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Last Updated: December 15, 2025

ULTRAVIST (PHARMACY BULK) Drug Patent Profile


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Which patents cover Ultravist (pharmacy Bulk), and when can generic versions of Ultravist (pharmacy Bulk) launch?

Ultravist (pharmacy Bulk) is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in ULTRAVIST (PHARMACY BULK) 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 (PHARMACY BULK)
Drug patent expirations by year for ULTRAVIST (PHARMACY BULK)
Recent Clinical Trials for ULTRAVIST (PHARMACY BULK)

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

See all ULTRAVIST (PHARMACY BULK) clinical trials

US Patents and Regulatory Information for ULTRAVIST (PHARMACY BULK)

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 (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-003 Mar 12, 2004 DISCN Yes No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-001 Sep 20, 2002 RX Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-002 Sep 20, 2002 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

Expired US Patents for ULTRAVIST (PHARMACY BULK)

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-003 Mar 12, 2004 ⤷  Get Started Free ⤷  Get Started Free
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-002 Sep 20, 2002 ⤷  Get Started Free ⤷  Get Started Free
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-001 Sep 20, 2002 ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for ULTRAVIST (PHARMACY BULK)

See the table below for patents covering ULTRAVIST (PHARMACY BULK) around the world.

Country Patent Number Title Estimated Expiration
Spain 491254 ⤷  Get Started Free
Israel 59542 ISOPHTHALIC ACID DIAMIDE DERIVATIVES,NON-IONIC X-RAY CONTRAST PREPARATIONS CONTAINING THE SAME AND PROCESS FOR THE PREPARATION THEREOF ⤷  Get Started Free
Egypt 14530 NON-IONIC X-RAY CONTRAST AGENTS ⤷  Get Started Free
Japan S55153755 TRIIODOISOPHTHALIC ACID DIAMIDE DERIVATIVE* ITS MANUFACTURE AND X RAY CONTRAST AGENT CONTAINING IT ⤷  Get Started Free
Denmark 159772 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for ULTRAVIST (PHARMACY BULK)

Last updated: July 30, 2025

Introduction

Ultravist (generic: iodinated contrast media, pharmacy bulk) is a widely used contrast agent primarily employed in diagnostic imaging procedures such as computed tomography (CT) scans. Its pharmacological efficacy in enhancing imaging clarity has established a significant foothold across hospitals and imaging centers worldwide. As a pharmacy bulk formulation, Ultravist offers flexible dosing options, rendering it popular among radiology departments. Understanding its market dynamics and financial trajectory involves analyzing regulatory factors, market demand, competitive landscape, technological advancements, and global health trends.


Market Overview

The global contrast media market, which includes Ultravist, is projected to grow at a compounded annual growth rate (CAGR) of approximately 4.5% between 2022 and 2027, driven by increasing prevalence of chronic diseases requiring advanced imaging diagnostics. The rising adoption of minimally invasive procedures and rising healthcare expenditure in emerging economies further bolster this growth trajectory[1].

Ultravist, produced by Bayer AG, holds a significant share of the iodinated contrast agents segment. Its reputation for superior image enhancement and safety profile positions it favorably in both mature and developing markets. The pharmacy bulk formulation of Ultravist offers cost efficiencies, reducing waste and optimizing inventory management for healthcare providers.


Market Dynamics

Regulatory Environment

Stringent regulatory frameworks impact Ultravist’s market access. The approval processes by agencies like the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) shape product positioning and market entry strategies. Bayer’s compliance with these regulatory standards bolsters confidence among healthcare providers. Ongoing post-marketing surveillance and safety reporting influence the market, especially given concerns over adverse reactions associated with iodinated contrast media, such as allergic responses and nephrotoxicity[2].

Competitive Landscape

Ultravist competes with other iodinated contrast agents such as Visipaque (iodixanol), Omnipaque (iohexol), and generic formulations. While patented formulations like Visipaque have gained favor for their iso-osmolar properties reducing risks of adverse events, Ultravist maintains competitive pricing and widespread availability. The pharmacy bulk format enables hospitals to negotiate favorable contracts and streamline procurement, sustaining its market share.

Technological and Clinical Trends

Advancements in imaging technology, including the development of lower-osmolar and iso-osmolar contrast agents, are altering market preferences. While Ultravist, as a low-osmolar contrast media, remains relevant, there is a gradual shift towards agents with improved safety profiles. Additionally, the integration of imaging modalities with artificial intelligence and other diagnostics influences the volume and types of contrast media required.

Geographical Market Dynamics

North America dominates the contrast media market owing to high healthcare expenditure, advanced medical infrastructure, and regulatory approvals. The Asia-Pacific region presents substantial growth potential, fueled by rising healthcare investments, increased diagnostics, and expanding private healthcare sectors[3]. Emerging markets are particularly attractive due to the expansion of imaging services.

Supply Chain Considerations

Supply chain robustness influences Ultravist’s market stability. Bayer's manufacturing capabilities and distribution networks are critical to meeting global demand, especially in the wake of disruptions caused by the COVID-19 pandemic. The pharmaceutical company's strategic inventory management of pharmacy bulk formulations allows for efficient distribution and cost control.


Financial Trajectory

Revenue Trends

Historically, Ultravist has been a profitable product segment for Bayer, driven by consistent demand in healthcare facilities. The company reports that contrast media sales comprise a significant portion of its radiology segment revenue, which, while facing compression from generic competition and price pressures, remains resilient due to its established clinical efficacy and safety profile.

