Last Updated: July 17, 2026

ULTRAVIST 300 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Ultravist 300 patents expire, and what generic alternatives are available?

Ultravist 300 is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in ULTRAVIST 300 is iopromide. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the iopromide profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for ULTRAVIST 300?
  • What are the global sales for ULTRAVIST 300?
  • What is Average Wholesale Price for ULTRAVIST 300?
Recent Clinical Trials for ULTRAVIST 300

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Duke Clinical Research InstitutePhase 4
GE HealthcarePhase 4
BayerPhase 4

See all ULTRAVIST 300 clinical trials

Pharmacology for ULTRAVIST 300

US Patents and Regulatory Information for ULTRAVIST 300

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bayer Hlthcare ULTRAVIST 300 iopromide INJECTABLE;INJECTION 020220-002 May 10, 1995 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare ULTRAVIST 300 IN PLASTIC CONTAINER iopromide INJECTABLE;INJECTION 020220-005 Nov 18, 2008 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for ULTRAVIST 300

See the table below for patents covering ULTRAVIST 300 around the world.

Country Patent Number Title Estimated Expiration
Austria 1061 ⤷  Start Trial
Australia 529565 ⤷  Start Trial
Australia 5627280 ⤷  Start Trial
Canada 1130316 DIAMIDES D'ACIDE ISOPHTALIQUE TRI-IODES UTILISES COMME AGENTS DE CONTRASTE NON IONIQUES POUR RAYONS X (TRI-IODATED ISOPHTHALIC ACID DIAMIDES AS NON-IONIC X-RAY CONTRAST AGENTS) ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration
Last updated: June 16, 2026

ULTRAVIST 300 market dynamics and financial trajectory: demand, pricing pressure, channel mix, and exclusivity-driven risk

ULTRAVIST 300 (iopromide) has shifted from a prescription-volume story to a procurement and hospital formulary story as utilization depends on radiology volume, payer procurement, and contract pricing. Financial trajectory is shaped by (1) the cross-class competition from alternative nonionic, iodinated contrast media (ICMs), (2) pressure from national and group-purchasing agreements, and (3) the absence of durable, wide-ranging protection that blocks generics/biosimilars-type substitution for small-molecule ICMs. Short-cycle demand volatility tracks imaging procedure volumes and hospital budget cycles, while pricing is dominated by tender dynamics rather than patent-linked price premium.

Core market drivers

  • Imaging volume: CT and interventional radiology case volumes drive exposure. Increases in CT utilization generally lift demand; temporary downshifts (capacity constraints, diagnostic deferrals, reimbursement changes) reduce it.
  • Hospital purchasing: ICMs are commonly awarded via tenders with multi-vendor contracts; ULTRAVIST 300 pricing behaves like a commodity product relative to patented specialty drugs.
  • Substitution risk: Iopromide products compete against other iodinated contrast brands and multiple sourced generics with similar therapeutic equivalence.

Core market constraints

  • Pricing compression: tender-based reimbursement and competitive procurement lead to net price erosion.
  • Regulatory and safety governance: contrast administration protocols, kidney-injury mitigation pathways, and facility credentialing influence formulary decisions but rarely create product-specific lock-in at scale.

What is ULTRAVIST 300, who buys it, and how does that shape revenue?

ULTRAVIST 300 is an iodinated, nonionic contrast agent (active ingredient: iopromide) used for radiographic imaging, most prominently CT. Demand is primarily institutional.

Customer segmentation that drives sales

  • Hospitals and imaging centers: dominant purchasers via group purchasing organizations (GPOs) and institutional tenders.
  • Specialty outpatient clinics: smaller share, usually tied to local contracts and stock management.
  • National health systems (where applicable): procurement tenders drive pricing floors and vendor swaps.

Channel mix mechanics

  • High-throughput settings (ED, inpatient imaging, oncology staging) tend to prefer standardized supply contracts. That structure reduces reorder friction but accelerates price renegotiation.
  • Smaller outpatient sites are more sensitive to shelf availability and contract coverage, creating episodic volume swings when a vendor loses a tender.

How do market dynamics affect ULTRAVIST 300 pricing and gross margin?

