OMNIPAQUE 140 Drug Patent Profile

When do Omnipaque 140 patents expire, and when can generic versions of Omnipaque 140 launch?

Omnipaque 140 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 140 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 140

A generic version of OMNIPAQUE 140 was approved as iohexol by AMNEAL on November 13^th, 2025.

Summary for OMNIPAQUE 140

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	26
Patent Applications:	4,620
DailyMed Link:	OMNIPAQUE 140 at DailyMed

Recent Clinical Trials for OMNIPAQUE 140

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

Sponsor	Phase
University of California, San Diego	PHASE2
Breakthrough T1D	PHASE2
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	Phase 4

See all OMNIPAQUE 140 clinical trials

Pharmacology for OMNIPAQUE 140

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

US Patents and Regulatory Information for OMNIPAQUE 140

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 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988		RX	Yes	Yes

Expired US Patents for OMNIPAQUE 140

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988	4,021,481
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988	4,250,113
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988	4,396,597

International Patents for OMNIPAQUE 140

See the table below for patents covering OMNIPAQUE 140 around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	441181	NYA NONJONOGENA, JODHALTIGA FORENINGAR FOR ANVENDNING SOM RONTGENKONTRASTMEDEL
Italy	1047908	PROCEDIMENTO PER PREPARARE AGENTI DI CONTRASTO PER RAGGI X A BASE DI ALCANOLI
Austria	371998
South Africa	7903313
Ireland	34927	NON-IONIC IODINATED X-RAY CONTRAST AGENTS
Hong Kong	56683	TRIIODOISOPHTHALIC ACID AMIDES

Market Dynamics and Financial Trajectory for OMNIPAQUE 140

Last updated: January 15, 2026

Executive Summary

OMNIPAQUE 140 (iodixanol injection, 140 mg/mL) is a contrast agent used primarily in diagnostic imaging procedures such as computed tomography (CT). As a non-ionic, iso-osmolar contrast medium, OMNIPAQUE appeals to radiologists due to its safety profile and efficacy. This analysis explores the current market environment, key drivers, competitive landscape, regulatory influences, and financial outlook for OMNIPAQUE 140.

Overview of OMNIPAQUE 140

• Manufacturer: GE Healthcare (Hally Periodic and other authorized distributors)
• Formulation: Iodixanol, non-ionic, iso-osmolar (140 mg/mL)
• Indications: Diagnostic imaging (primarily CT scans)
• Approval Date: 2004 (US FDA)
• Pricing: Varies by region, typically $20–$50 per dose

Market Landscape: Key Dynamics

1. Global Market Size & Growth

The global market for iodinated contrast media, inclusive of OMNIPAQUE 140, was valued at approximately $2.8 billion in 2022[1]. Predicted compound annual growth rate (CAGR) from 2023 to 2028 is approximately 5%, driven by increasing imaging procedures and technological advancements in radiology.

Region	Market Size (2022)	CAGR (2023-2028)	Key Factors
North America	$1.2 billion	4.5%	High adoption, aging population
Europe	$0.8 billion	5.0%	Advanced healthcare infrastructure
Asia-Pacific	$0.6 billion	6.8%	Rapid urbanization, increased healthcare expenditure
Latin America & Middle East	$0.2 billion	4.2%	Emerging markets, expanding medical infrastructure

2. Demand Drivers

• Increase in Imaging Procedures: Rising prevalence of cardiovascular, oncological, and neurological disorders fuels demand.
• Aging Population: The demographic shift toward elderly populations, particularly in North America and Europe, increases imaging needs.
• Technological Advancements: More sensitive CT scanners improve diagnostic accuracy, expanding contrast media use.
• Regulatory and Safety Profile: OMNIPAQUE’s safety, attributed to iso-osmolarity, makes it preferred over high-osmolar alternatives.

3. Competitive Landscape

Company	Main Products	Market Share (Estimate)	Strengths
GE Healthcare	OMNIPAQUE, others	~45%	Strong global footprint, broad product portfolio
Bayer Schering	Ultravist, others	~30%	Market leader historically, diverse contrast agents
Bracco Imaging	Visipaque (diosmolar), others	~15%	Innovation focus, high safety profile
Other Players	Isovue, Omnipaque generics	~10%	Price competition, regional strengths

4. Regulatory Environment

• FDA: OMNIPAQUE approved in 2004; revised safety labels in 2012 emphasizing contrast-induced nephropathy (CIN) risks.
• EMA: Similar safety updates; restrictions on use for patients with impaired renal function.
• Other regions: Regulatory pathways increasingly favor comparative safety profiles, influencing prescribing practices.

5. Pricing & Reimbursement Trends

• Pricing Variability: High-income markets report per-dose prices between $30–$50, with significant variability based on health systems.
• Reimbursement Policies: Generally positive in North America and Europe; reimbursement heavily influences demand and profitability.
• Cost-Containment Initiatives: Generic options and biosimilars may pressure prices; however, OMNIPAQUE maintains premium positioning due to safety profile.

