Iohexol - Generic Drug Details

What are the generic sources for iohexol and what is the scope of patent protection?

Iohexol is the generic ingredient in eleven branded drugs marketed by Interpharma Praha As, Ge Healthcare, and Amneal, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for iohexol. Three suppliers are listed for this compound.

Summary for iohexol

US Patents:	0
Tradenames:	11
Applicants:	3
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	75
What excipients (inactive ingredients) are in iohexol?	iohexol excipients list
DailyMed Link:	iohexol at DailyMed

Recent Clinical Trials for iohexol

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

Sponsor	Phase
MediBeacon	NA
University Hospital, Tours	NA
University Hospitals Cleveland Medical Center	NA

See all iohexol clinical trials

Pharmacology for iohexol

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

Medical Subject Heading (MeSH) Categories for iohexol

Contrast Media

Anatomical Therapeutic Chemical (ATC) Classes for iohexol

V08AB	Watersoluble, nephrotropic, low osmolar X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for iohexol

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 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985		RX	Yes	Yes
Interpharma Praha As	ORALTAG	iohexol	FOR SOLUTION;ORAL	205383-001	Mar 26, 2015		DISCN	No	No
Ge Healthcare	OMNIPAQUE 9	iohexol	SOLUTION;ORAL	018956-008	Apr 17, 2018		RX	Yes	Yes
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	020608-001	Oct 24, 1995		DISCN	No	No
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985	AP	RX	Yes	Yes

Expired US Patents for iohexol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 70	iohexol	SOLUTION;URETHRAL	018956-007	Jun 1, 1994
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985

Market Dynamics and Financial Trajectory for Iohexol

Last updated: December 23, 2025

Executive Summary

Iohexol, a non-ionic, water-soluble iodinated contrast agent predominantly used in diagnostic imaging, has maintained a significant presence in medical imaging markets globally. Its favorable safety profile relative to older ionic contrast agents and extensive regulatory approval have supported sustained demand. As the global healthcare industry shifts towards advanced imaging techniques and minimally invasive diagnostics, Iohexol's market landscape is poised for nuanced evolution. This report delves into the current market dynamics, financial trajectories, competitive landscape, regulatory influences, and future growth prospects for Iohexol, providing actionable insights for stakeholders.

---

What is Iohexol and Why Does It Matter?

Iohexol (marketed as Omnipaque, Gevokid, among others) is an organic iodine compound used in diagnostic procedures such as computed tomography (CT) scans and angiography. Its high safety profile, low osmolality, and compatibility with various administration routes have cemented its prominence.

Key Specifications:

Attribute	Details
Molecular Formula	C′35H₄₆I₃N₃O₁₂
Iodine Content	300 mg/mL (standard concentration)
Osmolality (mOsm/kg)	~600 (compared to ionic contrast agents)
Packaging	Vials (10 mL, 30 mL, 50 mL, 100 mL)
Approval & Regulations	Widely approved across US, EU, APAC

---

Current Market Landscape

Market Size and Growth Potential

As of 2022, the global contrast media market was valued at approximately $2.7 billion, with Iohexol representing around 45-55% market share among non-ionic contrast agents. The segment is driven by:

• Increasing prevalence of chronic and cardiovascular diseases
• Rising use of diagnostic imaging
• Growing adoption in emerging markets

Annual Growth Rate (CAGR):
Projected at 4-6% for 2022-2027, fueled by technological advances and expanding healthcare infrastructure.

Key Market Participants

Company	Product Name	Market Share	Geographical Focus
GE Healthcare	Omnipaque	~40%	Global, especially US, Europe
Bayer	Gadolinium, Isolex	~25%	Europe, North America
GE Healthcare	Gadoxetate Disodium	Minor	US, Japan
Others	Various	~15-20%	Asia-Pacific, LATAM

Market Drivers

• Aging Population: Increased demand for imaging in elderly
• Technological Innovations: Enhanced imaging modalities improve contrast agent efficacy
• Regulatory Approvals: Widespread approval facilitates market access
• Healthcare Expansion: Growth in outpatient diagnostics

Market Challenges

• Safety Concerns: Allergic reactions, NSF (Nephrogenic Systemic Fibrosis)
• Alternatives: Gadolinium-based agents, microbubble techniques
• Regulatory Scrutiny: Stringent approval processes in emerging markets
• Price Pressure: Increased competition leading to margin compression

---

Financial Trajectory and Revenue Projections

Historical Revenue Analysis (2018-2022)

Year	Total Market Revenue (USD Billion)	Iohexol Share (%)	Iohexol Revenue (USD Million)
2018	2.3	50%	1,150
2019	2.4	52%	1,248
2020	2.6	53%	1,378
2021	2.7	55%	1,485
2022	2.7	55%	1,485

Note: The stability indicates a mature market with incremental growth.

Projected Revenue (2023-2027)

Year	Expected Market Revenue (USD Billion)	Expected Iohexol Share (%)	Expected Iohexol Revenue (USD Million)
2023	2.8	55%	1,540
2024	3.0	54%	1,620
2025	3.2	54%	1,728
2026	3.4	54%	1,836
2027	3.6	53%	1,908

Assumptions: Steady adoption rates, minimal regulatory disruptions, moderate innovation impact.