Ultravist 300’s financial path is governed by net price realization, not list price.

Pricing levers

  • Tender award price and volume tiers: annual or multi-quarter contracting with tiered rebates.
  • Substitution elasticity: procurement teams can switch among equivalent nonionic ICMs if clinical protocols remain satisfied.
  • Formulary access: losing “preferred” status forces higher procurement friction and reduced utilization.

Typical margin exposure in this category

  • Higher cost of goods to meet packaging, sterility assurance, and supply reliability can compress margin if procurement shifts toward lowest-cost awarded suppliers.
  • Revenue mix can shift between vial sizes and pack configurations based on tender terms. That affects conversion rates for inventory replenishment and can alter effective gross margins.

What competitors pressure ULTRAVIST 300, and how does competition change the financial trajectory?

Competition in nonionic iodinated contrast media is dense. ULTRAVIST 300 competes on procurement economics and dosing flexibility rather than patent-protected differentiation.

Competitive set (category-level)

ULTRAVIST 300 (iopromide) competes with other iodinated nonionic agents used for the same imaging purposes, including:

  • iohexol-based agents (e.g., Omnipaque-related products)
  • ioversol-based agents
  • iodixanol-based agents
  • iomeprol-based agents
  • iodinated contrast generics and sourced equivalents across multiple brands and pack sizes

How competitive pressure typically manifests

  • Net price erosion after a tender reassignment.
  • Volume share transfers when alternative agents win “preferred” status under new contracting.
  • Promotional and contract support increases once a vendor is at risk of losing formulary access.

When does ULTRAVIST 300 lose exclusivity, and what does that imply for revenue?

For small-molecule iodinated contrast agents, the revenue center of gravity tends to move away from patent exclusivity and toward procurement cycles once generic/sourced equivalents are available.

Exclusivity-driven risk pattern

  • If ULTRAVIST 300 is fully or largely exposed to generic substitution, revenue trajectory reflects contracting cycles.
  • Even without a clean “patent cliff” narrative, the practical effect is similar: sustained market share pressure and net price reductions once equivalents are widely listed.

Resulting implication for financial trajectory: the product typically experiences a gradual decline or plateau in revenue, with sharp drops tied to tender loss events rather than a single, date-based exclusivity expiration.


How many patents cover ULTRAVIST 300, and how strong is the patent estate for stopping competition?

For iodinated contrast media like iopromide, patent estates often concentrate in specific jurisdictions, specific formulations, packaging, or process improvements rather than broad method-of-use exclusivity.

Patent estate dynamics that matter commercially

  • If protection is narrow (e.g., process, formulation, specific container), competitors can launch around with sourced equivalents.
  • If protection is broad but older, exclusivity typically erodes over time and does not withstand multi-source procurement.

Business implication: in a tender-driven category, even moderately narrow patent coverage often has limited power to defend net revenue once equivalent products are routinely stocked.


What patent litigation affects ULTRAVIST 300 and similar iopromide products?

In most iodinated contrast media segments, high-stakes litigation is less common than in branded specialty drugs because competition often occurs via sourced equivalents and procurement. Litigation, when it occurs, tends to focus on formulation, manufacturing, or packaging.

Commercial impact if litigation is present

  • A supplier’s ability to contract can be disrupted if injunction risk arises, but litigation outcomes usually do not extend indefinitely across multiple jurisdictions.
  • Practical effect: litigation is episodic and more likely to shape procurement availability for a period than to permanently reshape market structure.

What is the Orange Book status of ULTRAVIST 300 and what does that mean for generic entry risk?

ULTRAVIST 300 is a small-molecule drug, so the relevant exclusivity and generic entry risk typically maps to ANDA listings, listed patents (if any), and expiration dates.

Business-relevant interpretation:

  • If ULTRAVIST 300 is listed in the FDA Orange Book with patents that have expired, generic entry risk is structurally high.
  • If patents are listed but narrow, generic launch risk remains elevated because launchers can often design around.

What FDA regulatory pathway and labeling factors drive ULTRAVIST 300 substitution?

Label and equivalence mechanics

  • Imaging indications and administration protocols typically require that an alternative agent meets comparable performance and safety criteria.
  • Substitution is facilitated when alternative products have comparable dosing guidance and interchangeability in practice.

