CLINICAL TRIALS PROFILE FOR IOPAMIDOL-250 IN PLASTIC CONTAINER

All Clinical Trials for IOPAMIDOL-250 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.
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.
NCT00209417 ↗	Renal Effects of Two Iodinated Contrast Media in Patients at Risk Undergoing Computed Tomography	Terminated	GE Healthcare	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-250 IN PLASTIC CONTAINER

Condition Name

Condition Name for IOPAMIDOL-250 IN PLASTIC CONTAINER
Intervention	Trials
Coronary Artery Stenosis	3
Coronary Artery Disease	2
Diabetes Mellitus	2
Contrast Media Adverse Reaction	1

Condition MeSH

Condition MeSH for IOPAMIDOL-250 IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	6
Kidney Diseases	3
Coronary Stenosis	3
Coronary Disease	3

Clinical Trial Locations for IOPAMIDOL-250 IN PLASTIC CONTAINER

Trials by Country

Trials by Country for IOPAMIDOL-250 IN PLASTIC CONTAINER
Location	Trials
United States	21
China	2
Canada	2
Italy	2
Sweden	1

Trials by US State

Trials by US State for IOPAMIDOL-250 IN PLASTIC CONTAINER
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for IOPAMIDOL-250 IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-250 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-250 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-250 IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for IOPAMIDOL-250 IN PLASTIC CONTAINER
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for IOPAMIDOL-250 IN PLASTIC CONTAINER
Sponsor	Trials
Industry	27
Other	23
NIH	3

Last updated: May 26, 2026

Iopamidol-250 (in Plastic Container) Clinical Trials Update, Market Analysis, and Launch Projections

Executive summary: No current, verifiable public information is provided here that identifies (1) a specific U.S. FDA application number and Orange Book listing for “iopamidol-250 in plastic container,” (2) an active clinical trial registry entry tied to that exact container configuration, or (3) a measurable commercial footprint and sponsor attribution at product-label level. Without those identifiers, a complete and accurate clinical-trials update, litigation/exclusivity mapping, and market projection for this exact product cannot be produced.

What clinical trials involve iopamidol-250 in plastic containers?

Featured snippet answer: None can be reported from the provided information.

Which trial registries would normally be checked

• ClinicalTrials.gov (interventional studies, safety and efficacy)
• EU Clinical Trials Register (EudraCT equivalents)
• WHO ICTRP aggregations

What “plastic container” changes in clinical evidence

• Potential relevance to:
  • container-related extractables/leachables
  • osmolality stability over shelf life
  • usability endpoints (ease of administration, volume accuracy)
  • immunogenicity is not typically a driver for small-molecule iodinated contrast, but local tolerability can be container/closure dependent

What is the market size for iopamidol-250 contrast in plastic containers?

Featured snippet answer: No product-level market size can be calculated from the provided information.

How to segment demand (what analysts use)

• By concentration: 250 mg I/mL vs other iopamidol strengths
• By presentation: prefilled plastic vs vial or glass
• By route: IV vs intra-arterial (if applicable)
• By geography: US vs EU vs rest of world
• By setting: hospitals vs imaging centers

Price and volume drivers that usually matter

• reimbursement and tendering behavior for contrast media
• supply constraints for iodinated contrast
• generic substitution rules and pharmacy purchasing agreements
• tender-driven switching across suppliers within the same concentration

When could iopamidol-250 in plastic container lose exclusivity?

Featured snippet answer: Exclusivity timing cannot be determined without the referenced FDA product listing and associated patent/ROUTE mapping.

What to check for exclusivity and patent term

• Orange Book:
  • listed drug (RLD) and applicant
  • patent numbers and expiration dates
• FDA exclusivity:
  • 5-year new chemical entity (NCE), if ever applicable to iopamidol (often long-established)
  • 3-year new clinical investigation exclusivity
  • 505(b)(2) exclusivity, if relevant
• Patent families:
  • composition/therapeutic use
  • formulation and container/closure systems
  • manufacturing/process patents

What patents protect iopamidol-250 (plastic container presentation)?

Featured snippet answer: Patent coverage cannot be enumerated from the provided information.

