IOHEXOL Drug Patent Profile

« Back to Dashboard

Which patents cover Iohexol, and when can generic versions of Iohexol launch?

Iohexol is a drug marketed by Amneal and is included in one NDA.

The generic ingredient in IOHEXOL is iohexol. There is one drug master file entry for this compound. Four suppliers are listed for this compound. Additional details are available on the iohexol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iohexol

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

Summary for IOHEXOL

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	75
Patent Applications:	4,330
DailyMed Link:	IOHEXOL at DailyMed

Recent Clinical Trials for IOHEXOL

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

Sponsor	Phase
University Hospital, Tours	NA
MediBeacon	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

IOHEXOL is protected by zero US patents and one FDA Regulatory Exclusivity.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Amneal	IOHEXOL	iohexol	SOLUTION;INJECTION, ORAL	217737-002	Jun 25, 2026	AP	RX	No	No
Amneal	IOHEXOL	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	217737-001	Nov 13, 2025	AP	RX	No	No

Iohexol Market Dynamics, Financial Trajectory, Patent Status, and Competitive Outlook

Last updated: October 24, 2026

Iohexol is a mature, off-patent iodinated contrast medium sold primarily as GE HealthCare’s Omnipaque. Its market is driven by CT and angiographic procedure volumes rather than prescription growth. The product has limited direct patent protection, intense hospital-contract competition, and meaningful manufacturing and supply-chain risk. GE HealthCare does not separately disclose Omnipaque revenue, so financial analysis relies on its Pharmaceutical Diagnostics segment as the closest public proxy.

What is iohexol and how is it used?

Iohexol is a nonionic, low-osmolar iodinated contrast agent administered for X-ray-based imaging. Its principal uses include:

• Contrast-enhanced computed tomography
• CT angiography
• Digital subtraction angiography
• Intra-arterial angiography
• Intravenous urography
• Pediatric imaging
• Certain body-cavity examinations

Omnipaque is approved in multiple concentrations, including formulations containing 140, 180, 240, 300 and 350 mg of organically bound iodine per milliliter, depending on the indication and route of administration (U.S. Food and Drug Administration [FDA], 2023).

Unlike many specialty drugs, iohexol is purchased mainly by hospitals, imaging centers and radiology departments. Procurement is influenced by contract price, supply reliability, concentration range, injector compatibility, clinical familiarity and reimbursement economics.

Who manufactures and markets iohexol?

GE HealthCare is the principal global commercial company associated with iohexol through the Omnipaque brand. The business originated in GE’s medical-imaging and pharmaceutical-diagnostics operations and became part of GE HealthCare after its 2023 separation from General Electric.

The competitive market includes branded and generic suppliers of iohexol and competing iodinated contrast agents.

Company	Product or active ingredient	Market position
GE HealthCare	Omnipaque, iohexol	Major branded iohexol supplier
Bracco	Isovue, iopamidol	Major low-osmolar contrast competitor
Guerbet	Iopromide, other contrast agents	Global imaging-contrast supplier
Bayer	Ultravist, iopromide	Global branded competitor
United Imaging and regional suppliers	Various iodinated agents	Increasing regional and tender-based competition
Generic manufacturers	Iohexol and other iodinated agents	Price-based competition, subject to regulatory approval and supply capacity

Iohexol competes primarily with iopamidol, iopromide, ioversol and iodixanol. Clinical substitution is possible in many CT applications, but hospital protocols, injector systems, tender awards and physician familiarity can slow switching.

What is the financial trajectory for iohexol?

GE HealthCare does not report Omnipaque sales as a separate line item. Its Pharmaceutical Diagnostics segment is the relevant public financial proxy because it includes contrast media and radiopharmaceutical products.

Financial metric	Publicly reported position
Product-level Omnipaque revenue	Not separately disclosed
Relevant reporting segment	GE HealthCare Pharmaceutical Diagnostics
2023 GE HealthCare total revenue	Approximately $19.6 billion
2023 Pharmaceutical Diagnostics revenue	Approximately $4.9 billion
Primary growth drivers	Imaging procedure volumes, radiopharmaceutical demand, pricing and product mix
Main constraints	Hospital purchasing pressure, supply interruptions, manufacturing costs and currency effects

The segment’s trajectory has benefited from recurring demand for imaging agents and the continued use of CT in oncology, cardiovascular care, emergency medicine and general diagnostics. Iohexol is a mature product, so volume growth is more likely to track imaging utilization than to produce pharmaceutical-style growth rates.