Facility protocol factors

  • Radiology departments standardize contrast protocols and may adopt preferred agents based on procurement pricing and internal outcomes review.
  • Once protocols are updated for alternative products, volume can shift quickly at contract renewal.

How do settlement agreements and exclusivity periods affect ULTRAVIST 300 launches?

In the ICM space, settlements are often contract- and jurisdiction-specific. When settlements exist, they usually:

  • define a launch date or trigger supply commitments,
  • restrict certain claims or marketing representations,
  • and can include supply arrangements that temporarily stabilize revenue.

Financial trajectory implication: any stabilization tends to be temporary and tied to the settlement’s duration and scope.


How do formulary decisions and hospital tender cycles impact ULTRAVIST 300 revenue over time?

Tender cadence and revenue timing

  • Annual or quarterly tender cycles create step-function changes in net revenue.
  • Products can show revenue drops or rebounds around contract award dates.

Procurement criteria

  • Net cost after rebates
  • Packaging preference (vial sizes, kit compatibility)
  • Supply reliability and lead times
  • Clinical acceptance within institutional protocols

Revenue pattern expectation: a plateau with periodic step changes rather than smooth, patent-driven growth curves.


What financial trajectory should investors expect for ULTRAVIST 300: growth, decline, or plateau?

Given the category structure, the most common financial trajectory for brands of iopromide and similar ICMs is:

  • plateau or gradual decline in unit demand share as equivalents compete,
  • continuing volatility around tender outcomes,
  • net price compression over time,
  • and possible re-stabilization if a brand wins preferred status within large purchasing groups.

What to track for actual trajectory

  • Net revenue by quarter tied to contract renewals
  • Gross-to-net movement (rebates, chargebacks)
  • Hospital purchasing concentration (GPO share and large-account penetration)
  • Mix shifts by pack size (impact on unit economics)

How does ULTRAVIST 300 compare with other iodinated contrast agents financially and competitively?

Relative competitive position

Brands with entrenched institutional relationships can retain share even under pricing pressure, but price elasticity remains high. Agents that win preferred tenders often capture disproportionate share because procurement consolidates volume to limit ordering complexity.

What drives outperformance versus peers

  • Strong contract coverage across large GPOs
  • Reliable supply and lead times
  • Alignment with radiology protocol preferences
  • Better pack-size compatibility for facility dosing workflows

Net effect: financial trajectory tends to be contract- and channel-driven, not scientific exclusivity driven.


Key Takeaways

  • ULTRAVIST 300 revenue is primarily shaped by hospital procurement tender cycles, rebate structures, and substitution economics in nonionic iodinated contrast media.
  • Competitive pressure and generic/sourced-equivalent availability typically push the product toward net price compression and plateau/gradual share erosion rather than long-run premium pricing.
  • The “financial trajectory” pattern in this category is stepwise volatility around contract awards, not a single exclusivity expiration event.
  • Patent strength and Orange Book status matter, but in iodinated contrast media they often translate into limited incremental protection versus broad procurement substitution once equivalents are available.

FAQs

  1. How quickly can hospitals switch ULTRAVIST 300 to another iodinated contrast agent after a tender?
    Typically at the next procurement cycle once protocols and inventory are aligned, with timing tied to contract award dates and formulary committee approvals.

  2. Do pack size and vial configuration materially affect ULTRAVIST 300 revenue?
    Yes. Tender terms often specify preferred pack formats, and mixing shifts changes unit economics and net price realization.

  3. What procurement metrics drive ULTRAVIST 300 contract wins versus alternative iopromide or nonionic ICMs?
    Net cost after rebates, supply reliability, and compatibility with dosing workflows and existing radiology protocols.

  4. What Orange Book signals best predict generic erosion risk for ULTRAVIST 300?
    Expired listed patents and broad availability of ANDA equivalents, which correlate with high substitution probability in tender-driven institutional markets.

  5. Does litigation meaningfully protect ULTRAVIST 300 revenue in the long term?
    Usually not. Any protection tends to be temporary and limited to specific jurisdictions or product attributes, while procurement competition continues through alternatives.


References

No sources were provided in the prompt.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.