Last Updated: May 10, 2026

Iohexol - Generic Drug Details


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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. Four 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: 4
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

SponsorPhase
University Hospital, ToursNA
MediBeaconNA
University Hospitals Cleveland Medical CenterNA

See all iohexol clinical trials

Pharmacology for iohexol
Medical Subject Heading (MeSH) Categories for iohexol

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 12 iohexol SOLUTION;ORAL 018956-009 Apr 17, 2018 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 020608-003 Oct 24, 1995 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Interpharma Praha As ORALTAG iohexol FOR SOLUTION;ORAL 205383-001 Mar 26, 2015 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare OMNIPAQUE 240 iohexol SOLUTION;INJECTION, ORAL, RECTAL 018956-002 Dec 26, 1985 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for iohexol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare OMNIPAQUE 180 iohexol SOLUTION;INJECTION, ORAL, RECTAL 018956-001 Dec 26, 1985 4,021,481 ⤷  Start Trial
Ge Healthcare OMNIPAQUE 140 iohexol INJECTABLE;INJECTION 018956-005 Nov 30, 1988 4,396,597 ⤷  Start Trial
Ge Healthcare OMNIPAQUE 140 iohexol INJECTABLE;INJECTION 018956-005 Nov 30, 1988 4,021,481 ⤷  Start Trial
Ge Healthcare OMNIPAQUE 240 iohexol SOLUTION;INJECTION, ORAL, RECTAL 018956-002 Dec 26, 1985 4,021,481 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Iohexol Market Analysis and Financial Projection

Last updated: April 24, 2026

Market dynamics and financial trajectory for IOHEXOL

What is the market position of iohexol across imaging indications?

Iohexol is a non-ionic, low-osmolality iodinated contrast medium (ICM) used for X-ray based imaging, including computed tomography (CT) and angiography. It is typically marketed as a diagnostic imaging agent and competes primarily within the iodinated contrast segment rather than across non-iodinated modalities.

Primary commercial use-cases (revenue pools)

  • CT contrast enhancement (high-frequency diagnostic imaging driver)
  • Angiography and vascular imaging (lower volume, higher unit value where used)
  • Other radiographic applications where iodinated contrast remains standard of care

Core competitive set

  • Branded and generic iodinated low-osmolality contrast agents (class-level substitution is common once originator exclusivity expires)
  • Differentiation in practice centers on formulation attributes (viscosity, concentration offerings), supply reliability, and pricing rather than unique clinical outcomes

Formulation and concentration breadth Iohexol is widely sold in multiple concentrations and pack formats, which improves formulary inclusion. The commercial impact is practical: hospitals can standardize on a limited number of SKUs while adjusting concentration by indication.


How do patent status and generic entry shape pricing and revenue?

Iohexol is an established molecule with broad generic availability in most markets. In liquid contrast-agent markets, generic entry typically compresses gross margins quickly and shifts long-term revenue toward distributors, tender wins, and contract manufacturing scale.

Generic-driven market behavior

  • Price compression after exclusivity loss: ICMs are frequently tendered; procurement rules favor lowest total cost for equivalent dosing and concentration.
  • Formulary churn limits pricing power: Once a generic is accepted, physicians often lack a switching incentive because imaging quality is largely similar across low-osmolality products at the same iodine dose.
  • Concentration coverage drives share stability: Manufacturers with full concentration and pack portfolios hold formulary position even when base prices fall.

Commercial implication Iohexol’s long-run financial trajectory is typically characterized by:

  • High baseline adoption early
  • A step-down in pricing after generic erosion
  • A subsequent stabilization where volume and contract wins determine revenue, not innovation differentiation

What are the demand drivers for iohexol volumes and use intensity?

Demand for iodinated contrast is tied to imaging utilization and clinical pathways rather than to adherence or long-term dosing behaviors.

Key demand drivers

  • CT utilization growth in outpatient and emergency settings
  • Cardiovascular imaging volumes (interventional and diagnostic)
  • Hospital procurement cycles that lock usage to tender awarded product(s)
  • Supply chain resiliency and scale that reduce stockout risk and preserve administered volumes

Where demand is structurally resilient

  • Emergency imaging workflows where contrast is integral and substitution is routine once approved products exist
  • Routine CT protocols across oncology, neurologic, and abdominal indications

How do regulatory and pharmacovigilance dynamics affect commercialization?

For established ICMs, ongoing commercialization depends less on de novo approvals and more on manufacturing compliance, lot consistency, and signal management.

Operational regulatory effects

  • Manufacturing and quality system adherence are the main gating factors for continued supply into major hospital and national formularies.
  • Post-marketing safety communications can affect prescribing preference, but for class-wide agents they typically do not reverse adoption unless risk mitigation changes standard practice.

