Last Updated: July 17, 2026

ULTRAVIST (PHARMACY BULK) Drug Patent Profile


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Which patents cover Ultravist (pharmacy Bulk), and when can generic versions of Ultravist (pharmacy Bulk) launch?

Ultravist (pharmacy Bulk) is a drug marketed by Bayer Hlthcare and is included in one NDA.

The generic ingredient in ULTRAVIST (PHARMACY BULK) 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.

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  • What is the 5 year forecast for ULTRAVIST (PHARMACY BULK)?
  • What are the global sales for ULTRAVIST (PHARMACY BULK)?
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Summary for ULTRAVIST (PHARMACY BULK)
Recent Clinical Trials for ULTRAVIST (PHARMACY BULK)

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

SponsorPhase
GE HealthcarePhase 4
BayerPhase 4
Guerbet/Liebel-FlarsheimPhase 4

See all ULTRAVIST (PHARMACY BULK) clinical trials

US Patents and Regulatory Information for ULTRAVIST (PHARMACY BULK)

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 (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-003 Mar 12, 2004 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-001 Sep 20, 2002 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-002 Sep 20, 2002 RX Yes Yes ⤷  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

Expired US Patents for ULTRAVIST (PHARMACY BULK)

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-003 Mar 12, 2004 4,364,921 ⤷  Start Trial
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-002 Sep 20, 2002 4,364,921 ⤷  Start Trial
Bayer Hlthcare ULTRAVIST (PHARMACY BULK) iopromide INJECTABLE;INJECTION 021425-001 Sep 20, 2002 4,364,921 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Last updated: July 12, 2026

ULTRAVIST (Pharmacy Bulk) market dynamics and financial trajectory: pricing, volume drivers, competitive pressure, and exclusivity-to-generic outlook

ULTRAVIST (iopromide) is an iodinated contrast media product used in diagnostic imaging. Because the formulation is an off-patent, widely supplied category drug and ULTRAVIST “pharmacy bulk” is not a branded manufacturer distribution model that maps cleanly to a single FDA NDA product with a transparent revenue line, public financials are not traceable to ULTRAVIST “pharmacy bulk” as a distinct revenue pool. Under that constraint, the market trajectory is best modeled at the class level: stable demand tied to imaging procedure volumes, pricing pressure from biosimilar-like substitution does not apply, but generic/alternate contrast competition and contracting dynamics do.

What to expect financially (directionally):

  • Revenue stability, then margin compression as buyers shift from branded or single-source contracting toward multi-source tendering across iodinated contrast media.
  • No step-change from patent expiration on ULTRAVIST, because iopromide iodinated contrast products are typically off primary invention protection long ago, while present-day brand pricing is driven by procurement and supply reliability rather than IP exclusivity.
  • Sales elasticity tracks procedure volumes more than innovation, with periodic procurement wins and supply constraints changing quarterly revenue more than demand growth.

Market dynamics that typically govern ULTRAVIST-style iodinated contrast media:

  • Hospital purchasing consolidation into IDN formularies and tender contracts.
  • Switching costs are low relative to the class because products are therapeutically substitutable for most indications and dosing regimens.
  • Adverse-event and safety record matter for preferred formulary status, with insurers and providers tightening utilization management for CT and contrast-enhanced imaging.
  • Inventory and supply chain reliability affect short-term availability and can swing sales between quarters.

What drives ULTRAVIST (iopromide) demand in diagnostic imaging markets?

Direct demand driver: the volume of imaging procedures that use iodinated contrast media, primarily CT, angiography, and contrast-enhanced radiology protocols.

Imaging procedure volume and payer mix

  • Utilization is correlated to CT share of all radiology studies, which has been growing in many markets over the last decade.
  • Payer reimbursement constraints influence utilization but generally do not eliminate contrast use for medically necessary studies.
  • Emergency and inpatient imaging often sustains contrast demand even during elective-care slowdowns, though cash-flow tightening can delay non-urgent scans.

Clinical protocol standardization and formulary controls

  • Hospitals standardize protocols by:
    • Preferred concentration options (e.g., 300 mgI/mL, 370 mgI/mL class products)
    • Injection and patient preparation workflows
    • Product handling requirements (package format and volume)
  • Once a hospital standardizes, switching to an alternative is usually triggered by:
    • Contract expiration
    • Price improvements
    • Supply disruptions
    • Quality/USP or sterility incident outcomes

Safety, tolerability, and utilization management

Iodinated contrast purchasing decisions reflect:

  • Rates of adverse reactions and comfort with premedication practices
  • Compatibility with injection systems and power injectors
  • Evidence used by radiology and nephrology committees for contrast-associated risk mitigation

How do pricing and contracting dynamics shape ULTRAVIST (pharmacy bulk) financial performance?

