Last Updated: September 24, 2026

VISIPAQUE 270 Drug Patent Profile


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Which patents cover Visipaque 270, and when can generic versions of Visipaque 270 launch?

Visipaque 270 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in VISIPAQUE 270 is iodixanol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the iodixanol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Visipaque 270

A generic version of VISIPAQUE 270 was approved as iodixanol by HENGRUI PHARMA on May 19th, 2022.

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Recent Clinical Trials for VISIPAQUE 270

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

SponsorPhase
Institute of Liver and Biliary Sciences, IndiaN/A
University of WashingtonPhase 1
GuerbetPhase 1

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Pharmacology for VISIPAQUE 270

US Patents and Regulatory Information for VISIPAQUE 270

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351-001 Mar 22, 1996 AP RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020808-001 Aug 29, 1997 DISCN No 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

Expired US Patents for VISIPAQUE 270

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020351-001 Mar 22, 1996 4,278,654 ⤷  Start Trial
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020808-001 Aug 29, 1997 5,349,085 ⤷  Start Trial
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020808-001 Aug 29, 1997 5,366,722 ⤷  Start Trial
Ge Healthcare VISIPAQUE 270 iodixanol INJECTABLE;INJECTION 020808-001 Aug 29, 1997 4,396,597 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for VISIPAQUE 270

See the table below for patents covering VISIPAQUE 270 around the world.

Country Patent Number Title Estimated Expiration
Argentina 222337 PROCEDIMIENTO PARA PREPARAR UNA SOLUCION ESTERIL INYECTABLE FISIOLOGICAMENTE ACEPTABLE DE UN AGENTE DE CONTRASTE DE RAYOS X ⤷  Start Trial
Austria 371998 ⤷  Start Trial
Austria A464479 ⤷  Start Trial
Australia 4861579 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VISIPAQUE 270

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0108638 SPC/GB93/150 United Kingdom ⤷  Start Trial SPC/GB93/150, 20031107, EXPIRES: 20080330
0108638 97C0101 Belgium ⤷  Start Trial PRODUCT NAME: IODIXANOL; NAT. REGISTRATION NO/DATE: 914 IS 204 F 12 19970325; FIRST REGISTRATION: SE 11758 19930205
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Last updated: July 23, 2026

VISIPAQUE 270 market dynamics and financial trajectory (iodixanol 270 mgI/mL)

VISIPAQUE 270 (iodixanol 270 mgI/mL) is a low-volume, hospital-and-imaging-driven iodinated contrast product whose pricing and unit demand are shaped more by hospital formulary cycles, diagnostic procedure mix (CT/angiography vs. X-ray/IR), and competitor tendering than by new clinical competition. Financial trajectory is characterized by: (1) U.S. market stability for legacy iodinated contrast brands supported by soft generics adoption barriers, (2) mid-single-digit annual swings in units driven by procedure volumes and contract pricing, and (3) margin compression when biosimilar-like substitution is not available but price concessions occur via group purchasing and distributor programs.

Core market drivers

  • Procedure volume and case mix in radiology and interventional suites (CT, cardiac/vascular imaging, peripheral angiography, interventional radiology).
  • Contract pricing and formulary positioning in IDNs and GPOs.
  • Substitution dynamics among iodinated contrast classes and brand portfolios (osmolarity and tolerability perceptions, device compatibility, and nursing workflow).
  • Regulatory and supply chain continuity (contrast media manufacturers face periodic capacity and raw materials constraints).
  • Channel mix between hospital procurement, outpatient centers, and specialty distribution.

What is VISIPAQUE 270 and how is it used in imaging markets?

VISIPAQUE 270 is an iodinated contrast medium for diagnostic imaging, used to enhance vascular and organ visualization in CT and other radiology procedures. The commercial market behaves like a hospital consumable: repeat usage, high purchasing scrutiny, and contract-based economics.

Where does VISIPAQUE 270 fit within iodinated contrast demand?

  • CT is the largest use case in iodinated contrast categories in the U.S., and competitive pressure often centers on brand-to-brand switching within iodinated contrast.
  • Hospitals frequently standardize on one to two contrast brands for protocol consistency, nursing practices, and stock management.
  • Interventional radiology and angiography maintain comparatively durable demand for specific contrast properties and clinical workflows.

How do concentration and dosing shape purchasing?

  • VISIPAQUE 270’s 270 mgI/mL strength is positioned for a subset of imaging protocols where dosing requirements and contrast-to-background balance are operational preferences.
  • Hospital formularies often track multiple concentrations (including 320 and other strengths depending on product line) and allocate by patient need, order sets, and contrast utilization protocols.

How does VISIPAQUE 270 market dynamics compare with other iodinated contrast brands?

Competition is mostly within the iodinated contrast segment, not across therapeutic classes. Market share shifts are driven by contract awards, switching friction (protocol training, supply continuity), and tender economics.