Patent categories that commonly appear for iodinated contrast products

• container/closure system patents
• formulation stabilizers and buffering systems
• manufacturing steps affecting viscosity, stability, and sterility assurance
• method-of-use patents (less common for standard contrast delivery indications)

How many patents typically cover a presentation

• Small-molecule contrast products often have multiple Orange Book entries:
  • active ingredient-related patents (composition)
  • specific formulation changes
  • process patents
  • limited device/container claims if pursued

What generic entry risks exist for iopamidol-250 in a plastic container?

Featured snippet answer: No risk ranking can be produced without knowing:

• the referenced RLD
• Orange Book patent list
• any Paragraph IV history
• litigation dockets tied to the exact presentation

Paragraph IV and litigation pathways (what matters operationally)

• whether the applicant files an ANDA for the same dosage form and container
• whether the court record addresses:
  • generic product composition
  • container extractables and specs
  • stability data and release specifications
  • label equivalence

How does iopamidol-250 compare with other iodinated contrast agents on utilization and access?

Featured snippet answer: No comparative utilization outcomes can be assigned from the provided information.

Typical competitive set for iopamidol

• Nonionic, low-osmolar iodinated contrast agents at comparable iodine concentrations
• Substitutable within contrast media tenders and formularies

What shifts utilization

• price and tender selection
• adverse event profiles and institutional protocols
• renal risk management pathways
• imaging modality demand trends

What is the Orange Book status of iopamidol-250 in plastic containers?

Featured snippet answer: Orange Book status cannot be verified from the provided information.

What the Orange Book listing would show

• applicant and listed drug name
• patent numbers with listed expiration dates
• exclusivity codes and dates (if applicable)

What FDA status does iopamidol-250 in plastic containers have (approved vs pending)?

Featured snippet answer: FDA approval status cannot be confirmed from the provided information.

What to check in FDA databases

• Drugs@FDA record for product strength and container description
• labeling and NDC-level approval history
• shortages and discontinuations signals

How strong is the patent estate for iopamidol-250 plastic-container products?

Featured snippet answer: Patent estate strength cannot be assessed from the provided information.

How analysts score patent estates

• number of active composition/formulation patents remaining
• how many are enforceable and jurisdiction-specific
• whether any patents have been litigated or invalidated
• whether container/closure patents align to ANDA generic design constraints

What patent litigation affects iopamidol-250 in plastic containers?

Featured snippet answer: No litigation can be identified from the provided information.

What usually drives high-stakes litigation for injectables

• ANDA/505(b)(2) challenges for formulation or container claims
• disputes over bioequivalence and stability comparability
• interpretive disputes on patent claim scope

What settlement agreements or consent decrees impact future generic entry?

Featured snippet answer: None can be reported from the provided information.

Market projection: how much volume and revenue could iopamidol-250 plastic container capture?

Featured snippet answer: No credible projection can be produced without:

• confirmed marketed products and NDC mapping
• channel-level pricing/volume baselines
• competitive entries and tender schedules

Launch scenarios: base case, upside, downside for iopamidol-250 plastic container

Featured snippet answer: Launch scenarios cannot be modeled without validated product identity, competitor set, and regulatory/patent timelines.

What scenario modeling requires

• expected time to generic competition
• percent price erosion by tender cycle
• inventory and shortage effects
• uptake constraints driven by procurement contracts

---

Key Takeaways

• A complete clinical-trials update, patent/exclusivity map, Orange Book status, and market projection for “iopamidol-250 in plastic container” cannot be produced from the information provided.
• Product-level container configuration (plastic vs vial/glass) can materially change regulatory and IP analysis, but the necessary identifiers are absent here.

FAQs

1. Is iopamidol-250 considered low-osmolar nonionic contrast, and does the container change safety outcomes?
2. Do generic iopamidol-250 products need to match the same container/closure system to be considered equivalent?
3. How do contrast media shortages affect iopamidol purchasing and pricing by hospital formularies?
4. What tenders determine uptake of iopamidol-250 versus competing iodinated contrasts in the US?
5. How would a Paragraph IV challenge to container/closure patents typically appear in litigation records?

References

(No citations provided because no verifiable sources were supplied in the input.)