Last updated: August 5, 2026
Ultravist 300 in plastic container is a presentation of iopromide, a nonionic, low-osmolar iodinated contrast medium marketed by Bayer. Its commercial outlook is driven by radiology procedure volumes, hospital purchasing contracts, supply reliability, packaging economics, and competition from established agents such as iohexol, iopamidol, and iodixanol. Bayer does not publicly report revenue for Ultravist 300 or for the plastic-container presentation separately, so product-level financial performance cannot be calculated from public filings.
What is Ultravist 300 in plastic container?
Ultravist 300 contains iopromide at an iodine concentration of 300 mg iodine/mL. The product is administered intravenously or intra-arterially for contrast enhancement during computed tomography, digital subtraction angiography, intra-arterial digital subtraction angiography, and other approved imaging procedures, subject to the applicable national label.
The "plastic container" designation identifies the packaging presentation rather than a separate active ingredient, formulation, or new molecular entity. Commercial units generally compete on dose volume, ease of handling, compatibility with power injectors, waste reduction, and total procurement cost.
| Attribute |
Ultravist 300 in plastic container |
| Active ingredient |
Iopromide |
| Strength |
300 mg iodine/mL |
| Drug class |
Nonionic, low-osmolar iodinated contrast medium |
| Primary use |
X-ray and CT contrast enhancement |
| Originator |
Bayer |
| Dosage form |
Sterile injectable solution |
| Commercial differentiation |
Container format, supply, handling, contracting, and service |
| FDA pathway |
Prescription drug approved under an NDA |
| Product-level revenue disclosure |
Not separately reported by Bayer |
FDA labeling identifies iopromide as a nonionic contrast agent used in several diagnostic imaging applications and describes warnings involving hypersensitivity reactions, acute kidney injury, extravasation, thyroid dysfunction, and other risks associated with iodinated contrast media. [1]
What is the FDA regulatory status of Ultravist 300?
Ultravist is an established FDA-approved iodinated contrast product. Its regulatory value comes from clinical approval, manufacturing compliance, quality controls, and hospital formulary acceptance rather than from market exclusivity associated with a recently launched drug.
The product’s regulatory position has four commercial implications:
- Hospitals can use it within established radiology protocols.
- Substitution decisions are generally controlled by formularies, radiology departments, group purchasing organizations, and purchasing contracts.
- The product competes in a mature therapeutic category with multiple approved contrast agents.
- Regulatory compliance and supply continuity can matter as much as brand preference.
The plastic-container presentation may be listed as a separate package configuration in product databases, but that does not necessarily create separate regulatory exclusivity. The approved active ingredient remains iopromide.
Does Ultravist 300 have FDA exclusivity?
Ultravist 300 is not commercially protected by the type of new-drug exclusivity typically associated with a recent FDA launch. Any remaining commercial protection would depend on listed patents, formulation claims, manufacturing claims, regulatory data rights, trademarks, and contract economics. For an older small-molecule contrast agent, patent exclusivity is unlikely to be the main barrier to competition.
When does Ultravist 300 lose exclusivity?
Ultravist’s core product exclusivity has already matured beyond the period normally associated with a new chemical entity. The key commercial issue is therefore not a single future loss-of-exclusivity date. It is the degree of generic and branded competition already present in the iodinated contrast market.
| Exclusivity factor |
Commercial assessment |
| New chemical entity exclusivity |
Historical, not a current growth driver |
| Core composition-of-matter patent |
Expected to be expired or commercially immaterial |
| Plastic-container protection |
Packaging claims alone are unlikely to block substitution |
| Method-of-use protection |
Limited value where procedures and contrast protocols are established |
| Regulatory exclusivity |
Not expected to create a meaningful current barrier |
| Trademark protection |
Protects the Ultravist name, not iopromide competition |
| Manufacturing know-how |
Can support quality and supply but does not necessarily prevent entry |
A definitive Orange Book patent conclusion requires a current FDA Orange Book record for the relevant NDA and package. Bayer’s public annual reporting does not provide a product-specific patent schedule for Ultravist 300.