Pricing Trends

• Slight decline (~1-2% annually) driven by increased competition and commoditization.
• Premium pricing in niche markets or for specialized formulations.

Profitability Outlook

• Gross margins: Estimated at 60-70%, depending on manufacturing efficiencies.
• R&D investment: Focused on formulations with improved safety/efficacy, possibly leading to higher margins.
• Regulatory compliance costs: Rising in emerging markets, affecting net margins.

---

Regulatory and Policy Influences

Global Regulatory Landscape

Region	Key Policies / Regulations	Impact on Iohexol
US	FDA approval for contrast agents, monographs, labeling standards	Ensures market stability and safety compliance
EU	EMA regulations, Medical Device Directives, MDRs	Stringent safety and efficacy standards
Japan	PMDA approvals, hospital licensing	Rapid adoption due to early market entry
Emerging Markets	Varying, often less stringent but increasing oversight	Potential barriers and opportunities

Recent Policy Developments (2020-2023)

• FDA Guidance (2021): Emphasized safety monitoring and adverse event reporting.
• EU MDR (2017/745): Implemented stricter assessment criteria impacting labeling and post-market surveillance.
• Developing Countries: Growing push towards compliance with WHO standards, influencing imports and local manufacturing.

---

Competitive Landscape & Innovation Trends

Company	Key Strategies	Recent Innovations
GE Healthcare	Product diversification, regional expansion	Lower osmolality formulations
Bayer	Mergers, pipeline enhancement	New formulations with reduced adverse effects
Bracco	Focus on Asia-Pacific markets	Aquason (hydrodissection contrast)
Guerbet	Digital marketing, contract manufacturing	Multi-purpose contrast agents

Emerging Trends

• Low-/Iso-osmolar Agents: Increasing preference for safer formulations.
• Nanoparticle Conjugates: Potential to improve imaging resolution.
• Digital Integration: Tracking contrast usage and adverse events via EHR integration.
• Generic Consolidation: Price competitiveness driven by biosimilar and generic entrants.

---

Future Growth Drivers and Barriers

Growth Opportunities

• Expansion into underserved markets (Africa, Southeast Asia).
• Integration with AI for dose optimization.
• Development of reduced-dose or allergy-free formulations.
• Strategic acquisitions and licensing deals.

Potential Barriers

• Regulatory delays and compliance costs.
• Price wars diminishing profit margins.
• Competition from alternative imaging contrast agents.
• Safety concerns leading to usage restrictions.

---

Comparison with Alternative Diagnostic Contrasts

Attribute	Iohexol	Gadolinium-based Agents	Microbubbles
Safety Profile	High, fewer allergic reactions	Related to NSF concerns	Very safe but limited to ultrasonography
Imaging Scope	CT, angiography	MRI	Ultrasound
Cost	Moderate	Slightly higher	Variable
Regulatory Acceptance	Widespread	Widespread	Emerging
Usage in Patients with Renal Impairment	Safe	Cautiously used (risk of NSF)	Safe

---

Key Takeaways

1. Steady Market Demand: Iohexol retains a dominant position in contrast media, with an expected CAGR of 4-6% through 2027.
2. Pricing and Competition: Marginal price declines are expected, emphasizing efficiency and differentiation.
3. Regulatory Tightening: Stricter policies, especially in developed markets, require ongoing compliance investments.
4. Innovative Potential: Advances towards lower osmolality and allergen-free formulations could expand use cases.
5. Expansion in Emerging Markets: Untapped growth opportunities exist but require navigating regulatory and economic hurdles.

---

FAQs

Q1: What factors most influence Iohexol's market growth?
Demand primarily hinges on increasing imaging procedures, technological integration, regulatory approvals, and healthcare infrastructure expansion, especially in emerging markets.

Q2: How are safety concerns impacting Iohexol's market share?
While safer than ionic contrast agents, concerns over allergic reactions and contrast-induced nephropathy have prompted formulation improvements and cautious clinical use, but overall demand remains stable due to efficacy.

Q3: What are the main competitive threats to Iohexol?
Alternatives include gadolinium-based agents for MRI, microbubbles for ultrasound, and emerging nanoparticle contrast agents; regulatory and safety issues could accelerate shifts.

Q4: Which regions offer the most growth potential?
Emerging markets in Asia-Pacific, Africa, and Latin America become attractive due to rising healthcare access, though regulatory complexities remain.

Q5: How might technological innovations impact future revenues?
Innovations such as low-osmolality formulations, allergen-free agents, and digitally integrated contrast management have the potential to increase safety and expand applications, positively influencing revenues.

---

Citations

1. Grand View Research. (2022). Contrast Media Market Size, Share & Trends Analysis.
2. FDA. (2021). Guidance for Industry: Contrast Agents Safety.
3. European Medicines Agency. (2019). Assessment Reports on Iodinated Contrast Agents.
4. MarketWatch. (2022). Contrast Media Market Forecasts.
5. WHO. (2021). Guidelines on Medical Diagnostics and Imaging.

---

In conclusion, Iohexol remains a pillar within diagnostic imaging contrast markets, supporting ongoing healthcare advancements. Its financial trajectory remains favorable, bolstered by technological innovations, regulatory stability in mature markets, and expanding demand in emerging economies. Stakeholders should monitor evolving safety profiles, competitive movements, and regulatory policies to optimize investment and strategic positioning.