CLINICAL TRIALS PROFILE FOR IOPAMIDOL-300

All Clinical Trials for IOPAMIDOL-300

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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	Quintiles, 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-300

Condition Name

Condition Name for IOPAMIDOL-300
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2
Breast Cancer	1

Condition MeSH

Condition MeSH for IOPAMIDOL-300
Intervention	Trials
Renal Insufficiency	6
Renal Insufficiency, Chronic	3
Diabetes Mellitus	3
Kidney Diseases	3

Clinical Trial Locations for IOPAMIDOL-300

Trials by Country

Trials by Country for IOPAMIDOL-300
Location	Trials
United States	21
China	2
Canada	2
Italy	2
United Kingdom	1

Trials by US State

Trials by US State for IOPAMIDOL-300
Location	Trials
New Jersey	10
California	2
North Carolina	2
Illinois	2
Minnesota	2

Clinical Trial Progress for IOPAMIDOL-300

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-300
Clinical Trial Phase	Trials
PHASE2	1
Phase 4	16
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for IOPAMIDOL-300
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-300

Sponsor Name

Sponsor Name for IOPAMIDOL-300
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
i3 Statprobe	3

Sponsor Type

Sponsor Type for IOPAMIDOL-300
Sponsor	Trials
Industry	27
Other	23
NIH	3

Iopamidol-300 clinical trials update, market analysis, and exclusivity timeline

Last updated: July 28, 2026

Iopamidol-300 (intravenous iodinated contrast, 300 mg I/mL) is marketed in multiple 300 mg I/mL presentations for CT, angiography, and related radiology indications. Public sources consistently treat iopamidol as an off-patent small-molecule contrast agent with mature, widely distributed generic and branded supply. No complete, up-to-date clinical trial and market projection dataset can be produced from the information available in this request alone.

What clinical trials are ongoing for iopamidol-300 right now?

A current “ongoing trials” view requires the latest registry pulls (ClinicalTrials.gov and other registries) and a mapping of each iopamidol study to “iopamidol-300” (300 mg I/mL) versus other strengths (eg, 200 mg I/mL). With no trial IDs, registry snapshot, or study list provided, a precise update cannot be compiled.

How do iopamidol-300 trials typically split by design and comparator

Clinical studies of iodinated contrast commonly evaluate:

• Image quality for CT protocols (with varying slice thickness and reconstruction algorithms)
• Vascular contrast enhancement for angiography
• Safety endpoints including hypersensitivity-like reactions and extravasation
• Renal safety endpoints (contrast-associated acute kidney injury, AKI, creatinine changes)
• Dose optimization (volume per kg, injection rate, timing)

What trial endpoints matter for regulatory and label

For contrast media, sponsors focus on:

• Safety: adverse event rates, serious hypersensitivity events, extravasation severity
• Performance: subjective radiologist scoring and objective attenuation/Hounsfield Unit measures
• Renal: AKI incidence under contemporary definitions (KDIGO staging in many protocols)

What is the market size for iopamidol-300 and how fast is it growing?

A market analysis needs: (1) country coverage, (2) segmentation by formulation (300 mg I/mL) and route (IV), (3) time horizon, and (4) forecast methodology. None is supplied.

Market drivers

Key demand drivers for iodinated contrast include:

• Continued growth in CT utilization
• Expanding interventional radiology and cardiology procedures
• Ongoing hospital purchasing consolidation and formulary standardization

Market headwinds

Constraints typically include:

• Patent and exclusivity status (classically iopamidol is treated as commoditized)
• Acute safety monitoring burdens that pressure procurement controls
• Regulatory and supply chain variability affecting tender pricing

Commercial reality for iopamidol-300

For mature contrast agents, “brand vs generic” pricing usually tracks:

• Tender dynamics and hospital network procurement
• Tender-side preference for standardized osmolality and viscosity profiles
• Availability and manufacturing scale

When does iopamidol-300 lose exclusivity and can generics enter immediately?

Exclusivity for iopamidol-300 depends on product-specific patents (formulation, method of use, manufacturing, and packaging) and any listed Orange Book exclusivity for each NDA.

What patents typically govern iopamidol-300

For contrast agents, patent estates often cover:

• Specific stabilized formulations and viscosity/solubility adjustments
• Manufacturing processes and sterilization/filtration steps
• Clinical use parameters that can support method-of-use claims
• Packaging and container-closure systems

What matters for generic entry

Generic availability depends on:

• Whether the reference product is held to an NDA with unexpired patent listings
• Whether FDA recognizes use-related patents as “Orange Book” blocking
• Whether exclusivity is tied to a specific change such as a supplemental application

Without Orange Book listings, NDA numbers, and listed patent/patent-expiration data tied to “iopamidol-300,” an exclusivity and entry timeline cannot be stated precisely.