Pricing model in practice: iodinated contrast is a procurement-driven product with negotiated discounts and tender-driven pricing rather than brand-patent value retention.

Hospital tendering and distributor leverage

  • “Pharmacy bulk” typically implies distribution in larger units to channel partners or institutional buyers.
  • Pricing pressure comes from:
    • Multi-bid tender awards
    • Greater use of secondary suppliers
    • Distributor margin optimization through bundled contracts (multiple imaging SKUs)

Price erosion pattern for mature contrast categories

For mature iodinated contrast categories, financial trajectories commonly show:

  • Early period: stable pricing under preferred supplier status
  • Mid period: recurring discounts as multi-source bids increase
  • Later period: margin compression with occasional swings from contract renegotiations or supply availability

Currency and tender timing

  • International operations and cross-border procurement can cause:
    • FX-driven volatility in revenue and reported margins
    • Timing mismatch between contract award and shipment realization

When does ULTRAVIST (iopromide) lose exclusivity and how does that impact revenue?

Because ULTRAVIST is iopromide, a mature iodinated contrast agent, the exclusivity profile is best evaluated as a category status rather than a single “ULTRAVIST pharmacy bulk” revenue line.

Patent and exclusivity framework relevant to contrast media

U.S. exclusivity and generic entry dynamics generally fall into:

  • Expired compositions and manufacturing patents (typical for mature active ingredients)
  • Remaining protection tied to:
    • Specific formulation/packaging claims
    • Process claims
    • Method-of-use (less common for contrast agents compared with chronic therapies)
  • FDA regulatory exclusivity is usually not the dominant revenue lever for established contrast media versus procurement

Net effect on financial trajectory

  • If composition protections are long expired, loss of exclusivity would have already occurred for most iopromide lines.
  • Current revenue variation is therefore driven more by:
    • Contract awards
    • Multi-source competition
    • Supply chain execution
    • Distributor allocation behavior

What patent estate protects ULTRAVIST (iopromide) products and how strong is it today?

A direct, claim-by-claim patent estate mapping requires a specific, FDA-linked ULTRAVIST product identity (NDA/ANDA/BLA labeling) and corresponding Orange Book listings, plus jurisdictional litigation records. The request is to cover ULTRAVIST “pharmacy bulk,” which is a distribution descriptor and does not uniquely identify an FDA product listing in a way that can be reliably tied to enforceable patent numbers and expiration dates.

Market-strength conclusion (actionable for business planning):

  • Treat ULTRAVIST as functionally non-exclusivity-driven for new entrant timing.
  • Competitive planning should assume multi-source substitution is available in most markets, with margin risk coming from procurement rather than patent cliffs.

What generic entry risks exist for ULTRAVIST (iopromide) and what would a launch scenario look like?

Launch mechanics in mature contrast categories

Generic or alternative entrants for iodinated contrast media typically launch via:

  • 505(j)-type pathways when allowed (regulatory route depends on product-specific authorization)
  • Contract manufacturing and packaging replication for institutional packs
  • Channel strategy focused on distributor access and tender readiness

Business impact playbook (typical)

A credible entrant’s financial impact plan includes:

  • Underbidding the incumbent in tenders for institutional accounts
  • Offering multiple concentrations and pack sizes to meet protocol standardization
  • Leveraging supply capacity to win during incumbent allocation constraints
  • Using clinical committee materials to support formulary acceptance

Revenue downside magnitude (directional)

In mature contrast markets, new multi-source entry typically triggers:

  • Immediate unit price erosion
  • Gradual share shift as hospitals renegotiate at contract renewal dates
  • Sustained margin pressure as the incumbent must match tender pricing

Which companies compete with ULTRAVIST (iopromide) across iodinated contrast media supply chains?

Competition is typically structured around:

  • Multi-national contrast suppliers
  • Institutional pack distributors
  • Tender-winning bidders in each geography

Commercial reality: buyers often evaluate at the level of “iodinated contrast for CT with preferred concentration options,” then award by:

  • Total landed cost
  • Contract terms
  • Availability and lead times
  • Device compatibility (power injectors and workflow)

Because the request is constrained to ULTRAVIST “pharmacy bulk,” a defensible, company-by-company competitive lineup requires mapping the specific product strengths, concentrations, and pack sizes to current tender catalogs by geography. That mapping cannot be completed from the provided prompt alone.


How does ULTRAVIST (iopromide) compare with other iodinated contrast agents in market position and switching dynamics?

Switching dynamics

  • Switching is typically easier between iodinated contrast brands than between therapeutically distinct drug classes.
  • Hospitals tend to standardize on one or two suppliers, but there is no durable “brand lock-in” absent contractual protection or unique clinical protocol advantages.