What is the Orange Book status of Ultravist 300?
The Orange Book analysis must be performed at the NDA and package level, not solely by searching the trade name. Ultravist presentations may have different package codes, strengths, and labeling histories. An Orange Book listing may identify the reference product and any patents that remain listed for the applicable NDA.
For commercial diligence, the relevant questions are:
- Whether the specific iopromide product has an active reference-listed drug entry.
- Whether any patents are listed for the 300 mg iodine/mL presentation.
- Whether a generic applicant has filed an abbreviated new drug application.
- Whether a Paragraph IV certification has been filed.
- Whether Bayer has initiated litigation within the statutory period.
- Whether any 30-month stay or settlement affects launch timing.
No product-specific Paragraph IV case or settlement should be attributed to Ultravist 300 without confirmation from FDA records and federal court dockets. The product’s age and mature competitive category reduce the likelihood that patent litigation, rather than regulatory approval or manufacturing, will determine market entry.
Which companies compete with Ultravist 300?
Ultravist 300 competes against both direct iopromide products and alternative iodinated contrast media. Hospitals often evaluate these products as part of a category-wide purchasing decision.
| Competitive group |
Representative products |
Competitive basis |
| Iopromide |
Ultravist and potential generic equivalents |
Same active ingredient, concentration, protocols, and supply |
| Iohexol |
Omnipaque, GE HealthCare |
Broad installed base and hospital familiarity |
| Iopamidol |
Isovue, Bracco |
Established radiology use and contracting |
| Iodixanol |
Visipaque, GE HealthCare |
Isotonic formulation and selected clinical preferences |
| Ioxilan |
Oxilan and related products |
Alternative low-osmolar contrast option |
| Other iodinated agents |
Region-specific products |
Price, availability, and local procurement |
The principal competitors are GE HealthCare and Bracco, with regional generic and contract manufacturers contributing to price pressure. Product selection is influenced by concentration, indication, injector compatibility, prior protocol standardization, adverse-event experience, and supply performance.
How does Ultravist 300 compare with Omnipaque and Isovue?
Ultravist 300 has no clear structural market advantage based solely on its 300 mg iodine/mL concentration. Iohexol and iopamidol are similarly established low-osmolar agents. Iodixanol may be selected for specific clinical or institutional reasons despite a higher acquisition cost in some markets.
| Factor |
Ultravist 300 |
Omnipaque |
Isovue |
| Active ingredient |
Iopromide |
Iohexol |
Iopamidol |
| Typical category |
Low-osmolar nonionic |
Low-osmolar nonionic |
Low-osmolar nonionic |
| 300 concentration availability |
Yes |
Yes |
Yes |
| Main advantage |
Established Bayer product and supply platform |
Broad clinical adoption |
Established Bracco contracting position |
| Main weakness |
Mature category and substitution risk |
Competitive pricing pressure |
Competitive pricing pressure |
| Switching barrier |
Protocol familiarity and contracts |
Protocol familiarity and contracts |
Protocol familiarity and contracts |
Clinical interchangeability is not automatic in every institutional protocol, but the category has a high degree of practical substitutability. This limits pricing power.
What drives the market for Ultravist 300?
Radiology procedure volumes
Demand tracks CT, angiography, interventional radiology, and other contrast-enhanced procedures. Imaging volumes can rise with an aging population, cancer diagnosis, cardiovascular disease, emergency care, and outpatient imaging growth.
The relationship is not one-to-one. Dose optimization, lower-volume protocols, renal-risk screening, and changes in imaging practice can reduce contrast consumption per procedure.
Hospital purchasing contracts
Large hospitals and health systems frequently purchase contrast media through negotiated agreements. Group purchasing organizations can compress net prices and favor suppliers able to provide multi-site delivery, injector integration, and reliable inventory.
The winning supplier may be selected on total cost rather than list price. Relevant variables include:
- Unit price by vial or syringe.
- Container size and fill efficiency.
- Contrast waste.
- Delivery charges.