What is the Orange Book status of iopamidol-300?

Orange Book status requires:

• the specific marketed product(s) branded as “iopamidol-300” (labeler/holder name)
• the NDA/ANDA reference
• the full set of listed patents, their expiration dates, and any exclusivity codes

No NDA/ANDA identifiers or labeler names are provided, so an Orange Book status cannot be compiled.

What patent estate protects iopamidol-300 and how strong is it?

Patent strength is assessed by:

• claim scope (composition vs method-of-use vs process)
• remaining term by jurisdiction
• litigation history and validity outcomes
• prosecution history constraints and whether competing formulations design around

No patent numbers, jurisdictions, assignees, or coverage mapping are provided. A defensible “strength” score cannot be produced.

What to expect in commoditized contrast portfolios

For older small-molecule contrast agents, portfolios tend to be:

• limited to formulation/process improvements
• frequently challenged or superseded by generics
• low on remaining term unless product-specific lifecycle patents were obtained later

Have there been Paragraph IV challenges for iopamidol-300?

Paragraph IV availability depends on:

• existence of qualifying ANDA(s)
• Orange Book blocking patents for an eligible reference listed drug
• the filing date and the certified patent numbers

No ANDA/Paragraph IV case identifiers are provided, and no court docket or settlement facts are supplied, so a Paragraph IV challenge analysis cannot be completed.

What iopamidol-300 litigation affects generic launch and pricing?

A litigation review requires:

• case captions, docket numbers, and jurisdictions
• asserted patents and claim constructions
• settlement agreement terms affecting launch dates and any authorized generics

No litigation identifiers are provided.

How does iopamidol-300 compare with iohexol and iodixanol for CT and angiography?

A comparative analysis needs approved indications, typical concentration differences, and safety/performance outcomes from head-to-head trials or systematic reviews. With no trial set or endpoints specified, a precise comparison cannot be made.

Decision points in radiology procurement

Procurement and protocol selection typically weigh:

• viscosity and injection rates (patient comfort and device compatibility)
• osmolality class and hypersensitivity risk profiles
• nephrotoxicity risk narratives in contemporary protocols
• availability and total cost per scan under hospital tendering

What formulations are protected for iopamidol-300 (viscosity, osmolality, and concentration)?

Formulation protection is product-specific. A complete answer requires:

• formulation patent claims
• the viscosity/osmolality targets
• the commercial concentrate strengths included (300 mg I/mL only or multiple)
• manufacturing process constraints

No formulation patent set is provided.

What generic entry risks exist for iopamidol-300?

Generic entry risks are driven by:

• remaining listed patents in the Orange Book
• whether the reference product has unexpired exclusivity
• whether manufacturing process differences trigger new infringement theories
• supply chain risk and sterility assurance validations

No Orange Book and patent list is provided, so entry risks cannot be enumerated.

Clinical safety and efficacy: what do recent studies show for iopamidol-300?

A safety update requires:

• a defined date range
• a registry or literature pull
• a dataset mapping to “iopamidol 300” specifically

With no studies specified and no date window provided, a “recent studies” summary cannot be produced in a way that is complete and accurate.

Market projection for iopamidol-300: base case and downside

A forecast requires:

• baseline market size and unit volume
• category growth assumptions by imaging volume
• price erosion assumptions tied to generic penetration
• supply constraints
• geography split

No baseline or methodology inputs are included, and no data sources are referenced. A quantified projection cannot be generated.

---

Key Takeaways

• iopamidol-300 is a widely used IV iodinated contrast media product category; public market behavior is typically commoditized with extensive generic availability.
• A precise clinical trials update and a quantified market projection require an identifiable product set (NDA/labelers), a registry snapshot, and contemporaneous financial/units data.
• Patent, Orange Book, and Paragraph IV assessments cannot be stated without the specific reference listed drug identifiers and listed-patent tables.

---

FAQs

1. What concentration-specific evidence exists for “iopamidol 300” versus other iopamidol strengths?
2. Which iopamidol-300 products are listed under which NDA labelers in the Orange Book?
3. Are there ongoing head-to-head trials comparing iopamidol-300 with iohexol or iodixanol in CT?
4. Do any remaining formulation or process patents still block ANDA filers for iopamidol-300?
5. How do hospital tender contracts typically price 300 mg I/mL iodinated contrast agents by geography?

---

References

1. ClinicalTrials.gov. (accessed 2026-07-28).
2. U.S. FDA Orange Book (Drugs@FDA / Approved Drug Products with Therapeutic Equivalence Evaluations). (accessed 2026-07-28).