenging ULTRAVIST 370’s market dominance.

Emergence of Digital and AI Imaging

Enhanced imaging software integrates with contrast media to improve diagnostic accuracy. Products that align with these technological trends, such as agents optimized for advanced imaging techniques, could secure higher market share.

Alternative Imaging Modalities

Development of non-contrast imaging modalities or the increased use of MRI (which employs gadolinium-based agents) may gradually reduce reliance on iodinated contrast media, influencing long-term demand.

Regulatory and Environmental Challenges

Environmental Impact

Disposal of contrast media residues poses ecological concerns, prompting regulatory scrutiny. Stricter disposal regulations may influence manufacturing processes and costs.

Patient Safety Concerns

Adverse events such as allergic reactions or contrast-induced nephropathy (CIN) impact clinical decisions and can affect the product's reputation and usage volume, directly influencing revenue streams.

Strategic Outlook

The outlook for ULTRAVIST 370 hinges on the global healthcare landscape’s evolution and pharmaceutical manufacturers' ability to adapt. Continuous improvement in safety profiles, cost management, and strategic positioning in emerging markets will be crucial. Additionally, innovation investments in new contrast media technologies could redefine the competitive backdrop.

Key Takeaways

  • Stable but mature market: ULTRAVIST 370's sales are relatively stable, supported by ongoing demand in diagnostic imaging but face erosion due to generic competition and regulatory pressures.

  • Growth driven by imaging demand: The expanding global need for advanced diagnostic procedures sustains demand, particularly in emerging markets with increasing healthcare investments.

  • Pricing pressures and generics: The off-patent status intensifies price competition, requiring manufacturers to optimize supply chains and explore value-added services.

  • Innovation as a safeguard: Future growth depends on developing safer, environmentally friendly contrast agents and integrating with innovative imaging technologies.

  • Regulatory environment: Stringent safety and environmental regulations will shape manufacturing and distribution strategies, influencing long-term profitability.

FAQs

  1. What are the primary factors influencing ULTRAVIST 370’s market demand?
    Demand primarily correlates with the volume of diagnostic imaging procedures, technological advancements in imaging, and regional healthcare expenditure. Increasing use of high-resolution CT scans sustains consistent demand, while safety concerns and regulatory policies influence prescribing patterns.

  2. How does the patent status of ULTRAVIST 370 impact its market?
    Being off-patent, ULTRAVIST 370 faces intense price competition from generic manufacturers, which can erode margins. This commoditization emphasizes cost efficiencies and emphasizes differentiating factors like reputation and supply reliability.

  3. What challenges could hinder ULTRAVIST 370’s financial growth?
    Key risks include regulatory restrictions due to safety or environmental concerns, substitution by newer contrast agents or alternative imaging modalities, and declining usage in favor of non-iodinated options or MRI-based diagnostics.

  4. Are emerging markets an opportunity for ULTRAVIST 370?**
    Yes. Rapidly expanding healthcare infrastructure and increasing adoption of diagnostic imaging make emerging markets significant growth opportunities. However, price sensitivity and regulatory hurdles necessitate tailored strategies.

  5. What are future prospects for innovation within the iodinated contrast agent market?
    Potential innovations include developing lower nephrotoxicity formulations, biodegradable agents, and environmentally sustainable manufacturing processes. These advancements could mitigate safety and ecological concerns and maintain competitiveness.

References

[1] Grand View Research. "Contrast Media Market Size & Share," 2022.

[2] MarketsandMarkets. "Contrast Media Market," 2023.

(Note: Citations are representative; specific sources should be referenced in detailed industry reports.)

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