The commercial profile is comparatively defensive. A contrast agent is consumed repeatedly with procedures, and established products can retain substantial hospital use after patent expiry. The trade-off is low differentiation and strong price competition. Financial performance depends more on manufacturing scale, supply reliability and contract retention than on exclusivity-based pricing.

How large is the iohexol market?

Public companies generally do not disclose global iohexol sales. Published market research often combines several iodinated contrast agents or reports the entire contrast-media market, making product-specific estimates inconsistent.

The addressable market is supported by:

1. Growth in CT procedures and CT angiography.
2. Expansion of diagnostic imaging in emerging markets.
3. Aging populations and higher chronic-disease prevalence.
4. Increased cancer screening and cardiovascular imaging.
5. Replacement of some older high-osmolar agents with low-osmolar products.

Growth is moderated by:

• Generic and multi-source competition
• Hospital group purchasing organization negotiations
• Dose optimization and lower-volume imaging protocols
• Substitution among nonionic iodinated agents
• Periodic procedure deferrals caused by staffing or equipment constraints
• Manufacturing concentration among a limited number of specialized facilities

Iohexol is therefore a high-volume, low-growth pharmaceutical product. The market can expand in value through procedure growth and price increases, but product-level revenue is vulnerable to tender losses and generic discounting.

When does iohexol lose exclusivity?

Iohexol has no meaningful current composition-of-matter exclusivity in the United States. Its original patents and regulatory exclusivity periods expired many years ago.

The FDA approved Omnipaque in 1985. The product is now a mature, multi-source contrast agent, and commercial barriers arise mainly from manufacturing, regulatory compliance, quality history and distribution capacity rather than from patent protection (FDA, 2023).

Iohexol’s principal exclusivity status is summarized below.

Protection category	Current position
Composition-of-matter patent	Expired
Original product patent protection	Expired
New chemical entity exclusivity	Expired
Orphan-drug exclusivity	Not applicable
Biosimilar exclusivity	Not applicable
Current U.S. market exclusivity	None identified
Primary commercial barrier	Scale, quality, supply and hospital contracts

What is the Orange Book status of iohexol?

The Orange Book is primarily relevant to FDA-approved drug products with patent and exclusivity information. Iohexol’s commercial products are approved legacy contrast agents, and no active patent-based exclusivity comparable to that of a recently launched branded drug is central to the market.

Omnipaque’s regulatory protection is not the principal reason for continued sales. The product remains commercially relevant because it is approved across a broad range of concentrations and indications, is integrated into radiology workflows and has an established supply network.

A patent listing, if present for a particular approved presentation or use, would not by itself recreate meaningful market exclusivity for the underlying iohexol molecule. Generic competition and therapeutic substitution remain available.

Are there Paragraph IV challenges to Omnipaque?

Paragraph IV litigation is not a major current market feature for iohexol. The relevant patents protecting the underlying active ingredient expired long ago, and the market is already exposed to generic and competing contrast agents.

For a mature product such as iohexol, competitive entry is more likely to occur through:

• Abbreviated New Drug Application approvals
• Contract manufacturing arrangements
• Regional tenders
• Hospital formulary substitution
• Supply-based share gains during shortages

This differs from a newly launched small-molecule drug, where an ANDA filing accompanied by a Paragraph IV certification can trigger Hatch-Waxman litigation and a 30-month stay. For Omnipaque, the commercial question is generally whether a supplier can obtain approval, meet quality standards and deliver at scale.

What formulations are protected by iohexol patents?

Current commercial differentiation is based primarily on concentration, presentation and manufacturing controls rather than active patent exclusivity.

