Last updated: September 8, 2026
Iothalamate meglumine is a mature, low-growth iodinated contrast medium used primarily for radiographic imaging and angiography. Its commercial profile is driven by hospital procurement, product availability, procedure volumes, and manufacturing economics rather than patent exclusivity. Conray is the principal branded product associated with iothalamate meglumine in the United States. Public filings do not disclose standalone revenue for iothalamate meglumine, so its financial trajectory must be assessed through market maturity, competitive substitution, pricing, and supply conditions.
What is the current market position of iothalamate meglumine?
Iothalamate meglumine is an ionic, high-osmolar iodinated contrast agent. It competes with nonionic low-osmolar agents such as iohexol, iopamidol, ioversol, and ioxilan, as well as other ionic contrast products.
The product is used for:
- Angiography
- Cerebral and peripheral arteriography
- Intravenous digital subtraction angiography
- Computed tomography in selected applications
- Intravenous excretory urography
- Contrast enhancement in radiographic procedures
Conray products are supplied in multiple concentrations, including formulations identified as Conray 30, Conray 43, Conray 60, and Conray 66. Product availability and labeling vary by jurisdiction and presentation. U.S. labeling identifies iothalamate meglumine as the active contrast component in these formulations.[1]
| Market attribute |
Iothalamate meglumine position |
| Therapeutic class |
Iodinated radiographic contrast medium |
| Molecular type |
Small-molecule ionic contrast agent |
| Principal U.S. brand |
Conray |
| Primary customer |
Hospitals, imaging centers, radiology departments |
| Regulatory status |
Approved prescription injectable product |
| Patent dependence |
Low; core composition patents are long expired |
| Generic exposure |
High |
| Biosimilar exposure |
None |
| Growth profile |
Mature to declining in developed markets |
| Revenue disclosure |
No standalone public reporting identified |
When does iothalamate meglumine lose exclusivity?
Iothalamate meglumine lost meaningful market exclusivity decades ago. The active ingredient and conventional injectable formulations are legacy products, and any original composition, formulation, or use patents would have expired long before the current commercial period.
The commercial protection remaining today is generally limited to:
- Manufacturing know-how
- Supplier relationships
- Product-specific regulatory files
- Packaging and presentation
- Brand recognition
- Institutional contracts
- Distribution reliability
Unlike a recently approved small molecule, iothalamate meglumine does not have a commercially relevant patent cliff ahead. The relevant economic question is whether a supplier can manufacture and distribute the product at an acceptable margin.
Are there active Orange Book patents for iothalamate meglumine?
The FDA Orange Book is the principal U.S. source for listed patents and regulatory exclusivity associated with approved drug products. Legacy contrast agents such as Conray are not generally protected by active, commercially meaningful patents covering the core iothalamate meglumine product.[2]
The Orange Book framework is less important for this product than it is for modern branded drugs because:
- The underlying active ingredient is old.
- The principal injectable presentations have been marketed for many years.
- Competition is based on procurement price, supply continuity, formulation characteristics, and clinical familiarity.
- No current patent-based delay to generic entry is expected to define the market.
What is the FDA regulatory status of iothalamate meglumine?
Iothalamate meglumine remains an FDA-approved injectable contrast medium, subject to prescription-drug manufacturing, labeling, quality, and adverse-event requirements. Its regulatory value is tied to continued compliance with current good manufacturing practice and maintenance of approved product specifications.
FDA-approved labeling identifies established risks associated with iodinated contrast media, including hypersensitivity reactions, renal adverse events, cardiovascular effects, and extravasation-related injury.[1]
The regulatory burden is operational rather than exclusivity-based. A manufacturer must maintain:
- Validated sterile manufacturing
- Consistent iodine concentration
- Control of particulate and endotoxin levels
- Container-closure integrity
- Stability data
- Accurate dosing and administration instructions
- Pharmacovigilance systems
For a legacy contrast agent, a manufacturing failure can have a greater commercial impact than a patent challenge.
What patents protect iothalamate meglumine?
No active patent category is likely to provide broad protection for the legacy iothalamate meglumine molecule itself. Any remaining intellectual-property protection would more likely concern a narrow manufacturing process, a delivery presentation, a device, or a proprietary packaging configuration.
| Potential IP category |
Commercial relevance |
| Active ingredient composition |
Minimal; legacy protection expired |
| Basic injectable formulation |
Minimal; long-established technology |
| Concentration-specific presentation |
Usually regulatory and commercial, not patent-driven |
| Manufacturing process |
Possible narrow protection, but difficult to assess publicly |
| Container or delivery system |
Potentially relevant for a specific presentation |
| Method of use |
Limited value for established diagnostic procedures |
| Trademark |
Can protect Conray branding but not the active ingredient |
Method-of-use patents are also unlikely to create a material barrier. The principal uses of iothalamate meglumine are established radiographic procedures rather than newly discovered therapeutic indications.
How many patents cover iothalamate meglumine?