- Automated injector compatibility.
- Inventory requirements.
- Product availability during shortages.
- Contract rebates and administrative fees.
Supply reliability
Iodinated contrast supply disruptions have demonstrated that hospitals may favor a supplier with dependable manufacturing and distribution, even when a competing product has a lower nominal price. A plastic container can support workflow efficiency, but it also creates dependence on container components, sterilization capacity, and packaging-line throughput.
Packaging economics
Plastic containers may reduce breakage risk and improve handling compared with glass in certain settings. The financial impact depends on container cost, shipping weight, storage density, injector workflow, and disposal requirements. Packaging is unlikely to support a durable premium unless it produces measurable labor or waste savings.
What is the financial trajectory for Ultravist 300?
Bayer reports its business through broader pharmaceutical and regional categories. It does not disclose revenue, gross margin, units, or operating profit for Ultravist 300 in plastic container as a standalone product. Any numerical product-revenue estimate would therefore be model-derived rather than company-reported.
The likely trajectory is mature-to-declining in nominal pricing, with volume stability dependent on imaging demand and contract retention.
| Financial driver |
Expected effect |
| Procedure-volume growth |
Supports unit demand |
| Generic or regional competition |
Reduces price and share |
| Hospital contract renewals |
Determines net price and retention |
| Supply disruptions |
Can cause temporary volume gains or losses |
| Plastic-container efficiency |
May protect account economics |
| Bayer portfolio rationalization |
Could affect investment and distribution |
| Contrast-media shortages |
Increase value of reliable supply |
| Product substitution |
Limits long-term pricing power |
Base-case trajectory
The base case is stable demand with declining net prices. Ultravist 300 can retain meaningful volume where Bayer has strong hospital contracts, established protocols, and reliable supply. Revenue is likely to face gradual erosion unless procedure growth offsets price reductions.
Upside scenario
An upside case would require sustained growth in contrast-enhanced imaging, favorable contract renewals, supply shortages affecting competitors, or stronger demand for the plastic presentation. These factors could improve volume and realized pricing temporarily.
Downside scenario
The downside case involves generic iopromide availability, aggressive discounting by GE HealthCare or Bracco, loss of major group purchasing contracts, manufacturing disruption, or accelerated switching to alternative contrast media. In a mature market, share loss can occur quickly after a hospital changes its formulary or primary supplier.
How strong is the patent estate for Ultravist 300?
The patent estate appears commercially weak relative to newer specialty pharmaceuticals because iopromide is an established small molecule with a long market history. The main sources of defensibility are operational rather than patent-based:
- Validated manufacturing processes.
- Regulatory compliance history.
- Supply-chain scale.
- Hospital protocol integration.
- Brand familiarity.
- Contracting capability.
- Quality and pharmacovigilance systems.
Packaging patents, if any exist for a particular container design, would generally have limited ability to block alternative containers or competing iopromide products. Method-of-use patents would also face practical limitations because CT and angiographic applications are mature and broadly practiced.
What generic entry risks exist for Ultravist 300?
Generic entry risk is moderate to high at the category level and depends on the availability of an approved iopromide equivalent in each jurisdiction. The primary risks are price compression and formulary substitution, not a sudden loss of the entire market.
A generic entrant would need to demonstrate pharmaceutical equivalence and satisfy applicable FDA quality and manufacturing requirements. Commercial success would then depend on:
- FDA approval and launch timing.
- Ability to manufacture sterile injectable product at scale.
- Container and presentation compatibility.
- Reliable supply during demand peaks.
- Contract access.
- Pricing below branded net prices.
- Hospital willingness to switch protocols.
Sterile injectable manufacturing is a meaningful operational barrier. It can slow entry and limit the number of credible suppliers, even when composition-of-matter patents have expired.
What patent litigation and Paragraph IV risks affect Ultravist 300?
No specific Paragraph IV challenge, patent settlement, or active federal litigation should be treated as affecting Ultravist 300 without a current docket and FDA-record review. The likely legal risk profile is lower than for recently launched branded drugs because:
- The active ingredient is old.
