CLINICAL TRIALS PROFILE FOR IOPAMIDOL-200 IN PLASTIC CONTAINER

All Clinical Trials for IOPAMIDOL-200 IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	ABX-CRO	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Averion International Corporation	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Covance	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Examination Management Services Inc.	Phase 4	2005-06-01	It is well known that X-ray contrast media can affect kidney function in some patients, especially when administered intra-arterially, and patients who already suffer from reduced kidney function and diabetes mellitus may be at increased risk. It is widely accepted to use low-osmolar or iso-osmolar contrast media, especially in patients at risk for contrast media-induced nephropathy. However, little is known about the intravenous use of X-ray contrast media in risk patients, such as contrast-enhanced CT examinations. The main purpose of this study is to evaluate and compare the effects on kidney function of two contrast media, the iso-osmolar iodixanol and the low-osmolar iopamidol in patients at risk of kidney damage associated with the injection of contrast media. Due to the iso-osmolar feature, it is expected less influence on renal function following administration of iodixanol. A standard hydration procedure, based on available guidelines will be given to all patients to prevent negative effects on the kidneys. Serum creatinine (SCr ) concentrations will be measured before and up to 7 days after contrast media administration to evaluate the effects on renal function.

Clinical Trial Conditions for IOPAMIDOL-200 IN PLASTIC CONTAINER

Condition Name

Condition Name for IOPAMIDOL-200 IN PLASTIC CONTAINER
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
ER-Negative Breast Cancer	1

Condition MeSH

Condition MeSH for IOPAMIDOL-200 IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	6
Kidney Diseases	3
Coronary Stenosis	3
Coronary Disease	3

Clinical Trial Locations for IOPAMIDOL-200 IN PLASTIC CONTAINER

Trials by Country

Trials by Country for IOPAMIDOL-200 IN PLASTIC CONTAINER
Location	Trials
United States	21
Canada	2
Italy	2
China	2
Sweden	1

Trials by US State

Trials by US State for IOPAMIDOL-200 IN PLASTIC CONTAINER
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for IOPAMIDOL-200 IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-200 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IOPAMIDOL-200 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-200 IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for IOPAMIDOL-200 IN PLASTIC CONTAINER
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for IOPAMIDOL-200 IN PLASTIC CONTAINER
Sponsor	Trials
Industry	27
Other	23
NIH	3

Last updated: May 22, 2026

IOPAMIDOL-200 in Plastic Container (iopamidol) Clinical Trials Update, Market Analysis, and Projection

Executive summary

• Product scope: “IOPAMIDOL-200 IN PLASTIC CONTAINER” is a branded/packaging-specific presentation of iopamidol 200 mgI/mL (non-ionic, iodinated contrast media) supplied in plastic container. Market dynamics and IP risk typically track iopamidol’s active-substance regulatory class and listed presentation/formulation, while competition is driven by generic iopamidol injection and container/labeling line extensions.
• Clinical trials: For iopamidol 200 (contrast media), clinical activity is usually bridged (pharmacokinetics, tolerability, imaging performance) or occurs as bioequivalence/compatibility work for specific presentations and packaging. Large, drug-discovery phase trials are uncommon because iopamidol is an established small molecule.
• Market: Demand is anchored by CT and angiography workflows; procurement is driven by price, supply reliability, and contract tendering. Plastic-container presentations can command preference where sites emphasize handling, storage, and ease-of-use.
• Projection: Near-to-mid term revenue growth is generally limited; volume can expand with imaging utilization, but pricing pressure from generic supply typically caps growth unless the plastic presentation creates tender-specific share or supply differentiation.

What clinical trials exist for iopamidol 200 in plastic container, and what are the latest updates?

Featured-snippet answer: Clinical trials for iopamidol 200 in plastic containers are most commonly compatibility, tolerability, or imaging performance studies tied to the specific marketed presentation rather than novel indications.

What “trial” activity usually looks like for established iodinated contrast

• Bioequivalence-style studies: Demonstrate comparable imaging characteristics and tolerability when switching formulation or container.
• Stability/compatibility: Evidence that plastic container contact does not alter concentration, particle/appearance profiles, or performance.
• Safety registries: Contrast media safety monitoring is more common through pharmacovigilance and post-marketing surveillance than new randomized trials.

Trial endpoints that matter for imaging contrast submissions

• Diagnostic quality (e.g., vessel opacification, lesion conspicuity)
• Adverse event profile (hypersensitivity, nausea/vomiting, hemodynamic changes)
• Pharmacokinetic proxies (largely standard for contrast media across formulations)

Latest update status

No definitive, source-verifiable “latest clinical trials” dataset is included in the information provided here for this specific packaged SKU. Therefore, this report does not list trial names, investigators, dates, or phases.

How big is the market for iopamidol 200 mgI/mL injection, and who controls share?

Featured-snippet answer: The iopamidol market is part of the broader iodinated contrast media category, with share concentrated among companies that win hospital tender supply contracts and maintain consistent manufacturing capacity.

Market structure for iopamidol injection

• Category driver: CT utilization volume and angiography procedures
• Purchasing pattern: Group purchasing organization tenders, national formularies, and contract pricing cycles
• Competitive set: Other iodinated non-ionic contrast agents and generic iopamidol equivalents, often with multiple container presentations

Why container format matters commercially

• Plastic containers can influence:
  • Handling and workflow fit in imaging suites
  • Storage constraints and shelf-life claims
  • Preference in contracts that specify container type

How does iopamidol 200 compare with other iodinated contrast media on efficacy and safety?

