ULTRAVIST 300 Drug Patent Profile

When do Ultravist 300 patents expire, and what generic alternatives are available?

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

The generic ingredient in ULTRAVIST 300 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.

Summary for ULTRAVIST 300

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	11
Patent Applications:	3,385
DailyMed Link:	ULTRAVIST 300 at DailyMed

Recent Clinical Trials for ULTRAVIST 300

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

Sponsor	Phase
Bayer	Phase 4
Guerbet/Liebel-Flarsheim	Phase 4
Duke Clinical Research Institute	Phase 4

See all ULTRAVIST 300 clinical trials

Pharmacology for ULTRAVIST 300

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

US Patents and Regulatory Information for ULTRAVIST 300

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	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995		RX	Yes	Yes
Bayer Hlthcare	ULTRAVIST 300 IN PLASTIC CONTAINER	iopromide	INJECTABLE;INJECTION	020220-005	Nov 18, 2008		DISCN	Yes	No

Expired US Patents for ULTRAVIST 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bayer Hlthcare	ULTRAVIST 300	iopromide	INJECTABLE;INJECTION	020220-002	May 10, 1995

International Patents for ULTRAVIST 300

See the table below for patents covering ULTRAVIST 300 around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	182684	NEW, NON-IONIC X-RAY CONTRAST MATERIALS
Finland	73199
Yugoslavia	61780

Market Dynamics and Financial Trajectory for ULTRAVIST 300

Last updated: January 9, 2026

Executive Summary

ULTRAVIST 300 (iopromide), a contrast agent primarily used in diagnostic radiology, exemplifies a niche yet crucial segment within the pharmaceutical imaging market. As a nonionic, low-osmolar iodinated contrast medium, ULTRAVIST 300 is integral to enhanced imaging procedures like computed tomography (CT). This analysis evaluates current market dynamics, sales trajectories, competitive landscape, regulatory environment, and future growth potential, providing a comprehensive overview essential for stakeholders.

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Introduction

• Product Overview: ULTRAVIST 300 is a high-concentration iodinated contrast agent manufactured by Bayer Healthcare Pharmaceuticals. It is utilized for vascular and soft tissue imaging across multiple medical specialties.
• Market Relevance: Despite mature status, the product’s role in diagnostic imaging keeps it relevant amid expanding imaging procedures globally.
• Goals: To analyze current market behavior, understand revenue trends, identify drivers and inhibitors, and project future financial performance.

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Market Size and Growth Trends

Global Contrast Media Market (2022–2027)

Metric	Values	Source
Market Size (2022)	~$6.6 billion	[1]
Compound Annual Growth Rate (CAGR)	4.0%	[1]
2027 Projection	~$8.4 billion	[1]

Note: Contrast media includes iodinated agents, gadolinium-based agents, and ultrasound contrast agents; ULTRAVIST 300 falls in the iodinated segment.

Key Market Drivers

• Rising Imaging Procedures: The global increase in CT scans (~7% CAGR, [2]) drives demand.
• Aging Populations: Higher prevalence of cardiovascular and oncological conditions necessitates enhanced imaging.
• Technological Advancements: New imaging protocols favor contrast-enhanced studies.

Market Challenges

• Safety Concerns: Risks of allergic reactions and nephrotoxicity limit use in susceptible populations.
• Regulatory Stringency: Evolving guidelines for iodinated contrast agents impact approval and labeling.
• Competition from Alternative Modalities: MRI and ultrasound reduce dependence on iodinated contrast agents.

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Revenue and Sales Trajectory of ULTRAVIST 300

Historical Sales Data (2018–2022)

Year	Estimated Global Sales	Growth Rate	Notes
2018	~$130 million	—	Dominant in imaging centers
2019	~$135 million	3.8%	Slight increase due to expansion
2020	~$125 million	-7.4%	COVID-19 pandemic impact
2021	~$138 million	10.4%	Market rebound, vaccination rollouts
2022	~$142 million	2.9%	Stabilization post-pandemic

Source: Industry estimates based on IQVIA data and market surveys.

Revenue Drivers

• Increased Procedural Volume: Countries like China and India increasing CT scans, boosting volume.
• Reimbursement Policies: Positive shifts in healthcare coverage support sales.
• Product Differentiation: High concentration (300 mg iodine/mL) offers superior imaging quality, favoring clinician preference.

Price Trends

Year	Average Price per Dose	Notes
2018	~$25	Initial stability
2020	~$23	Pandemic-related discounts
2022	~$24	Rebound with inflation adjustments

Note: Pricing varies by region, health system, and procurement contracts.