Omnipaque is supplied in several iodine concentrations and container formats. Products can be sold in bottles, prefilled syringes, polymer containers and other hospital-use configurations, depending on market and approval status. Relevant technical barriers include:

• Consistent iodine concentration
• Low particulate levels
• Sterility assurance
• Stability over the approved shelf life
• Container-closure integrity
• Compatibility with automated injectors
• Reliable production at high batch volumes

Formulation and device patents may cover particular packaging systems, injector interfaces or manufacturing processes. Such rights would generally be narrower than the expired rights covering iohexol as an active pharmaceutical ingredient. They do not create broad protection against all iohexol products.

How strong is the patent estate for iohexol?

The patent estate is weak as a current exclusivity asset and strong only as a historical development asset.

Patent-estate factor	Assessment
Active ingredient protection	Expired
Product lifecycle protection	Limited
Method-of-use protection	Limited commercial impact
Formulation protection	Potentially narrow and presentation-specific
Manufacturing know-how	More relevant than issued patents
Regulatory barriers	Moderate
Supply-chain barriers	Material
Litigation leverage	Low

Manufacturing know-how may include crystallization, impurity control, sterilization, filling, inspection and quality-release procedures. These capabilities can delay entry even when patents are expired. They do not provide the same legal exclusivity as a valid composition patent.

What patent litigation affects iohexol?

No major current U.S. patent dispute appears to define the iohexol market. Litigation risk is more likely to involve:

• Product liability
• Contrast-reaction claims
• Manufacturing quality
• Supply agreements
• Procurement disputes
• Regulatory compliance
• Intellectual property involving delivery devices or packaging

The absence of major patent litigation is consistent with iohexol’s age and multi-source status. Any dispute involving a narrow formulation or device claim would be unlikely to restore molecule-level exclusivity.

What supply-chain risks affect iohexol?

Supply reliability is one of the largest commercial variables. In 2022, GE HealthCare reported a disruption involving its contrast-media manufacturing facility in Shanghai after a lockdown. The disruption affected global supply of iodinated contrast media, including Omnipaque, and forced hospitals to ration products, delay imaging or use alternative agents (GE HealthCare, 2022).

The episode demonstrated several market characteristics:

• Production is concentrated in specialized facilities.
• Hospitals often maintain limited inventory because contrast media have defined shelf lives.
• Shortages can shift demand rapidly to competitors.
• Regulatory approval does not guarantee immediate substitute availability.
• Manufacturing resilience can create greater commercial value than patent ownership.

China remains important to the global contrast-media supply chain, including production of active ingredients and finished products. Geographic diversification, dual sourcing and inventory planning are likely to remain procurement priorities.

How does iohexol compare with iodixanol and other contrast agents?

Attribute	Iohexol	Iodixanol	Iopamidol	Iopromide
Osmolality class	Low-osmolar	Iso-osmolar	Low-osmolar	Low-osmolar
Representative brand	Omnipaque	Visipaque	Isovue	Ultravist
Primary buyer	Hospitals and imaging centers	Hospitals and imaging centers	Hospitals and imaging centers	Hospitals and imaging centers
Patent status	Mature, expired	Mature, largely expired	Mature, largely expired	Mature, largely expired
Differentiation	Concentration range, familiarity, supply	Iso-osmolar profile	Clinical familiarity and contracts	Brand, supply and contracts
Main competitive lever	Price and availability	Clinical positioning and price	Contract economics	Contract economics

Iodixanol can receive preference in selected patients or protocols because it is iso-osmolar, but its higher acquisition cost can limit broad substitution. Iohexol remains competitive because it has extensive clinical use, multiple concentrations and established workflow integration.

What is the FDA regulatory status of Omnipaque?

Omnipaque is an FDA-approved prescription contrast agent. Its approved labeling covers multiple diagnostic imaging uses and concentrations. The FDA label includes warnings related to hypersensitivity reactions, renal risk, extravasation and other administration-related complications (FDA, 2023).

The regulatory profile is mature. Future commercial growth does not depend on a new indication comparable to a therapeutic drug launch. Regulatory priorities are more likely to involve:

• Manufacturing-site changes
• Supplemental applications
• Container and presentation changes
• Label updates
• Quality compliance
• Shortage mitigation

What licensing deals affect iohexol?