Commercial implication For iohexol, the financial trajectory usually tracks operational execution and procurement outcomes rather than novel label expansion.


How does substitution risk play out versus alternative contrast agents?

Iohexol competes mainly with other iodinated contrast media and only secondarily with non-iodinated modalities.

Substitution within iodinated low-osmolality ICM

  • Hospitals generally select based on total cost, concentration availability, viscosity handling, and supply reliability.
  • Clinical differences between low-osmolality agents are often marginal for routine imaging when iodine dose is maintained.

Non-iodinated and alternative modality pressures

  • MRI and contrast-enhanced ultrasound can substitute in select pathways, but CT remains dominant for many urgent and anatomical imaging workflows.
  • For most CT angiography and many CT contrast-enhanced indications, iodinated contrast stays standard.

What does the financial trajectory typically look like for iohexol as a matured molecule?

Given iohexol’s maturity and generic penetration, the financial profile generally follows a pattern common to off-patent small-molecule branded-to-generic transitions in hospital-administered commodities.

Trajectory profile

  1. Early growth during brand exclusivity (pricing power and stable margins)
  2. Rapid margin compression after generic launches
  3. Revenue stabilization by volume and contracts as supply scale and procurement wins dominate
  4. Ongoing erosion in high-price geographies until tender cycles saturate

Where profitability concentrates

  • Contract manufacturing scale
  • Logistics and inventory optimization
  • Maintaining acceptance across formularies through consistent product performance

Market structure and sales mechanics

Who buys

  • Hospital systems, imaging centers, and procurement consortia
  • Public and private tender authorities

How revenue is made

  • Multi-year or recurring procurement contracts
  • Conversion of new sites during tender cycles
  • SKU and concentration coverage that supports protocol standardization

Why product form matters

  • Pack sizes and concentration flexibility reduce protocol friction
  • Viscosity handling impacts workflow preferences in certain clinical settings, even when clinical outcomes are similar

What are the main headwinds and tailwinds for the next phase of demand?

Headwinds

  • Ongoing generic price competition
  • Tender pricing pressure from procurement consolidation
  • Manufacturing disruptions risk lost contract share and bid competitiveness

Tailwinds

  • CT volume growth
  • Expanding indications where CT contrast remains standard
  • Manufacturers with resilient supply chains winning repeat tender cycles

How should businesses underwrite long-term iohexol commercial outcomes?

Investment and R&D lens

  • For new entrants, upside is limited by commoditization; differentiation must be operational (supply, cost, regulatory readiness) or formulation-level (handling, concentration design) with clear procurement value.
  • For existing manufacturers, the strategy should focus on maintaining contract coverage and minimizing quality and supply variance.

Commercial underwriting

  • Model revenue primarily from imaging utilization growth and tender retention rather than price growth.
  • Treat pricing as mean-reverting downward under competitive tenders.

Key Takeaways

  • Iohexol competes primarily within the iodinated low-osmolality contrast market and is driven by CT and vascular imaging utilization rather than new clinical paradigms.
  • Generic availability and tender-based procurement drive sustained price compression and shift value toward volume, contract wins, and reliable supply.
  • Financial trajectory for iohexol is structurally typical of matured hospital-administered commodities: early branded growth, margin erosion after generic entry, then stabilization led by procurement coverage.

FAQs

1) Is iohexol revenue growth likely to come from higher pricing or higher volume?

Volume is the dominant lever once generic competition is entrenched; pricing typically trends down through tender cycles.

2) What imaging modalities most determine iohexol demand?

CT contrast enhancement and vascular imaging are the main demand pools tied to iodinated contrast use.

3) How does tendering affect manufacturer profitability?

Tendering concentrates purchases among awarded suppliers and pushes pricing toward the lowest acceptable total cost for equivalent concentration and dosing.

4) What differentiation tends to matter most for iohexol in hospital procurement?

Operational reliability, concentration and pack availability, and handling attributes that reduce workflow friction.

5) Does iohexol face direct displacement from non-iodinated imaging agents?

Displacement is selective; for many CT indications, iodinated contrast remains standard, limiting modal substitution.


References

[1] European Medicines Agency. IOHEXOL-containing medicinal products: summary of product characteristics and regulatory information. EMA website. https://www.ema.europa.eu/
[2] U.S. Food and Drug Administration. Drug safety communications and labeling resources for iodinated contrast media (class information). FDA website. https://www.fda.gov/
[3] Gold Standard Company and drug database resources. Iohexol market and product listings (concentration and formulation breadth). https://www.drugs.com/

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