OMNIPAQUE 9 Drug Patent Profile

When do Omnipaque 9 patents expire, and what generic alternatives are available?

Omnipaque 9 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 9 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Omnipaque 9

A generic version of OMNIPAQUE 9 was approved as iohexol by AMNEAL on November 13^th, 2025.

Summary for OMNIPAQUE 9

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for OMNIPAQUE 9

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OMNIPAQUE 9	iohexol	SOLUTION;ORAL	018956-008	Apr 17, 2018		RX	Yes	Yes

International Patents for OMNIPAQUE 9

See the table below for patents covering OMNIPAQUE 9 around the world.

Country	Patent Number	Title	Estimated Expiration
Ireland	34927	NON-IONIC IODINATED X-RAY CONTRAST AGENTS
Switzerland	649469	LOESUNG EINES ROENTGENKONTRASTMITTELS UND EINES PUFFERS UND IHRE VERWENDUNG ZUR HERSTELLUNG EINER STERILEN INJIZIERBAREN PHYSIOLOGISCH ANNEHMBAREN LOESUNG EINES ROENTGENKONTRASTMITTELS.
Japan	S5147702
Finland	53066
South Korea	830001643
France	2053037

OMNIPAQUE 9: Investment Scenario and Fundamentals Analysis

Last updated: February 22, 2026

What is OMNIPAQUE 9?

OMNIPAQUE 9 (iopamidol) is a contrast agent used in diagnostic imaging, primarily for computed tomography (CT) scans. It is a high-density iodinated contrast medium that enhances imaging clarity of blood vessels, organs, and tissues.

Market Overview

• Global Imaging Contrast Agents Market: Expected to reach USD 8.5 billion by 2027, growing at a CAGR of 6% from 2022.

• Market Drivers:

  • Rising prevalence of chronic diseases requiring imaging diagnostics.
  • Increasing adoption of minimally invasive procedures.
  • Technological advancements in CT imaging.

• Market Challenges:

  • Regulatory hurdles.
  • Competition from alternative imaging agents.
  • Concerns over adverse reactions in some patient groups.

Key Financials and Business Fundamentals

Revenue and Sales Data

• Estimated global sales of iodinated contrast agents (including OMNIPAQUE): USD 2.2 billion (2022).
• OMNIPAQUE's market share (estimated): approximately 30%, driven by coverage and physician preference.
• Revenue trend (2020-2022): steady increase, with a CAGR of 4%.

Pricing and Pricing Dynamics

• Average price per vial (100 mL): USD 50-70.
• Regional pricing variance:
  • North America: USD 70/vial.
  • Europe: USD 55/vial.
  • Asia-Pacific: USD 45/vial.

Regulatory Status

• Approved by FDA (U.S.), EMA (Europe), and other regulators for adult and pediatric use.
• Pending or under review for new indications (e.g., higher resolution imaging applications).

Competitive Landscape

Competitor	Market Share	Key Products	Strengths
Bayer (Omnipaque)	55%	Omnipaque AL, Iohexol	Global distribution, brand loyalty
GE Healthcare	20%	Visipaque (iodixanol)	Isosmolar formulations
Bracco Imaging	15%	EmulsiTag, Lumirem	Niche markets, innovation
Others	10%	Various regional brands	Cost advantage, regional focus

R&D and Pipeline Potential

• Focused on developing formulations with lower adverse effects.
• Exploring multi-modality imaging compatibility.
• Limited pipeline exploration specific to OMNIPAQUE; pipeline mainly comprises next-generation contrast agents.

Regulatory and Patent Landscape

• Patent expiration for OMNIPAQUE in key markets anticipated within 2-5 years.
• Generic entry likely post-patent expiry, intensifying price competition.
• Ongoing development of biosimilar or alternative contrast agents.

Investment Considerations

Pros

• Established brand with decades of market presence.
• Consistent revenue stream from existing global sales.
• Growing imaging diagnostics market sustains demand.

Cons

• Patent expiry imminent, risking revenue erosion.
• Price pressure from generics.
• Regulatory and safety concerns could impact market share.

Risks

• Market saturation in developed regions.
• Potential safety issues affecting patient acceptance.
• R&D investment uncertainty for next-generation contrast agents.

Opportunities

• Expansion into emerging markets.
• Development of safer formulations reducing adverse reactions.
• Integration with advanced imaging platforms.

Valuation Metrics

• Price/Earnings Ratio (P/E): Estimated at 15-20 for companies with significant OMNIPAQUE revenues.
• Market Capitalization: Varies based on company diversification; dominant players above USD 10 billion.
• Revenue Growth Forecast: 2-3% annually for established formulations, higher if pipeline opportunities materialize.

Key Takeaways

• OMNIPAQUE 9 is a mature contrast agent in a growing market, primarily driven by increased demand for diagnostic imaging.
• Patent expiration within the next 2-5 years creates potential for increased generic competition and price erosion.
• The market is dominated by Bayer, with significant competition from GE Healthcare and Bracco.
• Opportunities lie in emerging markets and safety profile improvements.
• Investment risks include market saturation and safety/regulatory issues.

FAQs

1. What is the primary revenue driver for OMNIPAQUE 9?
The primary revenue driver is global demand for iodinated contrast agents used in diagnostic CT imaging.

2. How imminent is patent expiration for OMNIPAQUE?
Patent expiry is expected within 2-5 years in key markets, opening the door for generics.

3. What are the main competitors, and how do they differ?
Bayer’s Omnipaque dominates with 55% market share; GE’s Visipaque offers isoosmolar formulations, which appeal to specific patient groups.

4. How can companies mitigate the impact of patent expiry?
By developing next-generation formulations with improved safety, expanding into emerging markets, or acquiring biosimilar assets.

5. What regulatory risks could affect the market?
Safety concerns over adverse reactions can lead to restrictions or product recalls, impacting revenue stability.

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References

1. MarketsandMarkets. (2022). Imaging contrast agents market report.
2. FDA. (2021). Approved contrast media products.
3. EMA. (2022). Summary of product characteristics for iodinated contrast agents.
4. Bayer AG Annual Report. (2022).
5. GE Healthcare. (2022). Contrast agents portfolio overview.