Iopromide - Generic Drug Details

What are the generic sources for iopromide and what is the scope of patent protection?

Iopromide is the generic ingredient in six branded drugs marketed by Bayer Hlthcare and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for iopromide. One supplier is listed for this compound.

Summary for iopromide

US Patents:	0
Tradenames:	6
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	86
Clinical Trials:	13
What excipients (inactive ingredients) are in iopromide?	iopromide excipients list
DailyMed Link:	iopromide at DailyMed

Recent Clinical Trials for iopromide

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

Sponsor	Phase
University of Sao Paulo General Hospital	PHASE4
Guerbet/Liebel-Flarsheim	Phase 4
Duke Clinical Research Institute	Phase 4

See all iopromide clinical trials

Pharmacology for iopromide

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

Anatomical Therapeutic Chemical (ATC) Classes for iopromide

V08AB	Watersoluble, nephrotropic, low osmolar X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for iopromide

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
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST 300 IN PLASTIC CONTAINER	iopromide	INJECTABLE;INJECTION	020220-005	Nov 18, 2008		DISCN	Yes	No
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-002	Sep 20, 2002		RX	Yes	Yes

Expired US Patents for iopromide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ULTRAVIST 240	iopromide	INJECTABLE;INJECTION	020220-003	May 10, 1995
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-003	Mar 12, 2004
Bayer Hlthcare	ULTRAVIST 370	iopromide	INJECTABLE;INJECTION	020220-001	May 10, 1995
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995

Market Dynamics and Financial Trajectory for Iopromide

Last updated: July 27, 2025

Introduction

Iopromide is a contrast agent widely used in diagnostic imaging, particularly in computed tomography (CT) scans. As a non-ionic, low-osmolar iodine-based contrast medium, it plays a vital role in enhancing diagnostic accuracy. Its market has experienced significant growth influenced by technological advancements in imaging, expanding healthcare infrastructure, and increasing prevalence of chronic and acute diseases requiring imaging procedures. This article explores the current market dynamics, growth factors, competitive landscape, regulatory influences, and financial outlook pertinent to iopromide.

Market Overview and Segmentation

The global contrast agents market, where iopromide is a key product, is projected to grow at a compound annual growth rate (CAGR) of approximately 5–7% over the next five years. The rising demand for advanced diagnostic tools and minimally invasive procedures drives this expansion. Iopromide predominantly competes within the class of iodine-based contrast agents, which account for a significant share of the overall market.

Segmentation can be categorized by application (CT imaging, angiography, neuroimaging), end-user (hospitals, imaging centers, outpatient clinics), and geography. The CT imaging segment constitutes the largest application area for iopromide, owing to its superior safety profile and diagnostic efficacy compared to older ionic contrasts.

Market Drivers

Growing Adoption of Diagnostic Imaging

The increasing utilization of CT scans globally fuels demand for contrast agents like iopromide. This trend is driven by technological innovations, such as high-resolution scanners, which enable more precise and earlier detection of diseases.

Prevalence of Chronic Diseases and Aging Population

Rising incidences of cardiovascular diseases, cancer, and neurological disorders necessitate frequent imaging, thereby expanding the market for contrast media. An aging population, especially in North America and Europe, amplifies this demand, as seniors are more susceptible to such conditions.

Technological Innovations and Product Developments

Development of low-osmolar and iso-osmolar contrast agents like iopromide has enhanced patient safety, increasing clinical acceptance and usage. Continuous R&D efforts by pharmaceutical firms have led to improved formulations with reduced adverse effects, broadening their application scope.

Expanding Healthcare Infrastructure in Emerging Markets

Emerging economies such as China, India, and Brazil are investing heavily in healthcare infrastructure, including imaging equipment. This expansion contributes to rising contrast media consumption, positioning iopromide as a preferred choice due to its safety profile.

Regulatory Approvals and Reimbursement Policies

Regulatory agencies like the FDA and EMA have approved iopromide for multiple indications, facilitating market penetration. Reimbursement policies that cover diagnostic procedures using contrast agents further boost sales.

Market Constraints and Challenges

Safety and Adverse Effects

While iopromide is generally well tolerated, risks related to contrast-induced nephropathy (CIN) and allergic reactions can hinder broader adoption, particularly among high-risk patient groups. Managing these risks demands careful patient selection and screening.

