CLINICAL TRIALS PROFILE FOR IOPAMIDOL-370 IN PLASTIC CONTAINER

All Clinical Trials for IOPAMIDOL-370 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-370 IN PLASTIC CONTAINER

Condition Name

Condition Name for IOPAMIDOL-370 IN PLASTIC CONTAINER
Intervention	Trials
Coronary Artery Stenosis	3
Diabetes Mellitus	2
Coronary Artery Disease	2
Hypothyroidism	1

Condition MeSH

Condition MeSH for IOPAMIDOL-370 IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	6
Kidney Diseases	3
Coronary Stenosis	3
Coronary Disease	3

Clinical Trial Locations for IOPAMIDOL-370 IN PLASTIC CONTAINER

Trials by Country

Trials by Country for IOPAMIDOL-370 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-370 IN PLASTIC CONTAINER
Location	Trials
New Jersey	10
Minnesota	2
California	2
North Carolina	2
Illinois	2

Clinical Trial Progress for IOPAMIDOL-370 IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for IOPAMIDOL-370 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-370 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	15
Recruiting	6
Terminated	5

Clinical Trial Sponsors for IOPAMIDOL-370 IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for IOPAMIDOL-370 IN PLASTIC CONTAINER
Sponsor	Trials
Bracco Diagnostics, Inc	8
GE Healthcare	6
National Cancer Institute (NCI)	3

Sponsor Type

Sponsor Type for IOPAMIDOL-370 IN PLASTIC CONTAINER
Sponsor	Trials
Industry	27
Other	23
NIH	3

Last updated: August 1, 2026

Iopamidol-370 in Plastic Container Clinical Trials Update, Market Analysis & 2026–2032 Projection

Iopamidol-370 in plastic container is a contrast medium product presentation built around iopamidol 370 mgI/mL for intravascular and other radiographic uses. Public clinical-trial activity and brand-specific market disclosures for the exact “in plastic container” presentation are limited in open sources, so the most reliable investment framing is a presentation-level adoption view (switch from glass/alternate containers where applicable), IP and regulatory lock-in via product-specific labeling/CMC, and contract manufacturing and tender dynamics typical for iodinated contrast media.

Bottom line for commercial projection (2026–2032): growth is driven by imaging volume and tender-driven procurement cycles; downside is price competition from lower-cost generics and alternative iodinated contrast products, plus periodic supply/quality events that affect batch allocation. Presentation-level differentiation (plastic container, delivery usability) typically supports channel access rather than creating premium pricing power.

---

Are there active clinical trials for iopamidol-370 in plastic container?

Featured snippet answer: No reliably identifiable, presentation-specific interventional trial registry footprint is evident in major public databases at the level of “iopamidol-370 in plastic container” as a distinct investigational product label. Clinical research for iopamidol products is generally registered at the active ingredient or branded-product level without explicitly isolating the container configuration.

What kinds of trials are most common for iodinated contrast products

Clinical development in iodinated contrast media usually concentrates on:

• Comparative imaging performance and safety endpoints (contrast efficacy, angiographic quality).
• Safety and tolerability in target populations (renal impairment, allergy history stratification).
• Administration parameters (rate of injection, premedication regimens).
• Device and delivery method studies (syringe compatibility, flow characteristics, container usability), which sometimes do not register the container as a separate investigational product category.

How to treat “container” as a clinical variable

A plastic container is typically a CMC and administration usability change rather than a change in the active moiety. If a container transition occurs, regulators often treat it as a formulation/packaging change requiring comparability packages rather than new efficacy trials, unless there is a material interaction concern.

---

What is the current regulatory status of iopamidol-370 products in plastic containers?

Featured snippet answer: Regulatory status for iodinated contrast products is primarily driven by the approved iopamidol strength, labeling indications, and CMC comparability for the container. Presentation-level plastic container changes usually fall under supplemental applications rather than standalone new approvals, unless a pathway and jurisdiction-specific requirements treat the presentation as a separate marketing authorization.

US (FDA): Orange Book and labeling linkage

In the US, contrast media are typically tracked through:

• FDA product labeling and medication guides (when applicable).
• NDA/BLA listing for branded products and Abbreviated New Drug Applications (ANDAs) for generics.
• Orange Book entries for application-level exclusivity and listed patents that can include formulation, manufacturing, and method-of-use claims tied to specific dosage forms and strengths.

For “iopamidol-370 in plastic container,” the key business question is whether the plastic container drives a distinct application listing (separate NDA/ANDA product) or is covered by the same application with a packaging change. The market risk and exclusivity posture differ materially between these scenarios.

EU: marketing authorization for medicinal product vs variations

In the EU, container changes are often handled as:

• Variation procedures under the marketing authorization.
• CMC comparability with physicochemical and safety testing.
• Labeling alignment for administration and compatibility language.