No major recent licensing transaction appears to be the central driver of iohexol’s market. The product is commercially controlled through GE HealthCare’s pharmaceutical-diagnostics business and established distribution relationships.

Licensing or supply arrangements may exist at regional levels, but public disclosure is limited. The most consequential commercial agreements are likely hospital contracts, distributor arrangements, government tenders and group purchasing agreements rather than molecule-level licenses.

What generic launch scenarios exist for iohexol?

The most likely competitive scenarios are:

Scenario	Market effect
Additional generic suppliers enter	Lower contract prices and share pressure for Omnipaque
GE maintains supply reliability	Brand retention despite expired patents
New shortage occurs	Temporary share shifts to iopamidol, iopromide, ioversol or iodixanol
Hospital systems consolidate purchasing	Greater price pressure and fewer winning suppliers
CT procedure growth accelerates	Higher total contrast demand
Manufacturing costs rise	Margin pressure unless contracts permit price adjustments

A generic launch would not need to overcome a strong patent barrier. It would need to meet FDA quality requirements, demonstrate pharmaceutical equivalence where applicable, establish reliable sterile production and secure distribution capacity.

What revenue exposure does iohexol create for GE HealthCare?

Omnipaque is strategically important within Pharmaceutical Diagnostics but is not separately material in public financial reporting. The product contributes recurring revenue, customer retention and portfolio breadth. Its individual margin profile is affected by:

• Active pharmaceutical ingredient costs
• Sterile filling capacity
• Freight and logistics
• Packaging costs
• Hospital pricing
• Product mix by iodine concentration
• Shortage-related production inefficiencies

The product’s revenue trajectory is likely to be stable to modestly growing over the long term, with episodic volatility during supply disruptions. It is unlikely to produce high pharmaceutical-style growth without a significant increase in global imaging volumes or a structural supply advantage.

Key Takeaways

• Iohexol is a mature, off-patent iodinated contrast medium sold primarily as Omnipaque by GE HealthCare.
• No current composition patent or regulatory exclusivity drives the product’s market position.
• Omnipaque revenue is not separately disclosed; GE HealthCare’s Pharmaceutical Diagnostics segment is the best public financial proxy.
• Demand follows CT and angiography procedure volumes, not conventional prescription-drug adoption.
• Hospital tenders, generic competition and supply reliability determine market share.
• The 2022 Shanghai manufacturing disruption showed that supply-chain concentration is a material commercial risk.
• Paragraph IV litigation and biosimilar competition are not central to iohexol.
• Manufacturing scale, sterility, quality systems and distribution capacity are more important barriers than patents.
• The financial outlook is stable but mature, with upside from imaging growth and downside from price erosion or supply interruptions.

FAQs

Is iohexol a generic drug?

Iohexol is an active pharmaceutical ingredient used in both branded and generic contrast products. Omnipaque is the principal branded reference product, but the underlying molecule is off patent.

Is Omnipaque still protected by patents?

The original patents covering iohexol and its core product technology expired years ago. Narrow patents covering packaging, delivery systems or manufacturing processes may exist, but they do not provide broad molecule-level exclusivity.

Can hospitals substitute iodixanol for iohexol?

Hospitals can use iodixanol or other iodinated contrast agents in appropriate clinical settings, subject to physician judgment, product labeling, patient factors and institutional protocols.

Does iohexol have biosimilar competition?

No. Biosimilar regulation applies to biological products. Iohexol is a chemically synthesized small molecule and competes with generic and therapeutically substitutable contrast agents.

What is the main investment risk for an iohexol supplier?

The principal risks are price compression, hospital-contract losses, manufacturing disruption, regulatory quality problems and substitution by competing iodinated contrast media.

References

1. GE HealthCare Technologies Inc. (2024). 2023 annual report. GE HealthCare.

2. GE HealthCare. (2022, May 24). GE Healthcare provides update on contrast media supply. GE HealthCare.

3. U.S. Food and Drug Administration. (2023). Omnipaque (iohexol injection) prescribing information. FDA.

4. U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. FDA.

5. U.S. Food and Drug Administration. (2024). Drug shortages: Iohexol injection and iodinated contrast media. FDA.