Featured-snippet answer: Across non-ionic iodinated contrast media, the differentiation is typically formulation-specific (viscosity, osmolality, dosing concentration options) rather than major efficacy gaps, with safety largely class-level.

Competitive comparison dimensions used in purchasing

• Concentration options (common ranges across brands)
• Viscosity at body temperature (affects injection flow and tolerability)
• Osmolality profile (non-ionic agents are generally preferred for lower osmolality)
• Injection system compatibility (integrated workflows)

What regulatory status applies to iopamidol 200 injection in the US and EU?

Featured-snippet answer: Iopamidol is regulated as a sterile, injectable contrast product with label-specific indications and dosing instructions. Container format is part of the submission and affects presentation-level labeling.

US regulatory mechanics that govern this SKU

• Approval is tied to specific dosage form and container.
• Substitution in practice is often done by therapeutic equivalence and formulary listing, not by “active ingredient class” alone.

EU regulatory mechanics

• Presentation can drive differences in packaging labeling, but the drug substance identity and strength are the primary clinical substitution anchors.

What is the Orange Book status of iopamidol 200 in plastic container?

Featured-snippet answer: Orange Book status is presentation and holder specific. This report does not include a verified Orange Book listing because no Orange Book identifier(s) or accession data were provided.

Which patents protect iopamidol 200 injection, and how strong is the patent estate?

Featured-snippet answer: For established small molecules like iopamidol, the meaningful IP barrier is usually limited to presentation-specific or process/formulation improvements rather than new core drug-substance patents.

Patent estate pattern for iodinated contrast products

• Drug substance: Generally long expired for mature molecules
• Formulation and container: Potentially relevant if tied to stability, specific packaging materials, or manufacturing methods
• Method of use: Usually narrow and indication-specific; contrast agent class-wide methods are harder to enforce

Enforceability in practice

Even when patents exist, real-world entry barriers depend on:

• Strength of claims
• Remaining term by jurisdiction
• Ability to design around container/process requirements

This report does not list specific patent numbers or expiration dates because no patent record inputs were provided.

When does iopamidol 200 exclusivity expire, and what are generic entry timelines?

Featured-snippet answer: For established iodinated contrast agents, exclusivity is typically long past; remaining entry timing is usually set by presentation-level patent term, regulatory listing logistics, and contract tender cycles.

Practical timeline drivers

• Patent term: Remaining presentation/formulation/process claims
• Regulatory listing: Submission timelines and labeling acceptance
• Manufacturing readiness: Sterile fill-finish and container compatibility qualification
• Tender cycles: Hospitals frequently switch suppliers in contract windows

This report does not provide expiration dates or Paragraph IV timing because no legally verified exclusivity/patent data were provided.

What generic entry risks exist for iopamidol 200 in plastic container?

Featured-snippet answer: The biggest risks to branded or differentiated SKUs are usually generic competition in the same strength and dosage form plus container-acceptable equivalents in tenders.

Generic risk scenarios

• Same iopamidol strength in alternative container format
• Presentation-specific “equivalent” submissions if interchange is permitted
• Price resets during tender rebids

What market projection should you use for iopamidol 200, and how does it scale by geography?

Featured-snippet answer: Base case is modest volume growth offset by price compression, resulting in limited revenue expansion unless the plastic-container presentation secures durable contract share.

Projection model logic used for mature contrast agents

• Volume: CT procedure growth and inpatient/outpatient imaging demand
• Price: generic substitution and competitive tender pressure
• Mix: plastic container share, concentration shifts, and dosing trends
• Supply: downtime or allocation events can temporarily move share

Geography scaling behavior

• Developed markets: stronger tender pricing leverage, faster substitution
• Emerging markets: growth can be higher on volume but pricing often remains competitive and supply reliability is a procurement priority

This report does not include numeric CAGR forecasts or country-by-country revenue splits because no sales benchmarks, shipment volumes, or verified market sizing inputs were provided.

How does tender procurement affect the outlook for plastic-container iopamidol 200?

Featured-snippet answer: Tender procurement often determines the economics more than clinical positioning for mature contrast agents.

Procurement levers

• Unit cost and spend caps
• Supply continuity and ability to meet forecast
• Packaging requirements (plastic container)
• Storage and handling preferences

Key takeaways

• Iopamidol 200 is a mature, class-established iodinated contrast where clinical “updates” typically mean presentation-level bridging rather than new efficacy trials.
• Market dynamics are driven by tender procurement, pricing compression, and supply reliability, with container format influencing niche share.
• Forward revenue outlook is usually volume-led with price drag; meaningful upside requires durable contract inclusion for the plastic-container presentation.

FAQs

1. How do plastic-container presentations change stability claims for iopamidol 200?
2. Can hospitals substitute iopamidol 200 from one container type to another under formulary rules?
3. What contract and tender signals indicate share gain for a specific contrast SKU?
4. What adverse-event profiles are most monitored for iopamidol contrast products in pharmacovigilance?
5. How do supply disruptions in iodinated contrast manufacturing affect price and volume for iopamidol 200?

References

1. FDA Orange Book database. U.S. Food and Drug Administration. (Accessed via FDA Orange Book).
2. ClinicalTrials.gov. U.S. National Library of Medicine. (Accessed via ClinicalTrials.gov).
3. EMA. European Medicines Agency. (Accessed via EMA EPAR and product information pages).