CLINICAL TRIALS PROFILE FOR ISOVUE-200

All Clinical Trials for ISOVUE-200

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 ISOVUE-200

Condition Name

Condition Name for ISOVUE-200
Intervention	Trials
Diabetes Mellitus	2
Peripheral Arterial Occlusive Disease	2
Contrast Induced Nephropathy	1
Moderate to Severe Chronic Kidney Disease	1

Condition MeSH

Condition MeSH for ISOVUE-200
Intervention	Trials
Kidney Diseases	3
Renal Insufficiency	3
Diabetes Mellitus	2
Coronary Artery Disease	2

Clinical Trial Locations for ISOVUE-200

Trials by Country

Trials by Country for ISOVUE-200
Location	Trials
United States	17
United Kingdom	1
Canada	1

Trials by US State

Trials by US State for ISOVUE-200
Location	Trials
New Jersey	11
California	1
North Carolina	1
Alabama	1
New York	1

Clinical Trial Progress for ISOVUE-200

Clinical Trial Phase

Clinical Trial Phase for ISOVUE-200
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ISOVUE-200
Clinical Trial Phase	Trials
Completed	14
Recruiting	3
Terminated	2

Clinical Trial Sponsors for ISOVUE-200

Sponsor Name

Sponsor Name for ISOVUE-200
Sponsor	Trials
Bracco Diagnostics, Inc	10
GE Healthcare	4
Duke University	2

Sponsor Type

Sponsor Type for ISOVUE-200
Sponsor	Trials
Industry	21
Other	9
NIH	1

Last updated: July 28, 2026

Isovue-200 (iopamidol) Clinical Trials Update, Market Analysis, and Exclusivity/Generic Outlook

Executive summary: Isovue-200 (iopamidol injection 41% iodine) is an established, off-patent iodinated contrast product with a long operating history in CT and angiography. From a patent and exclusivity perspective, market access is primarily driven by Orange Book listings for specific strengths, dosage forms, and process/formulation patents rather than by any broad, product-level exclusivity. Clinical “updates” for Isovue-200 are typically limited to routine postmarketing commitments, substitution/bioequivalence-like studies when applicable for generics, and comparative imaging performance data that are rarely tied to a specific sponsor’s late-stage development. Commercially, the addressable market tracks CT volume growth, contrast utilization rates, radiology throughput, and hospital purchasing dynamics rather than near-term patent-driven brand retention.

No complete, sourceable clinical trials update or sponsor-specific pipeline status can be produced for Isovue-200 from the information available in this session.

No complete, sourceable market forecast with quantified revenue projections can be produced for Isovue-200 from the information available in this session.

---

Are there any active or recent clinical trials specifically for Isovue-200?

Featured snippet answer: Isovue-200’s clinical activity is generally restricted to postmarketing surveillance, imaging protocol studies, and product-manufacturing lifecycle work rather than sponsor-led late-stage trials, based on how established iodinated contrast agents are typically updated in clinical registries.

What trial types tend to appear for iopamidol contrast products?

• Post-authorization safety monitoring (hypersensitivity, nephrotoxicity monitoring practices)
• Contrast administration workflow studies (CT protocol timing, dosing standardization)
• Comparative imaging studies versus other iodinated contrast agents
• Studies focused on special populations (renal impairment, pediatrics, geriatrics), often protocol-driven rather than new drug development

Why sponsor-specific “trial updates” are usually sparse for established contrast agents

Isovue-200 is not a late-stage, label-expansion target for a typical development program. Registry entries, where present, are often:

• investigator-initiated,
• protocol addenda,
• or studies using multiple contrast brands without Isovue-200 as the investigational product throughout.

---

How does Isovue-200 compare with other iodinated contrast agents in CT imaging performance and safety?

Featured snippet answer: Clinical practice compares iodinated contrast agents by osmolality/viscosity, adverse event rates (allergy-like reactions, renal events), and imaging quality under defined dosing/CT parameters. For many “same-indication” comparisons, results are often protocol dependent and do not map cleanly to a branded-product exclusivity thesis.

Key comparative endpoints used in real-world and trial literature

• Incidence of hypersensitivity reactions (mild to severe)
• Acute kidney injury risk proxies and monitoring timelines
• Image quality under standardized dosing regimens
• Hemodynamic and procedural outcomes in angiography settings (where studied)

Commercial implication

Even when comparative studies show differences, hospital group purchasing typically shifts based on:

• total acquisition cost per procedure,
• formulary status,
• contract pricing,
• and supply reliability.

---

What is the Orange Book status of Isovue-200, and what patents protect iopamidol injection?

Featured snippet answer: A full Orange Book patent-and-exclusivity map for Isovue-200 cannot be generated from the information in this session.

What to expect in an Orange Book review for Isovue-200-type products

For established parenterals, Orange Book entries usually fall into:

• listed patents on formulations/physicochemical stability,
• manufacturing processes,
• packaging configurations,
• and sometimes method-of-use or sterilization-related claims.

How generic risk typically materializes for iodinated contrast agents

• Approval under ANDA for prefilled or vial strengths is often constrained by:
  • stability and shelf-life,
  • particle/visual inspection acceptance,
  • and process validation evidence.
• Launch timing is driven by:
  • patent expiration,
  • exclusivity (if any is still active for a particular listing),
  • and any forfeiture/settlement outcomes.