Canada, UK, other jurisdictions

Other markets typically mirror the EU pattern: the active ingredient approval is stable, while container configuration changes are managed as variations unless a new authorization is required for local distribution.

---

What patents protect iopamidol-370 presentations, and do they differ by container?

Featured snippet answer: The patent estate for iopamidol as an active ingredient is usually mature or expired. The remaining enforceable IP tends to be product-specific: manufacturing process, packaging/container technology, and/or specific labeling claims. Container differences can be protected via secondary claims, but many “container-only” changes are addressed via CMC comparability rather than novel claims with strong commercial exclusion.

Likely IP buckets for iodinated contrast media

1. Manufacturing process patents
   Purification, crystallization/formulation conditions, or impurity profiles for specific strengths.
2. Composition/formulation patents
   Stabilizers, pH targets, viscosity modifiers, or monomeric/complexation characteristics.
3. Packaging/container patents
   Container material compatibility, seal systems, leachables control, and manufacturing integration.
4. Use and method-of-use patents
   Less common for contrast media at this scale because imaging protocols typically face broad clinical practice adoption.

Why “plastic container” can matter for IP

If a specific container system reduces extractables/leachables or improves stability, the IP may reside in CMC data packages and manufacturing know-how. Litigation risk is lower for container-only features if they are not tied to a clear, enforceable claim that maps to generic packaging configurations.

---

When does iopamidol-370 lose exclusivity, and what drives entry timing?

Featured snippet answer: Entry timing is usually driven by:

• Patent expiration of any late-remaining process/formulation claims.
• Any listed FDA patent terms on the specific product listing used in procurement.
• Supplemental exclusivities or regulatory exclusivities tied to that specific NDA/ANDA product presentation.
• ANDA approval timing and any paragraph IV challenges (if present).

For iopamidol, exclusivity is often not the binding constraint. Procurement contracts and quality validation cycles are.

What actually governs generic launch readiness

• CMC comparability acceptance for container and labeling.
• Supplier qualification by large hospital systems.
• Tender cycles and formulary lock.
• Supply chain resilience and storage compatibility.

---

What competitive landscape exists for iopamidol 370 mgI/mL contrast media?

Featured snippet answer: The competitive arena is dominated by multiple generic and branded iodinated contrast media versions at the 370 mgI/mL strength, with competition primarily on price, supply reliability, contract terms, and packaging usability rather than differentiated clinical outcomes.

Key competitive vectors

• Unit pricing vs pack economics (single-use vials vs larger containers, depending on market).
• Tender scoring for supplier continuity and delivery performance.
• Renal safety narratives (particular attention to hydration protocols and labeling).
• Osmolality/viscosity positioning relative to alternative contrast strengths and agents (e.g., 300 mgI/mL products vs 370 mgI/mL products).
• Device compatibility (injector compatibility, syringe/connector standards, and flow consistency).

How to interpret “plastic container” in procurement

Plastic containers can reduce packaging breakage risk versus glass and improve handling. That tends to support distribution continuity and logistics acceptance, especially for high-volume imaging centers.

---

What market size and growth drivers apply to iopamidol-370 contrast media?

Featured snippet answer: Market growth is primarily an imaging volume function (CT and angiography demand) with an overlay from procurement rationalization and substitution among iodinated contrast agents.

Primary demand drivers

• Growth in CT utilization.
• Aging populations and associated imaging needs.
• Increased cardiology and vascular imaging.
• Adoption of standardized hydration and imaging protocols.

Primary headwinds

• Patent and generic substitution (where applicable) driving price compression.
• Safety-related label scrutiny and insurer/hospital protocol adjustments.
• Supply interruptions, batch failures, or container integrity issues.

Where projections typically break

Projections are highly sensitive to:

• Hospital contract renewals.
• Supplier-specific allocation during shortages.
• Currency and importation dynamics in less mature markets.

---

How should 2026–2032 revenue projections be modeled for iopamidol-370 in plastic containers?

Featured snippet answer: Model at the presentation level using imaging-driven baseline growth plus a procurement share variable for container form. Use a three-scenario case (base, downside, upside) around pricing and share stability.

Recommended projection structure (presentation-level)

1. Demand volume
   • Screened proxy: total iodinated contrast imaging share of iodinated contrast products at 370 mgI/mL.
   • Convert imaging volume to dose volume using average vial/container utilization assumptions (contract and regimen driven).
2. Price realization
   • Net price after tender discounts.
   • Erosion rate tied to generic competition and procurement negotiation.
3. Share of plastic-container presentation
   • Uptake or substitution from alternate packaging.
   • Capacity constraints that can either cap share gain or create temporary share spikes.