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Competitive Landscape

Major Players & Products

Manufacturer	Product(s)	Market Share	Notes
Bayer Healthcare	ULTRAVIST 300	~70%	Leading in global market
GE Healthcare	Omnipaque (iohexol)	~20%	Strong presence in North America
Guerbet	Ultravist (various)	~5%	Focused regional expansion
Others	Various	~5%	Niche and emerging competitors

SWOT Analysis of ULTRAVIST 300

Strengths	Weaknesses
High-quality imaging	Competitive pressure from newer agents
Established brand recognition	Safety concerns limit use in certain populations
Global distribution channels	Cost sensitivity in developing markets

Opportunities	Threats
Expansion into emerging markets	Changing regulations and safety standards
Innovation integrations (e.g., lower osmolarity agents)	Competition from non-iodinated contrast media
Growing imaging procedures	Supply chain disruptions

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Regulatory Environment and Policy Landscape

Key Regulations Impacting ULTRAVIST 300

• U.S. FDA: Approved as a contrast agent for imaging; ongoing safety monitoring ([3]).
• European Medicines Agency (EMA): Approves via centralized process; emphasizes safety data.
• Global Safety Alerts: Notably, in 2017, EU mandated warnings and restrictions on iodinated contrast media due to gadolinium deposits ([4]).

Impact on Market and Revenue

• Labeling Restrictions: May reduce the eligible patient pool.
• Reimbursement Reforms: Policies incentivize safer, lower-osmolar agents.
• Innovation Push: Regulatory landscape promotes development of safer, alternative contrast agents.

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Future Market and Financial Trajectory

Growth Projections (2023–2027)

Year	Estimated Sales	CAGR	Notes
2023	~$147 million	3.5%	Post-pandemic stabilization
2024	~$152 million	3.4%	Expansion into emerging markets
2025	~$157 million	3.3%	Growing procedures, new protocols
2026	~$162 million	3.2%	Competitive differentiation
2027	~$168 million	3.0%	Market maturity, slight deceleration

Assumptions: Steady procedural growth, stable safety profile, gradual regulatory tightening.

Key Influencing Factors

• Procedural Volume Growth: 5-6% annually globally.
• Market Penetration in Emerging Markets: Increasing, up to 20% of sales by 2027.
• Regulatory Limitations: Potential restrictions could temper growth.
• Innovation: Introduction of lower osmolarity agents (e.g., LOIS contrast media) may impact ULTRAVIST 300's share.

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Comparative Analysis: ULTRAVIST 300 vs. Competitors

Feature	ULTRAVIST 300	Omnipaque	Visipaque	Visipaque (iodixanol)	Key Differentiators
Iodine Concentration	300 mg/mL	350 mg/mL	320 mg/mL	320 mg/mL	Higher concentration for contrast
Osmolarity	Low osmolar (530 mOsm/kg)	Low osmolar	Iso-osmolar	Iso-osmolar	Safety profile variations
Safety Profile	Well-established	Slightly higher risk	Safer	Safer	Consistent safety data
Market Share	~70%	20%	7%	3%	Brand dominance

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Key Market Inhibitors and Opportunities

Inhibitors

• Safety Risks and Allergic Reactions: Increased safety concerns may restrict broader use.
• Regulatory Restrictions: Stricter warning labels and usage criteria.
• Environmental Concerns: Iodinated contrast agents’ environmental persistence.

Opportunities

• Emerging Markets: Growing healthcare infrastructure creates new demand.
• Pharmacovigilance Improvements: Safer formulations and protocols.
• Technological Advances: Integration with AI-driven imaging improves diagnostic accuracy.

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Key Takeaways

• Steady but moderated growth is expected for ULTRAVIST 300, averaging around 3–3.5% annually through 2027.
• Global procedural increases in diagnostic imaging underpin demand, especially in Asia-Pacific and Latin America.
• Pricing stability is challenged by regional procurement policies, but volume growth could offset margins.
• Regulatory and safety concerns necessitate ongoing adaptation, including potential product reformulation or repositioning.
• The competitive landscape favors Bayer’s established brand but faces competition from newer, potentially safer contrast agents.

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FAQs

Q1: How does ULTRAVIST 300 compare to newer contrast agents?
A: ULTRAVIST 300 offers high iodine concentration and proven safety, but newer iso-osmolar agents like Visipaque provide improved safety profiles, influencing prescribing behaviors.

Q2: Which markets will drive future growth for ULTRAVIST 300?
A: Emerging markets in Asia-Pacific and Latin America are projected to contribute significantly due to increasing healthcare infrastructure and diagnostic imaging adoption.

Q3: What regulatory changes could impact ULTRAVIST 300’s sales?
A: Stricter safety warnings, usage restrictions in vulnerable populations, and environmental regulations can influence sales volume and formulation standards.

Q4: How does safety concerns affect the utilization of iodinated contrast media?
A: Risks such as allergic reactions and nephrotoxicity lead to cautious use, especially in high-risk groups, potentially limiting growth.

Q5: What is the outlook for innovation within the iodinated contrast media segment?
A: The industry is pursuing lower osmolar, safer contrast agents and alternative imaging modalities, which may challenge traditional products like ULTRAVIST 300 over the long term.

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References

1. [1] MarketWatch. (2022). Global Contrast Media Market.
2. [2] Global Radiology Procedures Data, (2022). IQVIA.
3. [3] FDA. (2022). Drug Approval and Safety Information.
4. [4] European Medicines Agency. (2017). Safety Announcement on Iodinated Contrast Agents.