ULTRAVIST (PHARMACY BULK) Drug Patent Profile

When do Ultravist (pharmacy Bulk) patents expire, and what generic alternatives are available?

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.

Summary for ULTRAVIST (PHARMACY BULK)

US Patents:	0
Applicants:	1
NDAs:	1

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
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-001	Sep 20, 2002		RX	Yes	Yes
Bayer Hlthcare	ULTRAVIST (PHARMACY BULK)	iopromide	INJECTABLE;INJECTION	021425-002	Sep 20, 2002		RX	Yes	Yes

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
European Patent Office	0015867	DIAMIDES OF TRIIODO-ISOPHTHALIC ACIDS, THEIR PREPARATION AND X-RAY CONTRAST AGENTS CONTAINING THEM
Mexico	9203691	NUEVOS MEDIOS DE CONTRASTE DE RAYOS X NO IONICOS.
Yugoslavia	61780
Germany	2909439
Finland	800696

Last updated: February 9, 2026

What Are the Market Fundamentals for ULTRAVIST (PHARMACY BULK)?

ULTRAVIST (iopamidol) is a contrast agent used in radiological imaging, particularly for contrast-enhanced computed tomography (CT). It is marketed as a pharmacy bulk package in the United States, primarily serving hospitals and imaging centers. The drug's market dynamics depend on the radiology sector, regulatory status, and competition.

What Is the Size and Growth of the Contrast Agent Market?

The global contrast media market was valued at approximately $4.2 billion in 2022, with a projected CAGR of 4.5% from 2023 to 2030. North America accounts for roughly 40% of the market, driven by high healthcare expenditure and increasing diagnostic imaging procedures.

The specific segment for iodinated contrast agents, such as ULTRAVIST, comprises about 60% of the total contrast media market, valued at approximately $2.5 billion in 2022. The demand correlates with the number of CT examinations, which increased by approximately 6% annually worldwide.

How Does ULTRAVIST Fit into the Competitive Landscape?

ULTRAVIST faces competition from other iodinated contrast agents, including:

• Iohexol (brand: Omnipaque)
• Iopromide (brand: Ultravist)
• Iodixanol (brand: Visipaque)
• Ioversol (brand: Optiray)

Market leadership is split among a few key players, with GE Healthcare, Bayer, and GE Healthcare holding significant shares. Bayer's Ultravist (iopromide) was the leading iodinated contrast agent in 2022, with an estimated 20% market share, followed by GE Healthcare's Omnipaque and Bayer's Ultravist.

ULTRAVIST’s sales are influenced by:

• Institutional contracts with hospitals and imaging centers.
• Regulatory approvals and patent status.
• Clinical preferences based on safety profiles and imaging quality.

What Are the Regulatory and Patent Considerations?

ULTRAVIST is approved in multiple regions, including the U.S. (FDA approved), European Union, and Japan. Its patent exclusivity has mostly expired or is nearing expiration in key markets, allowing generic manufacturing to enter the market.

In the U.S., the pharmacy bulk package formulation is classified under FDA regulations as a sterile drug, with specific handling and storage guidelines. Patent expiration, which typically occurred for Bayer’s formulations in the past, can lead to increased generic competition and price erosion.

What Are Recent R&D and Market Pipeline Trends?

Research efforts focus on improving contrast agents' safety profile, reducing adverse reactions, and enhancing image quality. New formulations aim to lower osmolality and improve tolerability.

Bayer and other companies are exploring alternative agents, including non-iodinated contrast media and novel delivery systems. However, no significant patent filings or regulatory approvals for new formulations of ULTRAVIST have been reported recently.

What Is the Investment Outlook for ULTRAVIST?

Key factors influencing investment include:

• Market Demand: Increasing imaging procedures, aging populations, and rising awareness of diagnostic imaging support steady demand.

• Pricing Trends: Generics and increased competition put downward pressure on prices; however, hospital contracts and formulary preferences can sustain margins.

• Regulatory Risks: Changes in FDA policies or new safety regulations could impact sales.

• Supply Chain: Manufacturing complexities and raw material availability affect product availability and costs.

While the segment is mature, stable revenues derive from the essential nature of contrast media. Emerging trends such as AI-driven imaging and alternative contrast agents could influence long-term growth or decline.

Summarized Financials and Market Position

Due to the proprietary nature of specific sales data, public information indicates:

Aspect	Details
Market Size (2022)	Approximately $2.5 billion for iodinated contrast agents globally
Major Competitors	GE Healthcare (Omnipaque), Bayer (Ultravist), GE Healthcare (Visipaque)
Market Share (est.)	Bayer’s Ultravist around 15-20% in the iodinated contrast space
Patent Status	Patents expired or nearing expiration; generics available
R&D Activity	Focused on safety, tolerability, and imaging efficacy

What Are the Key Risks and Opportunities?

Risks:

• Increased generic competition leading to price erosion.
• Regulatory changes impacting manufacturing or approval status.
• Safety concerns or adverse event reports affecting market perception.
• Technological shifts toward non-iodinated contrast media.

Opportunities:

• Market expansion in emerging economies with growing imaging infrastructure.
• Development of improved formulations with better safety profiles.
• Strategic partnerships with hospitals and radiology clinics.

Key Takeaways

• ULTRAVIST operates in a mature, highly competitive iodinated contrast media market worth approximately $2.5 billion globally.
• Market growth is steady, driven by higher diagnostic imaging rates, but faces downward pressure from generics and pricing.
• The competitive landscape is dominated by legacy brands, with Bayer’s Ultravist holding a significant share.
• Patent expirations open the field for generics, likely reducing margins.
• R&D focuses on safety improvements, with no current pipeline of innovative formulations scaling for ULTRAVIST.
• Investment risks include market saturation and regulatory shifts; opportunities exist in emerging markets and incremental safety enhancements.

FAQs

1. How does patent expiration affect ULTRAVIST's market position?
Patent expirations lead to increased generic versions, which generally lower prices and reduce Bayer’s market share and profit margins.

2. Are there regulatory hurdles for new contrast agents?
Yes. Regulatory agencies require extensive safety and efficacy data for new formulations or delivery methods, which can delay or prevent market entry.

3. How do safety profiles influence demand for ULTRAVIST?
Safety concerns can lead hospitals to prefer alternative contrast agents with lower adverse reaction rates, impacting ULTRAVIST's sales.

4. What is the outlook for growth in contrast media?
Global contrast media sales are expected to grow modestly (~4.5% CAGR) due to rising imaging procedures, aging populations, and expanding healthcare infrastructure.

5. How does ULTRAVIST compete against alternative imaging options?
Its competitiveness depends heavily on imaging performance, safety profile, pricing, and hospital contracts, but it faces saturation and pricing pressures from generics and emerging technologies.

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Citations

1. "Contrast Media Market," Grand View Research, 2022.
2. "Iodinated Contrast Media Market," MarketsandMarkets, 2022.
3. Bayer Annual Reports, 2022.
4. FDA Drug Approvals and Labeling, 2022.
5. "Global Radiology Imaging Market," Research and Markets, 2022. [1] https://www.grandviewresearch.com/industry-analysis/contrast-media-market
   [2] https://www.marketsandmarkets.com/Market-Reports/iodinated-contrast-media-market-239357420.html
   [3] Bayer Annual Reports 2022.
   [4] FDA Drug Approvals Database, 2022.
   [5] Research and Markets, 2022.