Key comparator dimensions

  • Osmolality and tolerability narratives used in purchasing committees.
  • Volume-based contracting and rebate structures.
  • Availability and packaging format (bottle sizes, vial/carton formats) affecting stocking and dosing draw practices.
  • Preferred supplier relationships with GPO-contract vendors and distributors.

What typically causes switching among iodinated contrast products?

  • IDN GPO renegotiation cycles and rebid windows.
  • Safety communications and label updates that impact clinical governance.
  • Supply disruptions that temporarily raise substitution acceptance.
  • Tender bids that price into a target acquisition cost per mL while meeting protocol criteria.

When does VISIPAQUE 270 face exclusivity and generic substitution risk?

VISIPAQUE 270 is the legacy iodixanol brand within the iodinated contrast space. For market dynamics, exclusivity risk is dominated by whether FDA-approved generic or “AB-rated” equivalents exist and whether hospitals treat substitution as clinically equivalent under their governance.

What matters for generic entry in contrast media?

  • Regulatory approval pathway for generic iodinated contrast solutions and interchangeability decisions in practice.
  • Hospital preference management: even if FDA allows AB substitution, many IDNs still require switching only through protocol committees.
  • Distribution and rebate mechanics that determine whether the “cheapest AB” wins the contract.

Financial implication: even when generics exist, branded incumbents can hold economics through negotiated rebates, device/workflow compatibility, and contract steering.


What patents protect VISIPAQUE 270 and how strong is the patent estate for iodixanol 270?

For an IP-driven view of market dynamics and financial trajectory, the relevant questions are whether additional formulation, method-of-use, manufacturing process, or packaging patents extend exclusivity beyond initial product approvals, and whether competitors have carved-out patent positions that constrain settlement or licensing outcomes.

Patent estate elements that typically matter for contrast media

  • Manufacturing process claims (sterility assurance, filtration, particle spec control).
  • Composition and formulation claims (stability, viscosity targets, excipient balance).
  • Concentration-specific patents and packaging formats.
  • Method-of-use claims (less common for contrast media; most protection is product and manufacturing rather than narrow indications).

Commercial relevance

  • If patent barriers are still active, they limit “authorized generic” or value-engineered entrants.
  • If patent barriers lapse or are weak, hospitals can push stronger AB substitution, accelerating unit share volatility and margin compression.

Result: VISIPAQUE 270’s financial trajectory is typically more sensitive to contract pricing than to headline patent expiry, unless a litigation or settlement drives a near-term generic entry.


What patent litigation affects VISIPAQUE 270 and related iodixanol products?

Iodinated contrast brands can be subject to patent challenges and settlement-driven entry timing. For market dynamics, the key is whether disputes have produced:

  • a delayed generic launch,
  • a “design-around” product,
  • or a stipulation allowing entry with defined restrictions.

How litigation timing impacts financial trajectory

  • Market share: typically shifts quickly if a lower-priced AB is authorized and contracted.
  • Pricing: branded incumbents often respond with rebate hikes, which can preserve units but reduce gross margin.
  • Supply: entrants with capacity constraints can delay full uptake even if approval occurs.

What is the Orange Book status of VISIPAQUE 270 (iodixanol 270)?

Orange Book listing and the presence or absence of patent blocks (drug substance, drug product, and method-of-use) determine:

  • whether FDA-approved generics can be submitted via Paragraph IV,
  • and whether the product is encumbered by active patents.

Why Orange Book completeness drives market expectations

  • Active patents increase the probability of Paragraph IV litigation.
  • Weak listing (few or expiring patents) increases expected substitution speed after approval.

How does FDA status and manufacturing compliance affect supply and revenue for VISIPAQUE 270?

Contrast media are sensitive to manufacturing quality systems and sterility assurance. FDA status affects supply continuity, which directly affects sales in hospital procurement.

Supply risks that move revenue

  • Batch release delays caused by quality investigations.
  • Manufacturing line downtime or raw material shortages.
  • Packaging configuration constraints (vial/bottle format discontinuations).

Financial mechanism

  • If shortages occur, incumbents can temporarily raise net pricing but lose volume where hospitals permanently switch.
  • If supply normalizes, units return but often at lower net prices if contracts adjusted.

What formulations and presentation formats of VISIPAQUE 270 influence purchasing?

Purchasers decide based on total acquisition cost per procedure and operational handling.

Presentation-driven variables

  • Bottle/vial size options enabling protocol-specific dosing.
  • Clinician workflow and draw time.
  • Compatibility with existing IV tubing and injection devices.

Implication for market dynamics

  • A product with fewer compatible formats can lose tenders even if clinical performance is similar.
  • Packaging availability can be decisive in rebid cycles.

What commercial trajectory has VISIPAQUE 270 shown in the U.S. and how do revenues typically evolve?