There is no commercially meaningful active patent estate comparable to the estate surrounding a recently launched pharmaceutical. The number of historical patents associated with iothalamate chemistry or contrast-agent manufacturing may be greater than the number of patents currently enforceable against competitors.
Patent-count analysis should therefore distinguish between:
- Historical patents that have expired
- Patents covering unrelated iodinated contrast compounds
- Narrow process patents
- Device or packaging patents
- Current, enforceable claims that could block commercial entry
For iothalamate meglumine, the relevant answer is that patent protection does not materially control market access.
Which companies compete with iothalamate meglumine?
Iothalamate meglumine competes primarily with other iodinated contrast media rather than with products containing the same active ingredient.
| Competitor |
Active ingredient |
Competitive position |
| Omnipaque |
Iohexol |
Broad hospital and imaging-center use; nonionic, low-osmolar |
| Isovue |
Iopamidol |
Major nonionic low-osmolar competitor |
| Optiray |
Ioversol |
Established nonionic contrast product |
| Visipaque |
Iodixanol |
Iso-osmolar product with differentiated renal-risk positioning |
| Ultravist |
Iopromide |
Internationally significant nonionic competitor |
| Hexabrix, where available |
Ioxaglate |
Ionic low-osmolar contrast agent in selected markets |
| Conray |
Iothalamate meglumine |
Legacy ionic, high-osmolar product |
The principal competitive disadvantage is clinical preference for nonionic low-osmolar or iso-osmolar agents in many modern imaging settings. These products generally have higher acquisition costs but may be favored because of tolerability, institutional protocols, and clinical practice standards.
What drives the financial trajectory of iothalamate meglumine?
The financial trajectory is likely mature, stable to declining in volume, and exposed to price pressure. Public companies do not generally report iothalamate meglumine revenue as a separate line item, preventing a reliable product-level sales estimate.
Revenue drivers
The main revenue drivers are:
- Number of angiographic and radiographic procedures
- Hospital formulary status
- Contract pricing
- Availability of competing contrast agents
- Supply reliability
- Product concentration and vial configuration
- Regional use patterns
- Distributor inventories
- Manufacturing costs for sterile injectable products
Margin drivers
Margins depend on:
- Raw material costs
- Iodine-related input costs
- Sterile filling capacity
- Quality-control requirements
- Freight and cold-chain or controlled-storage requirements, where applicable
- Batch size
- Product withdrawals and waste
- Hospital purchasing concessions
- Regulatory compliance costs
The product can remain commercially viable at modest revenue levels if manufacturing infrastructure is established and fixed costs are controlled. The same product can become uneconomic if batch volumes fall, quality events increase, or hospitals shift permanently to nonionic alternatives.
Is iothalamate meglumine affected by FDA drug shortages?
Contrast-media markets are vulnerable to supply interruptions because production depends on specialized sterile facilities, iodine inputs, validated manufacturing lines, and limited qualified suppliers. The 2022 Shanghai manufacturing disruption affecting iodinated contrast supply demonstrated the sensitivity of global imaging operations to concentrated production networks.[3]
A shortage of a competing nonionic product can temporarily increase demand for legacy agents such as iothalamate meglumine. That effect is usually episodic rather than structural. Once supply normalizes, hospitals may return to preferred formulary products.
The commercial value of iothalamate meglumine can therefore rise during shortage periods without indicating durable market expansion.
What is the generic entry risk for iothalamate meglumine?
Generic entry risk is already realized rather than prospective. The product has no meaningful future patent cliff. A new entrant would face regulatory and manufacturing requirements, but not a high-value patent barrier.
The main entry barriers are:
- Demonstrating pharmaceutical equivalence
- Establishing sterile injectable manufacturing
- Sourcing qualified iodine-containing materials
- Validating container-closure systems
- Securing FDA approval for each presentation
- Building hospital and distributor relationships
- Competing against established contrast-agent suppliers
A generic entrant could pressure price, but the market may not support numerous suppliers because demand is mature and hospital contracts are price-sensitive.
What is the risk from Paragraph IV challenges?
Paragraph IV litigation is unlikely to be a central issue for legacy iothalamate meglumine products. Paragraph IV certifications are most consequential when an ANDA applicant challenges unexpired patents listed for a branded reference product. With no apparent active patent estate controlling the core product, generic competition is more likely to proceed through ordinary regulatory and commercial channels.
Does iothalamate meglumine face biosimilar competition?
No. Iothalamate meglumine is a chemically defined small molecule, not a biologic. It is regulated through the conventional drug approval pathway rather than the biosimilar pathway under section 351(k) of the Public Health Service Act.
Its relevant competition is from:
- Generic small-molecule contrast agents
- Branded nonionic contrast agents
- Hospital-compounded or institutionally sourced alternatives, where legally and operationally applicable
- Product substitutions during shortages
What litigation and licensing deals affect iothalamate meglumine?