- The principal clinical uses are established.
- Packaging differentiation is limited.
- Hospital buyers can evaluate several competing contrast agents.
- The commercial bottleneck is often sterile manufacturing and contracting.
If a new iopromide ANDA is filed with a Paragraph IV certification, the principal legal questions would involve any listed formulation, container, manufacturing, or use claims, followed by the timing of a 30-month stay and any settlement restrictions.
What manufacturing and intellectual-property barriers matter most?
Manufacturing execution is more important than patent exclusivity. Iopromide is a sterile injectable product that requires validated synthesis, impurity control, aseptic processing, container-closure integrity, particulate control, and reliable quality-release testing.
The plastic container adds requirements involving:
- Extractables and leachables.
- Container-closure integrity.
- Material compatibility with iopromide solution.
- Sterilization and packaging validation.
- Transport durability.
- Injector performance.
- Stability throughout shelf life.
These controls can create real entry barriers, but they are not equivalent to long-term patent protection. A capable generic manufacturer can overcome them through investment, validation, and regulatory approval.
What is the geographic market outlook for Ultravist 300?
The United States, Europe, Japan, China, and other developed markets have mature contrast-media infrastructure. Geographic performance varies with reimbursement, imaging utilization, procurement concentration, local competitors, and regulatory approvals.
Bayer’s global position provides distribution scale, but local tender systems can reduce brand advantage. Emerging markets may offer higher procedure growth while producing lower realized prices. Currency movements and government procurement can materially affect reported sales even when unit demand is stable.
Key Takeaways
- Ultravist 300 in plastic container is a packaging presentation of iopromide, not a distinct active ingredient.
- Bayer does not publicly disclose product-level revenue or profitability for this presentation.
- The product is in a mature market with limited current patent-based exclusivity.
- Competitive pressure comes from iohexol, iopamidol, iodixanol, other iodinated agents, and potential generic iopromide products.
- Hospital contracts, supply reliability, and sterile injectable manufacturing are more important than patent duration.
- The most likely financial trajectory is stable-to-declining revenue, driven by procedure growth offset by price erosion.
- A current Orange Book, ANDA, Paragraph IV, and litigation review is required before assigning a specific legal launch date.
- Plastic packaging can improve workflow and handling economics but is unlikely to create durable market exclusivity.
FAQs About Ultravist 300 in Plastic Container
Is Ultravist 300 the same as iopromide?
Yes. Ultravist 300 is a branded presentation of iopromide at 300 mg iodine/mL.
Can hospitals substitute another 300 mg iodine/mL contrast agent?
Hospitals may use alternative agents, but substitution must follow institutional protocols, formulary decisions, labeling requirements, and clinical judgment.
Does the plastic container give Ultravist 300 patent protection?
Packaging may be covered by specific intellectual-property rights, but the container presentation alone is unlikely to prevent competing iopromide or alternative contrast products.
Why might Bayer retain sales after patent expiry?
Brand retention can result from hospital contracts, established imaging protocols, supply reliability, manufacturing quality, and distribution scale.
What is the largest financial risk to Ultravist 300?
The largest risk is sustained net-price erosion caused by hospital tendering, generic competition, and substitution among established iodinated contrast media.
References
- U.S. Food and Drug Administration. (2023). Ultravist- iopromide injection prescribing information. Bayer HealthCare Pharmaceuticals Inc. https://www.accessdata.fda.gov
- U.S. Food and Drug Administration. (2024). Orange Book: Approved drug products with therapeutic equivalence evaluations. https://www.accessdata.fda.gov/scripts/cder/ob/
- Bayer AG. (2024). Annual report 2023. https://www.bayer.com/en/investors/financial-reports
- U.S. Food and Drug Administration. (2024). Drug shortages: Iodinated contrast media. https://www.fda.gov/drugs/drug-safety-and-availability/drug-shortages
- American College of Radiology. (2024). ACR manual on contrast media. https://www.acr.org/Clinical-Resources/Contrast-Manual
