ULTRAVIST 300 Drug Patent Profile

Which patents cover Ultravist 300, 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

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

International Patents for ULTRAVIST 300

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

Country	Patent Number	Title	Estimated Expiration
Finland	73199
Ireland	49647	NON-IONIC X-RAY CONTRAST AGENTS
Egypt	14530	NON-IONIC X-RAY CONTRAST AGENTS

Ultravist 300 Investment and Fundamentals Analysis

Last updated: February 9, 2026

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What Is Ultravist 300?

Ultravist 300 is a contrast agent with iohexol as the active pharmaceutical ingredient (API). It is used in medical imaging procedures such as computed tomography (CT) scans to enhance the visibility of blood vessels, tissues, and organs.

Market Overview and Demand Drivers

Global Market Size

The global computed tomography (CT) contrast agents market was valued at approximately $1.8 billion in 2021 and is projected to reach $2.8 billion by 2028, growing at a compound annual growth rate (CAGR) of 6.2% from 2022 to 2028 [1].

Key Growth Drivers

• Increasing prevalence of chronic diseases requiring diagnostic imaging.
• Rising adoption of minimally invasive diagnostic procedures in emerging markets.
• Aging population globally, leading to higher incidence of degenerative diseases requiring imaging.
• Technological advancements in imaging modalities and contrast media formulations.

Segment Breakdown

Within contrast agents, iodinated contrast media (ICM) like Ultravist 300 account for approximately 75% of the market. The remaining is primarily filled by gadolinium-based agents and microbubble ultrasound contrast agents [2].

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Competitive Position and Patent Landscape

Core Competitors

• Bayer’s Ultravist 300 holds a significant market share.
• GE Healthcare's Omnipaque (iohexol-based).
• Bracco Imaging's Visipaque (iodixanol).
• General manufacturers of iodinated contrast agents operating in similar dose ranges.

Patent Considerations

• Ultravist 300's formulation patents in the US expired around 2017, opening the field for generics.
• Brand loyalty persists due to safety profiles and physician preference.
• Generic competition now accounts for an increasing share, challenging profit margins.

Regulatory Barriers

• FDA, EMA, and other regulators require extensive safety and efficacy data.
• Biosimilar and generic entrants face patent litigations and certifications.

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Financial Fundamentals

Revenue Streams

• Primarily from sales of Ultravist 300 to hospitals, diagnostic labs, and private clinics.
• Pricing strategies influenced by regional regulations, reimbursement policies, and generic competition.

Price Trends

• In North America and Europe, prices have declined approximately 15-20% since patent expiration due to increased generics.
• Emerging markets witness higher prices relative to local income levels but experience growing demand.

Cost Structure

• Production costs for iohexol are relatively stable owing to efficient synthesis.
• R&D expenditures are minimal for established formulations but must be maintained for new indications or formulations.
• Regulatory compliance and distribution logistics are significant cost factors.

Profitability Outlook

• Branded products like Ultravist 300 maintain higher margins (~30-40%) due to brand loyalty.
• Generics' margins are narrower (~10-15%) but benefit from higher sales volume.

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Investment Risks and Opportunities

Risks

• Patent expiry leading to increased generic competition.
• Regulatory hurdles in key markets.
• Potential safety concerns or adverse events impacting market perception.
• Pricing pressures from health authorities and payers.

Opportunities

• Expansion into new geographic markets, particularly Asia-Pacific.
• Development of new formulations or additional indications.
• Strategic partnerships with healthcare providers for bundled offerings.
• Adoption of digital health integrations to enhance imaging diagnostics.

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Regulatory Environment and Pathways

• Regulatory pathways vary regionally; the US FDA approves via new drug application (NDA) or abbreviated pathways for generics.
• In Europe, the EMA’s centralized procedure standardizes approval.
• Patent litigation delays are common; timely filing and legal preparedness are vital.

Key Takeaways

• Ultravist 300 operates in a mature market with steady demand driven by global healthcare needs.
• Patent expirations have increased generic competition, pressuring prices but expanding market reach.
• The product's profitability depends on regional pricing, regulatory environments, and brand loyalty.
• Growth hinges on geographic expansion, innovative formulations, and clinical adoption.
• Regulatory and patent risks must be monitored, especially in high-value markets like the US and Europe.

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FAQs

1. What is the primary revenue for Ultravist 300?

Sales to hospitals and diagnostic clinics across global markets, driven by ongoing demand for imaging procedures.

2. How has patent expiration affected Ultravist 300?

Patent expiration has led to increased generic competition, reducing prices but expanding market access through lower-cost alternatives.

3. What are the main barriers to new entrants in this market?

Regulatory approval processes, established brand loyalty, and patent litigation challenges.

4. Which regions present major growth opportunities?

Asia-Pacific and Latin America, driven by rising healthcare infrastructure and diagnostic procedures.

5. How are safety and efficacy concerns influencing the market?

Perceptions of safety, particularly regarding adverse reactions, influence physician choice and regulatory scrutiny, impacting market share.

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References

[1] MarketsandMarkets. "Contrast Media Market by Type, Application, and Region – Global Forecast to 2028." 2022.

[2] Grand View Research. "Contrast Media Market Size, Share & Trends Analysis." 2022.