VISIPAQUE 270’s revenue trajectory generally tracks:

  • stable procedure volumes with modest declines or growth depending on imaging utilization,
  • periodic step-downs in net price as contracts reprice,
  • and limited share expansion due to entrenched hospital protocols.

Expected revenue shape in low-growth contrast categories

  • Near-term: incremental price compression through contracting rather than major unit collapse.
  • Mid-term: unit growth is often capped by institutional switching inertia and standardized sourcing.
  • Longer-term: potential for acceleration of substitution if AB competition gains contract dominance.

What factors drive VISIPAQUE 270 pricing, net revenue per mL, and gross margin?

Pricing in contrast media is dominated by net price after rebates and discounts.

Key levers

  • GPO and IDN contracting: net price resets at rebid points.
  • Distributor economics: tiered distributor pricing affects effective hospital acquisition cost.
  • Mix: shifts in concentration and total mL consumption across protocols change revenue per case.
  • Competitive spend: incumbents often rebalance rebates to maintain formulary positioning.

Margin impact

  • Contract-driven net price declines reduce gross margin unless compensated by manufacturing cost improvements and inventory management.

Which companies compete with VISIPAQUE 270 and what is the competitive strategy landscape?

Competition consists of iodixanol and other iodinated contrast agents marketed as alternatives for CT and vascular imaging. The strategic pattern is tender-led pricing and formulary inclusion rather than broad brand campaigns.

Competitive behavior common in this market

  • Volume commitments in exchange for rebate and shelf placement.
  • Supply assurances tied to long-term contracts.
  • Pharmacy and radiology education tied to conversion protocols.

What generic entry risks exist for VISIPAQUE 270 and how could they change market share?

Generic entry risk is real when:

  • Orange Book patents are limited or expiring,
  • Paragraph IV litigation ends in settlement allowing earlier entry,
  • and the contracting entity’s governance permits AB substitution.

How market share typically shifts if AB entry occurs

  • Immediate: contract switching in rebid windows; some hospitals switch even mid-cycle if supply pressure exists.
  • Gradual: protocol changes, prescriber behavior, and staff training slow uptake for 1 to 2 procurement cycles.
  • Durable: once standardized, hospitals are reluctant to reverse unless price differentials widen.

How does VISIPAQUE 270 compare with VISIPAQUE 320 and other iodixanol strengths commercially?

Strength-level performance is usually mix-driven rather than brand identity-driven.

Mix and protocol effects

  • Higher concentrations often capture procedures requiring lower injection volumes.
  • Lower concentrations like 270 may be preferred for selected protocols and patient considerations.
  • Hospitals often carry multiple strengths and allocate usage by protocol sets, meaning share gains can occur even if overall category volume is flat.

What settlement agreements and licensing deals could influence VISIPAQUE 270 market timing?

The financial impact comes from settlement terms that determine:

  • launch timing,
  • authorized generic availability,
  • and any negotiated market sharing or exclusivity carve-outs.

Commercial impact channels

  • Earlier-than-expected entry compresses net pricing quickly.
  • Delayed entry extends the incumbents’ ability to maintain contracts.
  • Authorized generic can reduce the expected pricing impact by narrowing the gap between brand and generic.

Key Takeaways

  • VISIPAQUE 270’s financial trajectory is primarily contract and procedure-volume driven, with pricing resets dominating over clinical differentiation.
  • Exclusivity and generic substitution risk are mediated by Orange Book patent blocks, Paragraph IV litigation patterns, and hospital governance on AB substitution.
  • Competitive dynamics in iodinated contrast media center on tendering, net price after rebates, supply continuity, and operational fit of product presentations.
  • Supply interruptions can create short-term pricing lift but often increase long-term switching risk when hospitals re-contract.

FAQs

1) How do group purchasing organization contracts change VISIPAQUE 270 net pricing?

GPO rebids reset net price through rebate and discount structures; the effective acquisition cost per mL can drop sharply even when list price remains stable.

2) Would a generic iodixanol launch automatically reduce VISIPAQUE 270 unit sales?

Not automatically; uptake typically follows procurement cycles and protocol governance even when FDA permits AB substitution.

3) What hospital factors most influence contrast brand selection for CT and angiography?

Formulary strategy, nursing workflow, dosing protocol alignment, device compatibility, and historical switching inertia.

4) What manufacturing or FDA quality events can materially affect VISIPAQUE 270 revenue?

Batch release delays, sterility-related investigations, and packaging configuration disruptions that constrain supply can reduce volume and trigger contract changes.

5) Does VISIPAQUE 270 track the broader iodinated contrast market or lead it?

It generally tracks category growth with lag due to established hospital protocols, though it can outperform or underperform based on strength mix and contract awards.


References

  1. FDA. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration.
  2. FDA. Drug Approval Reports and Labeling for iodixanol-containing products. U.S. Food and Drug Administration.
  3. U.S. Patent and Trademark Office. Patent assignment and bibliographic records for iodixanol-related filings. USPTO.

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