ULTRAVIST 370 Drug Patent Profile

When do Ultravist 370 patents expire, and when can generic versions of Ultravist 370 launch?

Ultravist 370 is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in ULTRAVIST 370 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 370

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for ULTRAVIST 370

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

International Patents for ULTRAVIST 370

See the table below for patents covering ULTRAVIST 370 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
Yugoslavia	61780
Canada	1130316	DIAMIDES D'ACIDE ISOPHTALIQUE TRI-IODES UTILISES COMME AGENTS DE CONTRASTE NON IONIQUES POUR RAYONS X (TRI-IODATED ISOPHTHALIC ACID DIAMIDES AS NON-IONIC X-RAY CONTRAST AGENTS)
Spain	491254
Mexico	9203691	NUEVOS MEDIOS DE CONTRASTE DE RAYOS X NO IONICOS.

Summary
ULTRAVIST 370, a high-concentration iodinated contrast agent, positions itself in the diagnostic imaging market, particularly for CT scans and angiography. Its prospects depend on the broader transition to advanced imaging procedures, regulatory environment, and competition from alternative agents. The drug’s current market share, patent status, and pipeline developments influence its investment viability.

Market Overview and Fundamentals

Product Profile and Use Cases
ULTRAVIST 370 (ioversol injection) is used predominantly in diagnostic imaging procedures requiring contrast enhancement. Its intended use includes angiography, CT scans, and other radiological techniques. It is characterized by its high iodine concentration (370 mg/mL), which offers clearer imaging.

Market Penetration and Revenue
The global contrast media market was valued at approximately $4.8 billion in 2021 and is projected to grow at a CAGR of 5.2% through 2028 (aligned with imaging procedure growth and technological advancements). ULTRAVIST 370 holds a notable share within the iodinated contrast agents segment but faces stiff competition from agents like iohexol and iopamidol, which often feature lower costs.

Regulatory and Patent Landscape
ULTRAVIST received FDA approval in 1998, with patent protections expiring around 2010. Generic versions have entered markets in the U.S. and Europe, exerting price pressure. Market exclusivity is limited; however, the drug's brand recognition sustains some premium pricing.

Competitive Positioning
Key competitors include:

• Iohexol (e.g., Omnipaque): Lower cost, wider adoption for non-urgent imaging.
• Iopamidol (e.g., Isovue): Similar efficacy, marketed broadly in hospitals.
• Other brands: Such as Telebrix and Visipaque, with varying iodine concentrations and safety profiles.

ULTRAVIST 370's high iodine concentration makes it suitable for specific protocols but limits its market when alternatives suffice.

R&D and Pipeline Considerations
No recent pipeline developments or reformulations are publicly documented for ULTRAVIST 370, indicating limited near-term innovation prospects. The focus has shifted towards alternative imaging agents and drug delivery methods.

Regulatory Trends and Policy Environment
Medical device and pharmaceutical pricing pressures, especially in Europe and the U.S., impact margins. The FDA has issued guidelines on iodine contrast agents concerning adverse reactions, potentially influencing formulary preferences.

Financial Fundamentals

• Revenue Trends: Declining in some regions due to generic competition, though stable in niche markets or via hospital procurement contracts.
• Pricing Dynamics: Margins are under pressure from low-cost generics, with typical contrast agent pricing around $5–$20 per dose.
• Cost Structure: Manufacturing costs are relatively low, but marketing and distribution constitute significant expense, especially in multiple markets.

Investment Considerations

Factor	Analysis	Implication
Patent expiry	Patents expired by 2010; generics prevalent	Price erosion, volume-based profitability
Market growth	Moderate, driven by healthcare infrastructure expansion	Supports steady revenue if maintained
Competition	Intense from generics and alternative agents	Margin compression
Regulatory environment	Stringent guidelines increase compliance costs	Adds to barriers for new formulations
Innovation pipeline	Limited pipeline; no recent reformulations	Offsets potential for growth

Investment Outlook Summary
ULTRAVIST 370 operates within a mature segment facing pricing pressures. Its long-term viability depends on maintaining market share through institutional contracts, differentiation in safety or efficacy, or potential niche applications.

Key Takeaways

Last updated: February 9, 2026

• The product’s revenue is declining in mature markets due to generics.
• Growth prospects hinge on expanding into emerging markets and hospital procurement.
• Competition and pricing pressure limit margins, with limited innovation pipeline support.
• Regulatory pressures could influence formulary positioning.
• The lack of recent R&D investment suggests stability but limited upside.

FAQs

1. What is the primary driver of demand for ULTRAVIST 370?
   The growth in demand for diagnostic imaging procedures, especially CT and angiography, sustains the need. However, generic competition limits growth potential.

2. How does patent expiry impact ULTRAVIST 370’s market?
   Patent expiry led to widespread generic entry, reducing prices and margins, and increasing price sensitivity among providers.

3. Can innovation or reformulation revive ULTRAVIST 370's market position?
   Limited R&D suggests minimal near-term innovation. Future growth depends on niche applications or formulation improvements.

4. What regulatory factors could influence its market?
   Safety guidelines for contrast agents, especially related to adverse reactions, could lead to formulary restrictions or incentivize alternative agents.

5. Is investing in ULTRAVIST 370 advisable?
   A conservative approach is recommended; the product faces headwinds from generic competition but benefits from established hospital relationships and a stable market niche.

References

1. MarketsandMarkets. Contrast Media Market Size, Share & Trends Analysis (2021–2028).
2. FDA. Guidance for Industry: Use of iodinated contrast media in diagnostic imaging. (2022).
3. Pharmaceutical Commerce. Contrast media market analysis and competitive landscape report. (2021).