Last updated: August 1, 2026
Iopamidol-200 is a mature, nonionic, low-osmolar iodinated contrast medium containing 200 mg of iodine per mL. It is primarily used for radiographic contrast enhancement in selected angiographic and computed tomography procedures. Its clinical development is complete, and current activity is commercial rather than investigational. The principal product is Bracco Diagnostics’ Isovue-200, although iopamidol injection is also supplied through generic and institutional channels.
The product has limited patent or exclusivity protection, no biosimilar exposure, and low clinical-development risk. Commercial growth depends on imaging volumes, hospital purchasing, supply reliability, formulation equivalence, and price competition.
What is Iopamidol-200 and how is it used?
Iopamidol-200 is an injectable formulation of iopamidol at a concentration of 200 mg iodine/mL. Iopamidol is a triiodinated, nonionic contrast agent administered intravenously or intra-arterially, depending on the imaging procedure.
The 200 mg iodine/mL concentration is less concentrated than common 300 and 370 mg iodine/mL formulations. It is used where lower iodine concentration and specific injection-volume requirements are clinically appropriate.
| Attribute |
Iopamidol-200 |
| Active ingredient |
Iopamidol |
| Strength |
200 mg iodine/mL |
| Drug class |
Nonionic, low-osmolar iodinated contrast medium |
| Primary use |
Diagnostic radiographic contrast enhancement |
| Common brand |
Isovue-200 |
| Reference company |
Bracco Diagnostics Inc. |
| Route |
Intravenous or intra-arterial injection, depending on procedure |
| FDA status |
Approved drug product |
| Biologic |
No |
| Biosimilar pathway |
Not applicable |
| Development status |
Mature commercial product |
The FDA-approved labeling identifies iopamidol injection products for angiography and contrast-enhanced CT applications, with the precise indication depending on concentration and route of administration (Bracco Diagnostics, 2023).
What are the clinical trial and regulatory updates for Iopamidol-200?
Is Iopamidol-200 still in clinical development?
No. Iopamidol-200 is not a new molecular entity and is not undergoing a conventional Phase 1, Phase 2, or Phase 3 development program. The product was approved after historical clinical studies evaluating image quality, tolerability, hemodynamic effects, and adverse reactions associated with nonionic contrast administration.
Current clinical-trial records involving iopamidol generally relate to its use as:
- A comparator in studies of imaging protocols.
- A contrast agent in interventional cardiology or radiology studies.
- A control or procedural component in trials evaluating devices, imaging methods, or renal-protection strategies.
- A reference agent in studies of contrast-associated acute kidney injury.
These studies do not represent a new development program for the Iopamidol-200 formulation.
What is the FDA regulatory status of Iopamidol-200?
Iopamidol-200 is an approved prescription contrast agent marketed under an FDA-approved New Drug Application. Bracco’s Isovue product line includes multiple iodine concentrations, including 200 mg iodine/mL. The product is administered by trained health-care professionals and is subject to labeling requirements concerning hypersensitivity reactions, renal impairment, extravasation, thyroid dysfunction, and cardiovascular or neurologic complications.
The FDA label identifies several clinically relevant warnings:
- Serious hypersensitivity reactions can occur, including without a prior history of contrast allergy.
- Acute kidney injury is a recognized risk, particularly in patients with renal impairment, dehydration, diabetes, or other risk factors.
- Iodinated contrast can affect thyroid function in susceptible patients.
- Intra-arterial administration can produce thromboembolic, neurologic, cardiovascular, or local vascular complications.
The product’s regulatory risk is therefore concentrated in pharmacovigilance, manufacturing quality, supply continuity, and label compliance rather than clinical efficacy development.
What patents protect Iopamidol-200?
The core composition and use patents for iopamidol-200 are expired or commercially immaterial in the United States. Iopamidol was developed decades ago, and the product is in the post-exclusivity phase.
| Protection category |
Current assessment |
| Core composition patent |
Expired |
| Basic diagnostic-use patents |
Expired or commercially weak |
| Concentration-specific protection |
No meaningful remaining exclusivity identified |
| Formulation patents |
Any relevant historical protection is generally expired |
| Manufacturing patents |
Potentially relevant to process know-how, but not a broad market barrier |
| Pediatric exclusivity |
Not a current commercial barrier |
| Orphan-drug exclusivity |
Not applicable |
| Biosimilar exclusivity |
Not applicable |
Iopamidol is a small-molecule contrast agent rather than a biologic. Competitors do not need to establish biosimilarity. A manufacturer seeking market entry generally relies on an abbreviated or established-product regulatory route, subject to FDA requirements for pharmaceutical equivalence, bioequivalence or product-specific evidence, sterility, stability, and manufacturing controls.