Pricing Dynamics

Pricing strategies are influenced by market competition, procurement negotiations, and regulatory pricing controls. Pharmacy bulk formulations afford hospitals the opportunity for volume-based discounts, maintaining Ultravist’s competitiveness. Additionally, generic manufacturers entering the iodinated contrast media sector exert downward pressure on prices, potentially impacting profit margins.

Research and Development Impact

Bayer invests in refining contrast media formulations to enhance safety, reduce adverse reactions, and improve imaging outcomes. These innovations sustain Ultravist’s relevance, though significant shifts toward alternative imaging techniques like MRI, which do not require contrast agents, may temper long-term growth prospects.

Market Penetration and Growth Opportunities

Expanding into emerging markets presents a lucrative avenue for revenue growth. Bayer’s strategic partnerships with regional distributors, coupled with localized regulatory approvals, underpin this approach. Moreover, increasing adoption of ultrasound and MRI that utilize differing or no contrast agents diversifies the market, but iodinated contrast remains essential in many diagnostic indications, ensuring continued demand.


Impact of Global Health Trends

The COVID-19 pandemic underscored the importance of imaging in diagnosing and managing infectious diseases. The pandemic temporarily disrupted elective imaging procedures, causing short-term revenue fluctuations. Nonetheless, the normalization of healthcare activity, along with increased screening for chronic conditions such as cancer, sustains a robust demand trajectory for contrast media, including Ultravist.

Similarly, an aging global population elevates the incidence of cardiovascular and cerebrovascular diseases—key indications for contrast-enhanced imaging—favoring steady demand growth.


Regulatory and Safety Considerations

While Ultravist enjoys regulatory approval in major markets, safety concerns surrounding iodinated contrast media—particularly in patients with impaired renal function—have prompted clinicians to seek alternative imaging modalities or contrast agents with improved safety profiles. Bayer’s ongoing pharmacovigilance efforts aim to mitigate risks and maintain market confidence.

Emerging regulations advocating for environmentally friendly manufacturing processes and disposal practices also influence production costs and market competitiveness.


Competitive and Market Challenges

The primary challenges include increasing competition from generic manufacturers, evolving safety standards, and technological shifts toward non-contrast imaging techniques. The potential development of contrast agents with reduced nephrotoxicity and allergic reactions could pressure Ultravist’s market position. Furthermore, reimbursement policies and healthcare cost containment initiatives influence purchasing decisions globally.


Future Outlook

The financial trajectory of Ultravist hinges on several key factors:

  • Market Penetration: Continued expansion into emerging markets will drive volume growth.
  • Innovation: Bayer’s R&D efforts aimed at improving safety and efficacy will help retain market share.
  • Segment Evolution: Increasing adoption of alternative imaging modalities may slightly diminish future demand; however, contrast media remain integral in complex diagnostic procedures.
  • Regulatory Landscape: Navigating evolving safety regulations and acquiring approval for new formulations will be pivotal.
  • Competitive Positioning: Leveraging pharmacy bulk formulations for cost advantages remains a strong market differentiator.

Overall, Ultravist’s financial outlook remains cautiously optimistic. Its established clinical utility and strategic positioning in pharmacy bulk formulations underpin its ongoing profitability, although market maturation and technological advancements necessitate adaptive strategies.


Key Takeaways

  • Stable Demand Roots: Ultravist benefits from continued high demand for iodinated contrast media in CT and angiography procedures globally.
  • Growth in Emerging Markets: Expanding penetration and infrastructure development in the Asia-Pacific and Latin America present significant revenue opportunities.
  • Competitive Pressures: Price competition from generics and innovation in contrast agent formulations compel Bayer to prioritize safety improvements and cost efficiencies.
  • Technological Shifts: The trend toward non-contrast imaging and alternative modalities may limit the long-term growth of iodinated contrast agents but will not eliminate their utility in complex diagnostics.
  • Regulatory and Safety Focus: Ongoing compliance and safety improvements are crucial to maintaining market access and customer trust.

FAQs

1. How does Ultravist compare to alternatives like Visipaque or Omnipaque?
Ultravist is a low-osmolar iodinated contrast agent offering effective imaging enhancement. Visipaque, as an iso-osmolar agent, is preferred in patients at higher risk for adverse effects, while Omnipaque provides comparable efficacy. Price, safety profile, and specific patient considerations determine choice among these agents.

2. What role does pharmacy bulk formulation play in Ultravist’s market strategy?
Pharmacy bulk formulations allow hospitals to buy in larger quantities, reducing costs and waste, and enabling customized dosing. This approach boosts Bayer’s market penetration efficiency, especially in high-volume radiology departments.

3. Are there any new developments or formulations of Ultravist in pipeline?
Bayer invests in enhancing contrast media safety and efficacy through ongoing R&D. While no specific new formulations of Ultravist are publicly announced, innovations focus on minimizing adverse reactions and environmental impact.

4. What safety concerns are associated with Ultravist?
Adverse reactions, including allergic responses and contrast-induced nephropathy, are concerns, especially in patients with compromised renal function. Regulatory efforts aim to mitigate these risks via labeling, safety guidelines, and alternative diagnostic methods.

5. How will global health trends affect Ultravist’s future market?
Aging populations and increased prevalence of chronic diseases support steady demand. Conversely, technological shifts toward non-contrast imaging may moderate long-term growth, emphasizing the need for continuous innovation.


Sources:

[1] MarketsandMarkets, "Contrast Media Market by Type," 2022.
[2] FDA Drug Safety Communications, "Risks Associated with Iodinated Contrast Agents," 2021.
[3] Grand View Research, "Contrast Media Market Insights," 2022.

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