No major current patent litigation or licensing transaction appears to define the commercial outlook for iothalamate meglumine. The market is more affected by corporate ownership, product transfers, manufacturing arrangements, and distribution contracts than by patent settlements.
For diligence purposes, relevant transaction risks include:
- Transfer of an approved product application
- Outsourcing of sterile manufacturing
- Change in contract manufacturing organization
- Distributor termination
- Product discontinuation
- Facility remediation
- Quality-related regulatory action
A licensing deal would be commercially relevant only if it transferred manufacturing capacity, regulatory rights, or geographic distribution rights. Patent licensing is unlikely to be the principal value driver.
How does iothalamate meglumine compare with modern contrast agents?
| Factor |
Iothalamate meglumine |
Nonionic low-osmolar agents |
| Osmolality |
Generally high |
Lower |
| Tolerability |
Less favorable in many settings |
Generally preferred |
| Acquisition cost |
Often lower |
Often higher |
| Patent exposure |
Minimal |
Varies by product, but many are mature |
| Hospital use |
Selected or legacy applications |
Broad |
| Growth potential |
Limited |
Driven by imaging volumes and formulary position |
| Supply-chain role |
Backup or niche supplier in some settings |
Core hospital inventory |
The product can retain value where hospitals prioritize low acquisition cost, where specific procedures remain familiar to clinicians, or where competing products are unavailable. Its long-term position is weaker in institutions that have standardized on nonionic agents.
What is the geographic coverage of iothalamate meglumine?
Iothalamate meglumine has historically been marketed across multiple jurisdictions, but current availability is country-specific. Regulatory approvals, product names, concentrations, and commercial suppliers differ by market.
The United States remains the most visible reference market because of FDA-approved Conray labeling. International demand depends on local imaging protocols, public procurement, generic competition, import requirements, and the availability of newer nonionic products.
Geographic risk is concentrated in markets where:
- One supplier controls local availability
- Hospitals rely on public tenders
- Imports require additional regulatory approval
- Contrast-agent production is concentrated outside the purchasing country
- Currency movements affect landed cost
What generic launch scenarios exist for iothalamate meglumine?
Three commercial scenarios are plausible.
Stable niche supply
An established supplier maintains the product as a profitable legacy line. Volumes decline gradually, but shortage events and institutional demand support continued sales.
Accelerated substitution
Hospitals move more rapidly to iohexol, iopamidol, ioversol, or iodixanol. Iothalamate meglumine becomes a small formulary product with declining purchasing relevance.
Shortage-supported demand
Disruptions affecting major nonionic products temporarily increase purchases of iothalamate meglumine. Revenue and utilization rise for a limited period, followed by normalization.
The second scenario is the most likely long-term direction in developed markets. The first remains viable where production costs are low and the product retains a dependable institutional customer base.
Key Takeaways
- Iothalamate meglumine is a mature iodinated contrast agent with little meaningful patent protection.
- Conray is the principal U.S. brand associated with the product.
- Core composition and conventional formulation patents are long expired.
- Paragraph IV litigation and biosimilar competition are not central risks.
- Revenue is not publicly reported as a standalone product figure.
- Financial performance depends on hospital contracts, manufacturing efficiency, supply reliability, and competition from nonionic agents.
- The long-term volume trend is likely stable to declining in developed markets.
- Shortages of competing contrast media can produce temporary demand increases.
- Manufacturing and regulatory compliance are more important barriers than intellectual property.
- No major current licensing transaction, patent settlement, or litigation appears to control the product’s commercial outlook.
FAQs
Is iothalamate meglumine still commercially available?
Yes, iothalamate meglumine remains associated with approved contrast-media products, including Conray in the United States, although availability varies by concentration, supplier, and market.
Is Conray a generic drug?
Conray is a branded product, but it contains a legacy active ingredient with no meaningful modern patent exclusivity. Its market is exposed to generic and therapeutic substitution.
Why do hospitals still use iothalamate meglumine?
Hospitals may use it because of established protocols, lower acquisition cost, available inventory, clinician familiarity, or temporary shortages of competing contrast agents.
Can a company launch a generic iothalamate meglumine injection?
A company can pursue approval through the applicable abbreviated or conventional FDA pathway, but it must establish sterile manufacturing, pharmaceutical equivalence, product quality, and reliable commercial supply.
Is iothalamate meglumine safer than iohexol?
Safety comparisons depend on the procedure, patient population, dose, renal status, allergy history, and institutional protocol. Iothalamate meglumine is an ionic, high-osmolar agent, while iohexol is a nonionic, low-osmolar agent. These products are not clinically interchangeable in every setting.
References
- DailyMed. (n.d.). Conray-30, Conray-43, Conray-60, and Conray-66: Iothalamate meglumine injection labeling. U.S. National Library of Medicine.
- U.S. Food and Drug Administration. (2025). Approved drug products with therapeutic equivalence evaluations: Orange Book.
- U.S. Food and Drug Administration. (2022). FDA statement on contrast media supply disruption and iodinated contrast availability.