What is the Orange Book status of Iopamidol-200?
The relevant FDA-listed product is the approved drug product and its associated NDA, rather than a biologic reference product. The practical commercial position is consistent with a mature, off-patent injectable medicine. No active patent barrier comparable to those covering recently launched specialty drugs is central to the market outlook.
Orange Book analysis must distinguish between the active ingredient, the branded product, the specific NDA, and individual presentations. A patent listed against one concentration or presentation would not automatically create broad protection over every iopamidol product. For Iopamidol-200, the principal competitive issue is product availability and purchasing economics, not patent exclusion.
When does Iopamidol-200 lose exclusivity?
Iopamidol-200 lost meaningful market exclusivity years ago. The product’s commercial life is governed by generic competition, hospital contracting, and manufacturing capacity.
The relevant timeline is:
| Period |
Commercial event |
| 1980s |
Iopamidol introduced and approved in major markets |
| Late 1980s to 1990s |
Expansion across angiography and CT applications |
| 2000s |
Broad transition into mature contrast-media market |
| 2010s |
Increasing procurement and generic competition |
| 2020-2024 |
Supply-chain, manufacturing, and hospital procurement factors became more important |
| 2025-2030 |
Expected mature-market competition with modest volume growth and continued price pressure |
There is no anticipated exclusivity cliff comparable to the loss of protection for a patented oral medicine. The market already operates under an off-patent model.
What formulations are protected by Iopamidol-200?
The principal formulation contains iopamidol in aqueous solution with excipients that support pH, stability, sterility, and compatibility with injection equipment. Formulation differentiation is limited because the product must meet strict specifications for:
- Iodine concentration.
- Osmolality.
- Viscosity.
- pH.
- Sterility and endotoxin limits.
- Particulate control.
- Container closure integrity.
- Stability over the labeled shelf life.
The 200 mg iodine/mL formulation competes with other iopamidol concentrations, including 300 and 370 mg iodine/mL products. Concentration selection is influenced by the imaging protocol, injection rate, catheter requirements, patient characteristics, and the desired iodine-delivery rate.
A formulation patent would have limited strategic value if it covered only routine excipient or packaging modifications that do not materially improve clinical or operational performance. Manufacturing consistency and regulatory documentation are more important barriers than exclusivity.
How strong is the patent estate for Iopamidol-200?
The patent estate is weak from a market-exclusion perspective and moderate from a manufacturing-protection perspective.
Core patent strength
The active pharmaceutical ingredient is old and widely known. Core composition claims do not provide meaningful protection against generic iopamidol products. A competitor can avoid infringement risk by relying on established chemical routes and independently developed manufacturing controls.
Formulation patent strength
Formulation claims may protect specific excipient combinations, container systems, or stability profiles. Their commercial value is limited unless they produce a clear regulatory or supply advantage. Most competing products can enter through alternative formulations that preserve pharmaceutical equivalence.
Manufacturing and quality barriers
Sterile injectable manufacturing remains a meaningful barrier. A new supplier must demonstrate:
- Validated aseptic or terminal-sterilization processes, as applicable.
- Control of iodine concentration and impurities.
- Container and closure compatibility.
- Stability under temperature and light conditions.
- Reliable supply of pharmaceutical-grade raw materials.
- FDA-compliant inspection and quality systems.
These barriers can delay entry even when patents are absent. They do not create long-term exclusivity by themselves.
Which companies compete with Iopamidol-200?
Iopamidol-200 competes in the broader iodinated contrast-media market rather than in a narrow single-product category.
| Company |
Competing contrast agents or market position |
| Bracco Diagnostics |
Isovue, including iopamidol products |
| GE HealthCare |
Omnipaque, based on iohexol |
| Bayer |
Ultravist, based on iopromide |
| Guerbet |
Xenetix and other iodinated contrast products in selected markets |
| Taiho and regional suppliers |
Iopamidol or other iodinated contrast products in selected jurisdictions |
| Generic injectable manufacturers |
Off-patent iopamidol and alternative contrast agents |
The strongest substitutes are not limited to other iopamidol products. Hospitals can switch among iohexol, iopromide, ioversol, iodixanol, and ioxilan when imaging protocols, formulary decisions, supply, and pricing permit.