Regulatory Challenges

Variability in approval processes and reimbursement policies across regions can limit market performance. Additionally, the emergence of new, more effective contrast agents could threaten iopromide’s market share.

Cost Pressures and Healthcare Spending

Cost containment efforts and healthcare austerity measures, especially in developed countries, pressure prices and limit growth prospects for high-cost contrast media.

Competition from Alternative Imaging Modalities

The advent of non-contrast imaging techniques and familiarity with MRI and ultrasound, which do not require contrast media, pose long-term competition.

Competitive Landscape

Major players manufacturing iopromide include Bayer AG, Guerbert, and other regional biotech firms. Bayer's Omnipaque is a leading brand, signifying its dominant market position. Key competitive strategies involve product innovation, expanding regional presence, and partnerships with healthcare providers.

Product Innovations

Developments in formulations that reduce side effects and improve imaging quality bolster market presence. Iopromide's safety advancements have solidified its standing in the contrast media segment.

Strategic Alliances and Partnerships

Collaborations with hospital chains and imaging centers facilitate clinic adoption and increase sales volume. Licensing agreements and regional expansions are also prevalent strategies.

Financial Trajectory and Market Forecast

Revenue Projections

The anticipated compound annual growth rate for iopromide and similar contrast agents is approximately 5–7%. Revenues are expected to increase commensurately, driven by rising imaging procedures globally.

Pricing Trends

Pricing is under continual pressure due to market competition and healthcare cost-saving measures. Despite this, premium formulations offering enhanced safety profiles command higher prices and margins.

Profitability Outlook

Established brands like Bayer’s Omnipaque maintain healthy profit margins due to high market share and brand recognition. Sales growth in emerging markets is likely to improve profitability, subject to regulatory and reimbursement landscape adjustments.

Investment and R&D Outlook

Investments in next-generation contrast agents with improved safety and specificity are poised to influence future market dynamics. R&D is likely to focus on reducing side effects and expanding indications, which could drive incremental revenue streams.

Regulatory Environment and Its Impact

Global regulatory frameworks are pivotal in shaping market access. The FDA and EMA, along with regional bodies, facilitate approvals based on safety and efficacy data. Stringent regulations can delay product launches or impose additional costs but also assure quality and safety, fostering consumer confidence.

Bayer and other manufacturers continuously engage with regulators to ensure compliance and facilitate market expansion, especially in emerging regions where regulatory frameworks are evolving.

Conclusion

The market for iopromide remains robust owing to the expanding demand for diagnostic imaging and technological innovation. While challenges such as safety concerns, regulatory hurdles, and cost pressures exist, strategic product development and geographic expansion offer significant growth opportunities. The industry’s trajectory points toward increased sales, driven by rising healthcare spending, aging populations, and ongoing technological advances.

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Key Takeaways

• The global contrast media market is expected to grow at 5–7% CAGR, with iopromide maintaining a significant share.
• Growing adoption of CT imaging, especially in aging populations and emerging markets, underpins demand.
• Product safety improvements and technological advancements bolster market confidence.
• Competitive advantages hinge on innovation, strategic collaborations, and regional expansion.
• Regulatory dynamics significantly influence market access, pricing, and growth prospects.

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FAQs

1. How does iopromide differentiate from other contrast agents?
Iopromide is an iso-osmolar, non-ionic iodine-based contrast agent offering a high safety profile, lower risk of adverse reactions, and effective imaging enhancement, making it preferable over older ionic or high-osmolar contrasts.

2. What are the primary factors influencing the market growth of iopromide?
Key factors include the rising prevalence of chronic diseases, technological advances in imaging, expanding healthcare infrastructure, regulatory approvals, and increasing adoption in emerging markets.

3. What are the safety concerns associated with iopromide?
While generally safe, risks include contrast-induced nephropathy and allergic reactions. Patient screening and premedication protocols are employed to mitigate these risks.

4. How might regulatory challenges impact iopromide’s market?
Variable regional regulations can delay approvals, increase compliance costs, or restrict usage, impacting sales growth and market expansion.

5. What strategic moves could enhance the market position of manufacturers like Bayer?
Product innovation, geographic diversification, strategic partnerships, and proactive regulatory engagement are critical strategies for strengthening market share and ensuring long-term profitability.

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Sources:

[1] Market Research Future, "Contrast Media Market," 2022.
[2] Grand View Research, "Contrast Agents Market Size, Share & Trends," 2023.
[3] Bayer AG Annual Reports, 2022.