CLINICAL TRIALS PROFILE FOR ULTRAVIST 300 IN PLASTIC CONTAINER

All Clinical Trials for ULTRAVIST 300 IN PLASTIC CONTAINER

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00244140 ↗	Ultravist: Safety and Efficacy in Computed Tomography of Head and Body	Completed	Bayer	Phase 3	2005-10-01	This is a research study involving the use of a contrast agent called Ultravist Injection. Ultravist, the study drug, is used to improve the pictures obtained using computed tomography (CT). Ultravist acts like a dye to make CT pictures brighter and easier to read. In the case of this study, it will be injected into a vein in the patient's arm; from there, it travels through the blood stream and to the areas to be examined. CT scans will then be taken of the patient's head and/or body as ordered by his/her physician. Phase IIIb Study to Document the Safety and Efficacy of Ultravist 370 mg I/ml, When Administered Intravenously, in Volumes up to 162.2 ml, for Clinically Indicated Contrast Enhanced Computed Tomography (CECT) of the Head and/or Body
NCT00876083 ↗	PMS Study Ultravist-IMAGE, IoproMide (UltrAvist) to Gain Further Information on Tolerability and Safety in X-ray Examination	Completed	Bayer		2008-03-01	The purpose of this study is to obtain data on the safety and efficacy of Ultravist application in usual daily use.The radiologist will administer the contrast medium to the patient as he/she would have done without the study. No other examinations will be performed than would have been done routinely.
NCT00926562 ↗	A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients	Completed	Chinese PLA General Hospital	Phase 4	2009-02-01	The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
NCT01206257 ↗	The Safety and toleRability of UltraviSt in Patients Undergoing Cardiac CaTheterization (TRUST)	Completed	Bayer		2010-08-01	This study is to collect the information of Ultravist® in the patients indicated for the coronary angiography or PCI, like rate of ADR in patients, the dose for different indications, image quality to prove Ultravist the good safety and effectivity
NCT01255722 ↗	Xenetix® 350: Comparative Assessment of Image Quality for Coronary CT Angiography	Completed	Guerbet	Phase 4	2010-11-01	The purpose of this study is to demonstrate the (statistical) non-inferiority of iobitridol (Xenetix® 350) when compared to contrast agents with higher iodine concentrations, iopromide (Ultravist® 370) and iomeprol (Iomeron® 400) in terms of coronary CT scan evaluability (quality and interpretability of images).
NCT01415414 ↗	Observational Study of Ultravist in Patients Requiring CECT	Completed	Bayer		2011-09-01	It is a prospective, non-interventional, multi-center study. The primary objective of this study is to evaluate the image quality of Ultravist in patients requiring contrast-enhanced CT considering the routine use in patient population's, region's indication.
NCT01448889 ↗	Normobaric Hyperoxygenation for Prevention of Contrast Induced Nephropathy	Unknown status	Assaf-Harofeh Medical Center	N/A	2009-09-01	Acute renal failure induced by radiographic contrast agents is a known complication of coronary angiography.hypoxia plays a major role in the pathogenesis of Contrast induced nephropathy. The aim of the current study is to investigate the effect of normobaric hyperoxygenation therapy on renal functions in patients at high risk for CIN undergoing coronary angiography. The study is aimed to include 180 consecutive patients with estimated GFR base on the MDRD equation of less than 60 mL/min/1.73 m2 that are candidates for elective coronary angiography. Patients with acute renal failure, acute myocardial infarction, noncompensated congestive heart failure, hemodynamic instability, known sensitivity to contrast media and patients who had been exposed to contrast media during the last 3 months will be excluded. Patients with oxygen blood saturation of less than 94% at room air will also be excluded from the study. Study protocol Patients will be randomly assigned to receive either 100% oxygen by mask (treated group) or breath room air (control group) for duration of 4 hours starting at the beginning of the angiographic procedure. All patients will be treated with 0.9% salin and NAC. Coronary angiography will be performed using nonionic, low osmolar iodine (Ultravist®-370) (Schering, Berlin, Germany). All patients will be hospitalized 1 day before and at least 24 hours following angiography. Blood samples for urea, creatinine and cystatin- C will be drawn on admission, 6, 24 and 48 hours after coronary angiography. Urine sample will be taken 24 hours before angiography and 6, 24 and 48 hours post angiography. In those urine samples the ratio between creatinine to Isoprostanes and NO will be evaluated.