Scenario assumptions that fit contrast media economics

• Base case: modest volume growth, moderate price erosion, slow adoption of preferred packaging.
• Downside: sharper price compression plus share loss due to tender wins by alternative SKUs or container formats.
• Upside: supplier reliability improves, driving increased formulary share during shortage-prone periods.

---

What generic entry risks exist for iopamidol-370 in plastic containers?

Featured snippet answer: The highest generic entry risks are regulatory and CMC comparability acceptance plus supplier tender lock, not patent-driven exclusivity. If a competitor’s ANDA matches the active substance specification, labeling, and container integrity requirements, market entry can occur quickly after regulatory approval.

Entry blockers that matter in practice

• Container-related extractables/leachables and stability data acceptance.
• Injector compatibility validation in hospital workflows.
• Batch-to-batch consistency in impurity and pH ranges.
• Pharmacovigilance handling and post-market deviation management.

---

How strong is the patent estate for iopamidol 370 products?

Featured snippet answer: For iopamidol 370 mgI/mL, the enforceable IP strength is typically weaker than in novel therapeutics. If there are any remaining enforceable patents, they are often narrow (process/formulation or packaging-related) and may not broadly block generic substitution.

Litigation reality for mature APIs

Contrast media litigations, when they occur, are usually:

• Narrowly focused on listed patents tied to a specific product.
• Resolved via settlements that allow early entry while preserving a small remaining market segment.

---

What patent litigation affects iopamidol-370 contrast media?

Featured snippet answer: Presentation-level litigation for iopamidol 370 is not commonly prominent in public summaries at the granular level of “plastic container” SKUs. Where litigation exists, it is usually product-listing specific rather than container-only.

How to map litigation to market impact

Even a concluded or settled case can matter if:

• A generic is delayed.
• A settlement imposes launch timing or packaging constraints.
• A particular presentation (container) is excluded even if the active ingredient is approved.

---

Are there licensing deals or settlements for iopamidol 370 presentations?

Featured snippet answer: Licensing and settlement activity, when present, tends to be application- and patent-listing specific, and is often confidential. The practical market impact shows up via:

• Launch timing relative to formulary procurement cycles.
• Availability during shortages and allocation.

---

How does iopamidol-370 in plastic container compare with iopamidol 370 in glass or other packaging?

Featured snippet answer: Clinical performance is generally equivalent because the active ingredient and dose strength govern contrast properties. The decisive differences are handling, stability data management, and compatibility with injectors and hospital workflows.

Decision factors used by hospitals

• Breakage and storage safety.
• Ease of transfer from container to syringe system.
• Stability shelf-life and wastage rates.
• Compatibility with high-throughput CT injection workflows.

---

Key Takeaways

• Presentation-specific clinical trials for “iopamidol-370 in plastic container” are not clearly identifiable in public registries as a distinct investigational category; development is usually managed as CMC/package variation rather than new efficacy trials.
• Regulatory timing for plastic-container SKUs is typically governed by CMC comparability and product listing acceptance more than by broad exclusivity.
• Market growth through 2026–2032 is driven mainly by imaging volume and contract procurement economics, with price erosion as the principal risk.
• The strongest commercial levers are formulary share, tender outcomes, supply reliability, and container-handling acceptance, not IP-driven barriers.
• Projection modeling should treat container format as a share variable layered onto overall iodinated contrast 370 mgI/mL demand and net price erosion dynamics.

---

FAQs

1) Is iopamidol-370 in plastic container considered a different drug than other iopamidol 370 presentations?

Usually the active ingredient and strength define the drug; container changes are typically handled as presentation variations under the same marketing authorization framework, unless a jurisdiction treats the presentation as a distinct product listing.

2) Do container changes require new clinical trials for iopamidol-370?

Often they require comparability evidence (CMC, stability, extractables/leachables, and administration usability). New efficacy trials are generally not the default path for container-only modifications.

3) What drives tender selection for iodinated contrast media like iopamidol 370?

Net unit pricing, supply reliability, storage/handling practicality, injector compatibility, and contract terms with performance guarantees during demand spikes.

4) Can a generic iopamidol 370 enter quickly if patents are expired?

Regulatory approval can be the gating factor, but market entry is commonly constrained by hospital qualification and tender cycle timing even after approval.

5) Does plastic packaging reduce clinical safety concerns versus glass?

Safety concerns in iodinated contrast media are dominated by the drug’s pharmacology and patient factors. Packaging mainly impacts logistics, handling, and risk of physical defects, not contrast chemistry.

---

References

1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. US Food and Drug Administration.
2. EU Commission. Variations and regulatory procedures for medicinal products in the European Union. European Medicines Agency framework materials.
3. ClinicalTrials.gov. Search results for iopamidol clinical trials. National Library of Medicine.