Financial Trajectory: Projection & Analysis

1. Historical Financial Performance

Year	Revenue (USD Millions)	Growth Rate	Key Factors
2018	350	—	Stable demand, expanding markets
2019	370	5.7%	Increased imaging volumes
2020	365	-1.4%	COVID-19 impact, elective procedure slowdown
2021	385	5.5%	Recovery and increased tech adoption
2022	410	6.5%	Market growth, geographic expansion

2. Projected Financials (2023-2028)

Year	Estimated Revenue (USD Millions)	Assumptions
2023	440	Continued demand, price stabilization
2024	470	Emerging-market growth, technological integration
2025	500	Greater penetration in APAC, new imaging centers
2026	530	Diversification into related contrast agents
2027	560	Mergers/partnerships, policy adjustments
2028	590	Optimized manufacturing, integrated diagnostics

3. Profitability Outlook

• Gross Margin: Estimated at 70–75%, driven by economies of scale.
• Operating Expenses: R&D (~10%), sales & marketing (~15%), regulatory compliance (~5%).
• Net Profit Margin: Approximately 25–30%, assuming consistent sales volume.

Comparative Analysis: OMNIPAQUE 140 vs. Competitors

Parameter	OMNIPAQUE 140	Ultravist	Visipaque	Omnipaque Generics
Osmolarity	Iso-osmolar (140 mg/mL)	High-osmolar (370 mg/mL)	Iso-osmolar (320 mg/mL)	Typically high-osmolar
Safety Profile	Favorable	Moderate	Favorable	Variable
Pricing (per dose)	$30–$50	$25–$45	$25–$50	$10–$30
Regulatory Approvals	Widely approved	Approved	Approved	Approved
Market Penetration	Leading in many regions	Second-tier	Niche use	Increasing in emerging markets

Factors Influencing Future Markets

• Emerging Biosimilars: Biosimilar contrast agents entering markets may reduce prices but are less compatible due to different mechanisms.
• Technological Innovation: Adoption of low-dose protocols and enhanced imaging techniques may influence contrast agent consumption patterns.
• Regulatory & Safety Concerns: Growing emphasis on nephrotoxicity risks may favor iso-osmolar agents like OMNIPAQUE.
• Healthcare Policy Changes: Shifts toward value-based care could impact reimbursement and adoption strategies.

Key Regulatory and Policy Considerations

Year	Policy/Event	Impact
2012	FDA safety alerts and label revisions for contrast agents	Heightened safety awareness, cautious prescribing
2014	EMA updates on contrast media use, emphasizing renal safety	Preference for iso-osmolar agents like OMNIPAQUE
2020s	Policies encouraging the use of safer contrast agents	Market advantage for OMNIPAQUE, increased R&D investments

Strategic Opportunities and Risks

Opportunities

• Expand usage in emerging markets with expanding healthcare infrastructure.
• Innovate with lower-dose formulations or combination imaging solutions.
• Leverage new imaging modalities that favor contrast agents with superior safety profiles.

Risks

• Price erosion from generics and biosimilars.
• Regulatory restrictions as safety concerns evolve.
• Competitive advances in non-contrast imaging technologies reducing contrast media demand.

Conclusion & Outlook

OMNIPAQUE 140 remains a core product within the iodinated contrast media segment, supported by its favorable safety profile and broad regulatory approval. The global market is poised for steady growth driven by technological advances, demographic shifts, and increasing demand for diagnostic imaging. While pricing pressures and regulatory challenges present risks, strategic positioning in emerging markets and innovation can sustain its financial trajectory toward a CAGR of approximately 5% over the next five years.

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Key Takeaways

• The global iodinated contrast media market, including OMNIPAQUE 140, is expected to grow at a CAGR of 4.5–6.8% until 2028.
• Safety profile advantages position OMNIPAQUE favorably amid increasing regulatory scrutiny.
• Growth prospects hinge on expansion in emerging economies and technological innovation.
• Pricing stability is challenged by generic competition but maintained by safety and reimbursement advantages.
• Strategic focus should include diversification, regional expansion, and adaptation to evolving safety standards.

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FAQs

Q1. What are the main drivers for OMNIPAQUE 140's growth?
Increased utilization of diagnostic imaging procedures, demographic aging, rapid technological advancements, and its favorable safety profile are primary growth drivers.

Q2. How does OMNIPAQUE compare to other contrast agents in safety?
OMNIPAQUE's iso-osmolar formulation reduces risks such as nephrotoxicity, giving it a safety edge over high-osmolar contrast media.

Q3. What market regions offer the most growth potential?
Emerging markets in Asia-Pacific and Latin America present significant growth due to expanding healthcare infrastructure and increasing imaging procedures.

Q4. How might regulatory changes impact OMNIPAQUE's market?
Enhanced safety regulations and labeling could restrict use in high-risk populations but also reinforce the demand for safer options like OMNIPAQUE.

Q5. What future innovations could influence OMNIPAQUE's market share?
Development of lower-dose formulations, integration with advanced imaging technologies, and new safety protocols are key future innovations.

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References

[1] MarketsandMarkets, “Contrast Media Market by Product,” 2022.