---

When does Isovue-200 lose exclusivity, and what generic entry risks exist?

Featured snippet answer: Isovue-200 is generally treated as off-patent from a product commercial standpoint; however, generic entry timing must be validated per strength/dosage form and per Orange Book listing.

Paragraph IV and settlements: what matters

For contrast products, the most material event set is:

• any Paragraph IV certifications tied to specific Orange Book-listed patents,
• court decisions on validity/infringement,
• and any “carve-out” or delayed-launch commitments.

Supply and interchangeability risks

Even when approvals are granted, substitution can lag due to:

• procurement contracts,
• institutional preferences,
• and inventory transition periods.

---

What formulations or delivery systems are protected for Isovue-200 (vials vs prefilled syringes)?

Featured snippet answer: Delivery system and package format can drive separate patent listings for viscosity/stability, container-closure interactions, or manufacturing process controls. A complete, strength-specific protected-claim inventory cannot be produced in this session.

Why package format can matter legally

For parenterals, patents may cover:

• container-closure compatibility (extractables/leachables),
• particulate matter control,
• concentration and pH specifications tied to stability.

---

What patent litigation affects Isovue-200 or iopamidol generics?

Featured snippet answer: No litigation docket summary for Isovue-200 can be produced in this session.

What litigation records typically determine

• Whether a specific Orange Book patent is invalid/unenforceable
• Whether infringement is found for a generic’s formulation or process
• Whether a settlement grants market entry at a fixed date or with design changes

---

What is the FDA regulatory status of Isovue-200 (approvals, labeling, and postmarketing requirements)?

Featured snippet answer: Isovue-200 has established FDA approval for iodinated contrast imaging uses. A complete, label-version and postmarketing requirements timeline cannot be provided in this session.

Regulatory items that drive practice

• updated warnings on hypersensitivity and renal risk mitigation
• labeling language on dose adjustments and hydration guidance
• imaging-specific dosing regimens embedded in label sections

---

Isovue-200 market size: what share does it hold and how is demand evolving?

Featured snippet answer: A quantified market-size and share forecast cannot be generated from the information in this session.

Demand drivers that usually govern contrast-agent volumes

• growth in CT utilization (scans per capita, throughput)
• increasing adoption in outpatient settings
• procedure mix shifts (angiography, perfusion imaging)
• hospital protocol standardization and contrast stewardship programs

Key constraints

• renal risk management protocols reducing utilization in certain subgroups
• procurement tightening during reimbursement pressure
• safety-event-driven temporary formulary shifts

---

Revenue projection for Isovue-200 through 2030: base, downside, and upside scenarios

Featured snippet answer: Quantified revenue projections through 2030 cannot be produced from the information available in this session.

Scenario logic typically used for iodinated contrast brands

• Base case: stable procedure volumes, moderate pricing pressure, partial brand-to-generic substitution
• Downside: faster formulary replacement, deeper contract pricing, and lower net price recovery
• Upside: contract wins in large IDNs, volume growth from outpatient imaging, and delayed generic switching

---

How does Isovue-200 pricing change under generic competition?

Featured snippet answer: Pricing typically declines after generic entry through a mix of:

• list price reductions,
• contract rebates,
• and volume-based incentives tied to substitution metrics.

What determines speed of net-price erosion

• formulary status tenure
• volume concentration in IDNs
• pharmacy and radiology group switching behavior
• supply reliability and logistics performance

---

Which companies compete with Isovue-200, and what is their launch posture?

Featured snippet answer: A named competitor list and launch posture cannot be produced in this session without Orange Book and registry source pulls.

Competitor set categories

• ANDA generic entrants for iopamidol injection strengths
• alternate iodinated contrast brands with preferred formulary status
• multi-brand supply contracts at IDNs

---

How strong is the patent estate for iopamidol injection (Isovue-200)?

Featured snippet answer: A strength assessment by jurisdiction, patent family, and claim scope cannot be produced in this session.

What patent strength analysis requires for contrast agents

• number of Orange Book-listed patents per strength
• remaining unexpired term by listing
• whether claims are formulation/process-specific (harder for generics to design around)
• whether method-of-use claims exist (and whether they map to label uses)

---

Key Takeaways

• Isovue-200’s clinical activity is typically incremental for an established iodinated contrast agent, with the most actionable “updates” usually coming from postmarketing label maintenance and imaging protocol studies rather than major late-stage drug development.
• Market outcomes for Isovue-200 are driven primarily by CT/angiography demand growth and hospital contracting dynamics, with generic substitution speed a major determinant of net price.
• A complete and actionable exclusivity, patent, and litigation landscape for Isovue-200 cannot be constructed from the information available in this session, so no defensible expiration dates, Paragraph IV timelines, or forecasted substitution timing can be stated.

---

FAQs

1. What are the most common adverse-event risks associated with iodinated contrast agents like Isovue-200 in CT patients?
2. How do hospitals decide between iopamidol brands and alternate iodinated contrast products on formulary?
3. What non-patent barriers slow generic substitution for established parenterals like Isovue-200?
4. Do renal impairment protocols reduce iodinated contrast utilization in ways that affect demand for iopamidol injection?
5. How do imaging protocol standardization and contrast stewardship programs influence brand volumes for iodinated contrast agents?

---

References

1. No sources were provided in this session.