How does Iopamidol-200 compare with competing contrast agents?
| Product |
Active ingredient |
Typical commercial position |
Key competitive factor |
| Isovue-200 |
Iopamidol |
Mature branded product |
Established use and supplier relationships |
| Omnipaque |
Iohexol |
Broadly used nonionic contrast agent |
Extensive hospital and imaging-center adoption |
| Ultravist |
Iopromide |
Broad diagnostic imaging use |
International commercial footprint |
| Optiray |
Ioversol |
Alternative low-osmolar agent |
Formulary and contract positioning |
| Visipaque |
Iodixanol |
Iso-osmolar contrast agent |
Selected renal-risk and procedural preferences |
Iopamidol-200 may be disadvantaged in procedures that require higher iodine delivery. In those settings, 300 or 370 mg iodine/mL products can deliver more iodine at the same volume or achieve a target iodine dose with less injected volume. Its position is stronger where the 200 mg iodine/mL concentration matches the protocol or where procurement favors a specific supplier.
What generic entry risks exist for Iopamidol-200?
Generic entry risk is high because the product is off-patent and clinically established. The principal risks are commercial rather than legal.
Generic and contract-manufacturing risks
Competitors can target hospitals, outpatient imaging centers, radiology groups, and group purchasing organizations. Entry is most likely to succeed where a supplier offers:
- Lower acquisition cost.
- Reliable inventory.
- Multiple vial and syringe sizes.
- Compatible packaging.
- Simplified purchasing across several iodine concentrations.
- Acceptable product-specific regulatory documentation.
Substitution risk from other molecules
Iopamidol-200 also faces substitution from other nonionic contrast agents. A hospital may switch the active ingredient without changing the underlying imaging service. This makes formulary placement and supply reliability important.
Supply interruption risk
Sterile injectable shortages can temporarily increase demand for alternative suppliers. The effect can be material because contrast media are procedural necessities. A supplier with redundant manufacturing sites and broad distribution can gain share during shortages even without product differentiation.
What is the market outlook for Iopamidol-200 from 2025 to 2030?
The outlook is stable to modestly growing in volume and pressured in price.
Volume projection
Demand should track:
- CT procedure growth.
- Angiography and interventional radiology volumes.
- Cardiovascular disease prevalence.
- Expansion of imaging infrastructure.
- Hospital and outpatient diagnostic capacity.
- Regional adoption of contrast-enhanced imaging.
A reasonable base-case outlook is low-single-digit annual volume growth in established markets, with higher growth possible in developing imaging markets. The growth rate will vary by geography and by procedure type.
Revenue projection
Revenue growth is likely to lag volume growth because of:
- Generic competition.
- Group purchasing organization negotiations.
- Multi-product hospital contracts.
- Substitution among iodinated contrast agents.
- Periodic price reductions following supply normalization.
The branded product may retain revenue through contract relationships and reliability, but the product should not be treated as a high-growth pharmaceutical asset. Public company filings generally report contrast-media revenue at portfolio or segment level rather than disclosing standalone Iopamidol-200 sales. A precise product-level forecast therefore cannot be derived from public financial reporting.
Scenario outlook
| Scenario |
2025-2030 expectation |
Main drivers |
| Base case |
Low-single-digit volume growth; flat to modest revenue growth |
Stable imaging demand and continuing price pressure |
| Upside case |
Mid-single-digit volume growth in selected regions |
Imaging expansion, supply shortages, stronger interventional volumes |
| Downside case |
Flat or declining revenue |
Generic substitution, contract losses, manufacturing disruption, reduced procedure volumes |
What licensing deals affect Iopamidol-200?
No major recent licensing transaction is central to the commercial outlook for Iopamidol-200. The product is primarily sold through established manufacturer, distributor, and hospital-procurement relationships.
Potential transaction value is more likely to arise from:
- Regional distribution rights.
- Contract manufacturing.
- Supply agreements.
- Portfolio acquisitions involving several contrast agents.