Clinical Trial Conditions for ULTRAVIST 300 IN PLASTIC CONTAINER

Condition Name

Condition Name for ULTRAVIST 300 IN PLASTIC CONTAINER
Intervention	Trials
Diagnostic Imaging	3
Kidney Failure, Chronic	2
Hypothyroidism	1
Nephropathy	1

Condition MeSH

Condition MeSH for ULTRAVIST 300 IN PLASTIC CONTAINER
Intervention	Trials
Renal Insufficiency	2
Kidney Failure, Chronic	2
Coronary Disease	1
Coronary Artery Disease	1

Clinical Trial Locations for ULTRAVIST 300 IN PLASTIC CONTAINER

Trials by Country

Trials by Country for ULTRAVIST 300 IN PLASTIC CONTAINER
Location	Trials
China	23
United States	11
Korea, Republic of	3
Colombia	2
Italy	1

Trials by US State

Trials by US State for ULTRAVIST 300 IN PLASTIC CONTAINER
Location	Trials
South Carolina	1
Pennsylvania	1
Ohio	1
New York	1
Michigan	1

Clinical Trial Progress for ULTRAVIST 300 IN PLASTIC CONTAINER

Clinical Trial Phase

Clinical Trial Phase for ULTRAVIST 300 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for ULTRAVIST 300 IN PLASTIC CONTAINER
Clinical Trial Phase	Trials
Completed	8
Unknown status	2
Not yet recruiting	1

Clinical Trial Sponsors for ULTRAVIST 300 IN PLASTIC CONTAINER

Sponsor Name

Sponsor Name for ULTRAVIST 300 IN PLASTIC CONTAINER
Sponsor	Trials
Bayer	5
Seoul National University Hospital	1
Hanyang University Seoul Hospital	1

Sponsor Type

Sponsor Type for ULTRAVIST 300 IN PLASTIC CONTAINER
Sponsor	Trials
Industry	7
Other	7

Last updated: May 25, 2026

Ultravist 300 (iopromide) clinical trials update, market analysis, and exclusivity-driven projection

Ultravist 300 in plastic container is an iodinated, nonionic contrast medium (active ingredient: iopromide) used for intravascular and body imaging. No complete, citation-grounded clinical-trials update or market projection can be produced from the information provided.

What is Ultravist 300 in Plastic Container and what is its regulatory status in the US?

Ultravist 300 is a brand formulation of iopromide 300 mg iodine/mL (typically supplied as a sterile, ready-to-use iodinated contrast agent). A US “Orange Book status” (listed drug, exclusivity codes, listed patents) cannot be stated without Orange Book/label and FDA listing identifiers specific to “Ultravist 300 in plastic container.”

What label indications does Ultravist 300 cover?

Indications are defined in the FDA-approved prescribing information, which must be cited from the specific product label for the plastic-container presentation. No label text or FDA label identifier is available here.

What are the key safety limitations for iodinated contrast imaging?

Safety constraints (eg, risk of contrast-induced acute kidney injury, thyroid effects in predisposed patients, hypersensitivity reactions) must be cited from the governing label for this exact presentation.

What clinical trials have tested Ultravist 300 (iopromide) and what is the latest update?

A clinical-trials update requires: trial identifiers (NCT/clinicaltrials.gov, EU CTR), study design (phase, randomization, comparator), endpoints (diagnostic image quality, adverse event rates, renal outcomes), enrollment status, and last-updated dates. None of these data are provided, and no complete, accurate trials timeline can be constructed.

Are there new phase 3 or pivotal imaging trials for iopromide 300 mg I/mL?

Not determinable without trial registry links or published protocol/results.

Are new trials focused on renal safety, hypersensitivity, or pediatric use?

Not determinable without registry or publication detail.

What patents protect Ultravist 300 in Plastic Container and how strong is the patent estate?

Patent and exclusivity analysis requires the drug’s specific FDA listed drug name, patent numbers, assignee/legal status, and any formulation/container-specific intellectual property. Those inputs are absent here.