Competitive axes

  • Price per mL or per procedure set
  • Concentration availability and compatibility with injection protocols
  • Distribution reliability for emergency and high-utilization sites
  • Safety and tolerability perceptions used in committee deliberations

What is the Orange Book status of ULTRAVIST (iopromide) and what does it imply for litigation risk?

A definitive Orange Book status evaluation requires a product-specific NDA identifier and corresponding listed patents and exclusivities. “Pharmacy bulk” is not a substitute for an FDA product listing key.

Practical litigation-risk framing for businesses:

  • Mature contrast media generally see less high-stakes U.S. paragraph IV litigation compared with blockbuster small molecules and biologics.
  • The commercial risk is more likely tender and multi-source substitution than patent-based exclusivity blocking.

Which regulatory milestones and FDA statuses affect ULTRAVIST’s commercial trajectory?

For mature iodinated contrast products, regulatory events affecting commercialization are usually:

  • Manufacturing site changes and inspections
  • Label updates for safety communications
  • Packaging or concentration changes
  • Distributor and supply chain approvals

Financial translation: regulatory delays and supply disruptions can cause temporary revenue dips and allocation-driven substitution, but they are typically not structural long-term revenue determinants.


What settlement or Paragraph IV outcomes would matter for ULTRAVIST’s market share?

For ULTRAVIST (iopromide), structural market share shifts in practice typically follow:

  • Tender cycles and multi-source bids
  • Distributor allocations and contracting
  • Supply continuity

Paragraph IV settlements are less likely to be the dominant mechanism unless a specific product has active patent listings that support generic bottlenecking. No product-specific patent listing can be asserted from the prompt.


Geographic market dynamics: how do reimbursement and tender systems change ULTRAVIST sales?

U.S.

  • Competitive procurement is driven by GPO contracts, IDN purchasing, and hospital formulary decisions.
  • Tender renewals create recurring sales swings.

EU and other markets

  • More frequent multi-supplier procurement can occur via national tenders or hospital group buying.
  • Local regulatory and pricing controls can drive cross-border sourcing.

Middle-income and emerging markets

  • Supply continuity and local distribution capacity dominate.
  • Price sensitivity is high, with substitution more frequent.

Financial trajectory model for ULTRAVIST (iopromide pharmacy bulk): what metrics indicate momentum or deterioration?

Use these observable leading indicators:

  • Tender award frequency for your institutional customers
  • Bid competitiveness vs peer contrast suppliers at renewal windows
  • Inventory turns and time-to-ship metrics (allocation signals)
  • Net price trend (gross-to-net compression)
  • Market share by concentration/pack size rather than by overall brand name alone

Directionally expected financial path in mature contrast categories:

  • Revenue: modest growth or flat with procedural volume
  • Margin: gradual compression with periodic step-down after major contract renegotiations or multi-source entry

Key Takeaways

  • ULTRAVIST (iopromide) operates as a mature, procurement-driven iodinated contrast media product; financial trajectory is dominated by tendering, contracting, and multi-source substitution rather than patent cliffs.
  • For ULTRAVIST “pharmacy bulk,” public financial attribution is not reliably tied to a unique branded revenue line; treat performance as category economics: stable volume exposure with recurring pricing pressure.
  • Competitive risk is primarily contract and supply execution, not high-stakes paragraph IV litigation.
  • Business planning should focus on bid strategy, pack/concentration coverage, and supply reliability to defend unit share and limit net price erosion.

FAQs

  1. Why do iodinated contrast media brands lose net price even without major FDA safety events?
    Tender cycles and multi-source contracting drive gross-to-net compression independent of safety communications.

  2. What concentration or pack-size choices matter most for hospital formulary acceptance in iodinated contrast?
    Availability of preferred concentrations and injection workflows (including power injector compatibility) usually determines adoption during protocol standardization.

  3. How does supply interruption typically affect market share for contrast media suppliers?
    Allocation or backorders trigger temporary substitution; once contracts and protocols adjust at renewal, the incumbent can lose share beyond the resolution date.

  4. Do hospitals switch iodinated contrast suppliers based on patent litigation?
    Switching is usually driven by procurement outcomes and landed cost at renewal rather than patent-driven bottlenecks in mature active ingredients.

  5. What are the best financial leading indicators to track for ULTRAVIST-like contrast products?
    Net price trend, tender award cadence, time-to-ship/inventory availability, and share by concentration/pack format are the most predictive.


References (APA)

  1. No citable sources were provided in the prompt, and the request does not include FDA product identifiers (NDA/ANDA) or patent/public litigation records required for citation-grade analysis.

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