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
- What is the FDA approval history for Ultravist 300 plastic container?
- Are there ongoing clinical trials for iopromide 300 in renal impairment or hypersensitivity risk groups?
- Which iopromide 300 mg I/mL product is the RLD for ANDAs, and how does that affect generic entry?
- Do container closure system patents change generic substitution for iodinated contrast media?
- How do tender and supply chain constraints influence iodinated contrast media availability by brand and container type?
References (APA)
- No sources were provided or identified for Ultravist 300 in plastic container clinical trials, FDA listings, patent records, litigation, or market data.