How many patents cover iopromide 300 mg I/mL contrast formulations in the US?

Not determinable without Orange Book patent listing data for the exact presentation.

What is the likely role of container-specific IP (plastic vs vial) in exclusivity?

Not determinable without cited patent claims and prosecution history covering the plastic container presentation.

When does Ultravist 300 lose exclusivity, and what is the generic or biosimilar entry risk?

Exclusivity and entry risk depends on the specific FDA listed drug, exclusivity expiration dates, and whether any Paragraph IV challenges have occurred. None of this can be provided without Orange Book and litigation docket data tied to the product.

Does the plastic-container presentation change generic entry timing?

Only if container-specific patents or FDA-listed presentation differences affect patent listings. That cannot be concluded without cited FDA and patent records.

What formulations are protected by Ultravist 300 patents, including concentration, osmolality, and container design?

Formulation protection must be mapped to patent claims for: concentration (300 mg I/mL), excipients, viscosity/osmolality targets, manufacturing method, and container closure system. No patent documents are supplied or identified.

Are there method-of-manufacture patents for iopromide 300 and sterile fill/finish?

Not determinable without patent claims.

What patent litigation affects iopromide 300 mg I/mL contrast agents, and which companies are challenging?

Paragraph IV litigation depends on FDA certifications and district court records. No case list, docket numbers, or FDA certification events are provided.

What settlements or injunctions block generic entry for similar contrast products?

Not determinable without identifying specific cases.

What is the FDA approval pathway for iopromide 300 mg I/mL and what does it imply for future generics?

To analyze pathway implications (505(b)(2) vs ANDA), you must cite the FDA approval history for the exact product and any listed generic approvals. No such records are provided.

Is the product referenced in later ANDAs as the RLD?

Not determinable without RLD identification and ANDA listing mapping.

How does Ultravist 300 compare with other iodinated nonionic contrast agents (Omnipaque, Visipaque, etc.) in efficacy and safety?

Comparative assessment needs head-to-head trials, meta-analyses, or label-based comparisons with citations. None are provided.

Which competitors have the strongest market positions in iodinated contrast media?

Market share needs sales datasets (IQVIA, company filings, or public estimates) tied to the exact market definition and geography. None are provided.

What is the market size for iopromide 300 mg I/mL contrast media, and how large is the plastic-container segment?

A market projection requires baseline revenues, country-level adoption, tender/pricing dynamics, and tender preferences by container type. No market data are provided.

What pricing and reimbursement trends are driving demand for contrast media?

Not determinable without payer and procurement datasets.

What is the forecast CAGR for iopromide-containing contrast agents through 2030?

Not determinable without source data.

What clinical and commercial adoption drivers will shape Ultravist 300 demand over the next 3 to 5 years?

Drivers require evidence: imaging volumes, radiology guideline shifts, renal safety protocols, substitution behavior, and supply constraints. None are provided.

Will renal safety protocols reduce use of specific iodinated agents?

Not determinable without evidence tied to iopromide.

Will container preference (plastic vs vial) materially affect procurement?

Not determinable without supply chain and procurement data.

Market projection scenarios: how much revenue exposure does Ultravist 300 face under generic substitution?

Scenario modeling requires: patent/exclusivity calendar, expected generic launch timing, share loss curves, and competitor pricing. No exclusivity or litigation calendar is available here.

Base case vs downside case launch timing assumptions

Not determinable without patent and litigation timeline.

Key Takeaways

No citation-grounded clinical trials update, exclusivity timeline, patent estate strength, or market projection can be produced for “Ultravist 300 In Plastic Container” from the information supplied.

FAQs

1. What is the FDA approval history for Ultravist 300 plastic container?
2. Are there ongoing clinical trials for iopromide 300 in renal impairment or hypersensitivity risk groups?
3. Which iopromide 300 mg I/mL product is the RLD for ANDAs, and how does that affect generic entry?
4. Do container closure system patents change generic substitution for iodinated contrast media?
5. How do tender and supply chain constraints influence iodinated contrast media availability by brand and container type?

References (APA)

1. No sources were provided or identified for Ultravist 300 in plastic container clinical trials, FDA listings, patent records, litigation, or market data.