- Hospital or group purchasing contracts.
A standalone license for the underlying iopamidol molecule would have limited strategic value because the molecule is off-patent. The more valuable assets are manufacturing capacity, regulatory approvals, supply reliability, and access to institutional purchasing channels.
What patent litigation and Paragraph IV challenges affect Iopamidol-200?
No major active Paragraph IV litigation is central to the current Iopamidol-200 market outlook. Paragraph IV litigation is most commercially important when an applicant challenges unexpired Orange Book patents protecting a recently approved drug. Iopamidol-200 is a mature product with no comparable active exclusivity barrier.
Potential disputes would more likely concern:
- FDA approval of a specific generic presentation.
- Manufacturing process ownership.
- Trade secrets.
- Product quality.
- Supply contracts.
- Trademark or trade-dress rights.
- Patent claims directed to a narrow device, container, or formulation.
These issues would generally have a narrower market effect than a successful challenge to a core composition patent.
What is the commercial risk profile of Iopamidol-200?
| Risk category |
Assessment |
Business impact |
| Patent expiry |
High exposure already realized |
Limits price and market exclusivity |
| Clinical efficacy |
Low risk |
Long history of use and established labeling |
| Regulatory |
Moderate |
Injectable quality and pharmacovigilance remain critical |
| Manufacturing |
Moderate to high |
Sterile supply disruption can affect sales |
| Generic competition |
High |
Creates price and formulary pressure |
| Biosimilar competition |
None |
Small molecule, not a biologic |
| Substitution |
Moderate to high |
Competing iodinated agents can replace it |
| Demand |
Stable |
Linked to imaging and interventional procedure volumes |
| Litigation |
Low current exposure |
No major exclusivity dispute drives the market |
Key Takeaways
- Iopamidol-200 is an established 200 mg iodine/mL nonionic iodinated contrast agent.
- Its clinical development is complete; current trials involving iopamidol are generally procedural or comparative rather than registration studies.
- The product has no meaningful remaining core patent exclusivity.
- Biosimilar risk does not apply because iopamidol is a small molecule.
- Generic entry and substitution by iohexol, iopromide, ioversol, iodixanol, and other contrast agents are the main competitive threats.
- Sterile injectable manufacturing, quality compliance, inventory reliability, and hospital contracts are more important than patent barriers.
- The 2025-2030 outlook is stable to modestly growing in volume, with revenue constrained by pricing pressure.
- Product-level revenue projections are limited because manufacturers generally report contrast-media sales at portfolio or segment level.
- The most valuable commercial assets are regulatory approvals, manufacturing capacity, distribution, and institutional procurement access.
FAQs
Is Iopamidol-200 the same as Isovue-200?
Isovue-200 is Bracco’s branded iopamidol injection containing 200 mg iodine/mL. Other manufacturers may market equivalent iopamidol formulations under different product names.
Does Iopamidol-200 have biosimilars?
No. Biosimilars apply to biologic products. Iopamidol-200 is a small-molecule injectable drug and is subject to generic-drug regulatory principles instead.
Can hospitals substitute iohexol for Iopamidol-200?
Often, yes, subject to the imaging protocol, physician preference, formulary policy, patient factors, and product availability. The concentration and iodine-delivery rate must match the procedure.
Is Iopamidol-200 protected by a formulation patent?
Any historical formulation or process protection is unlikely to create a broad current market barrier. Manufacturing quality, sterility, and regulatory compliance are more significant entry requirements.
What is the principal investment risk for Iopamidol-200?
The principal risk is erosion of price and market share through generic competition, alternative contrast agents, hospital contracting, and supply-chain disruption.
References
-
Bracco Diagnostics Inc. (2023). Isovue-200, Isovue-250, Isovue-300, Isovue-320, and Isovue-370: Prescribing information. U.S. Food and Drug Administration.
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U.S. Food and Drug Administration. (2024). Drugs@FDA: FDA-approved drugs database. https://www.accessdata.fda.gov/scripts/cder/daf/
-
U.S. Food and Drug Administration. (2024). Approved drug products with therapeutic equivalence evaluations. U.S. Department of Health and Human Services.
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ClinicalTrials.gov. (2024). Search results for studies involving iopamidol. U.S. National Library of Medicine. https://clinicaltrials.gov/
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U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
