Last Updated: May 10, 2026

OMNIPAQUE 9 Drug Patent Profile


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When do Omnipaque 9 patents expire, and what generic alternatives are available?

Omnipaque 9 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 9 is iohexol. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the iohexol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Omnipaque 9

A generic version of OMNIPAQUE 9 was approved as iohexol by AMNEAL on November 13th, 2025.

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Recent Clinical Trials for OMNIPAQUE 9

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SponsorPhase
University of California, San DiegoPHASE2
Breakthrough T1DPHASE2
Fédération des médecins résidents du QuébecPhase 4

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Pharmacology for OMNIPAQUE 9

US Patents and Regulatory Information for OMNIPAQUE 9

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ge Healthcare OMNIPAQUE 9 iohexol SOLUTION;ORAL 018956-008 Apr 17, 2018 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

International Patents for OMNIPAQUE 9

See the table below for patents covering OMNIPAQUE 9 around the world.

Country Patent Number Title Estimated Expiration
Netherlands 7706385 ⤷  Start Trial
France 2435253 ⤷  Start Trial
Japan S5147702 ⤷  Start Trial
Netherlands 153083 ⤷  Start Trial
Japan S5531068 MANUFACTURE OF X RAY CONTRAST AGENT INJECTABLE STERILIZED SOLUTION ⤷  Start Trial
Spain 8200082 ⤷  Start Trial
Portugal 69869 ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

OMNIPAQUE 9 Market Analysis and Financial Projection

Last updated: April 24, 2026

OMNIPAQUE 9: Market Dynamics and Financial Trajectory

Omnipaque 9 (iohexol) is an iodinated contrast media product used for X-ray based imaging. “Omnipaque 9” aligns with a high-concentration iohexol formulation (300 mg I/mL class; some markets label “9” in local shorthand for 350 mg I/mL equivalents). Public financial reporting for this specific branded SKU is generally not disclosed separately from the broader Omnipaque portfolio and the parent company’s imaging business lines. Under observable market structure, Omnipaque pricing and revenue growth track (1) imaging utilization, (2) competitive entry by other iodinated contrast brands and generics, (3) payer contracting and hospital group tenders, and (4) regulatory or supply events that affect inventory availability.

How does the contrast media market set Omnipaque 9 pricing power?

Omnipaque 9 sits in a mature, supply-driven market where products compete primarily on formulary position, pack size, and contract price rather than on clinical differentiation alone. The market dynamics that govern pricing power are:

  1. Hospital contracting dominates net price

    • Imaging is purchased through hospital group tenders and GPO-style contracting.
    • Net price compression is common as buyers consolidate suppliers for high-volume contrast media use.
  2. Generic and authorized-duplicate pressure is structural

    • Iodinated contrast products are formulation-specific but often face competitive substitutes that can bid through hospital contracts.
    • Even where clinical switching is constrained, procurement processes can still drive down reimbursement-relevant unit costs.
  3. Utilization-linked demand

    • Demand scales with volume of CT, interventional radiology, and diagnostic imaging encounters.
    • Growth is driven by procedure volumes more than by incremental penetration.
  4. Portfolio-level cross-shopping

    • Hospitals often buy multiple concentrations (dose tailoring) from the same brand.
    • If a competitor undercuts one concentration, it can spill over to other strengths during renewal cycles.
  5. Supply continuity is a pricing lever

    • Shortages raise unit prices temporarily and can shift formulary access.
    • Conversely, restored capacity typically returns the market to contract-driven pricing.

What is the competitive landscape for an iohexol high-concentration branded product?

Omnipaque’s competitive set is other iodinated contrast brands and their generics/authorized duplicates, segmented by strength and regulatory approval in each geography. The competitive decision at the hospital level usually reduces to:

  • Acquisition price under contract
  • Availability and lot release reliability
  • Per-patient dosing convenience
  • Cold-chain or handling requirements (often not differentiators for most iodinated contrast formats)
  • Therapeutic switching protocols managed by radiology and pharmacy committees

Iohexol competes in the same diagnostic workflow as non-ionic, iodinated contrast alternatives (other chemical entities and equivalent strength presentations). The high-concentration segment is particularly tender-driven because it is used at scale in CT workflows, where switching one strength can affect total procurement spend.

What demand drivers likely shape the sales trajectory for Omnipaque 9?

The trajectory of Omnipaque 9 revenue is expected to follow four primary demand signals:

  • CT utilization trend
    • CT growth increases contrast media volumes because iodinated agents are widely used for contrast-enhanced imaging.
  • Interventional radiology growth
    • Expansion in minimally invasive procedures increases contrast consumption.
  • Aging demographics
    • In many markets, older patient volumes increase the share of imaging needs.
  • Hospital capex cycles and throughput
    • New scanner installs and faster throughput increase contrast usage per hospital.

These drivers typically support long-run baseline growth but do not prevent near-term revenue variability created by contracting and competitive bidding cycles.

How does formulary placement translate into financial outcomes?

For Omnipaque 9, formulary inclusion drives revenue more than brand awareness. The value chain looks like:

  • Radiology and pharmacy committees set preferred agents
  • Procurement executes contract pricing
  • Clinician choice is influenced by hospital policy, clinical protocols, and inventory access
  • Switching happens during contract renegotiations or when supply issues occur

In mature contrast markets, formulary durability is a major determinant of revenue stability. Where Omnipaque holds “preferred” status, revenue is less volatile. Where it loses bidding, volumes shift quickly to alternative brands or generics for the contracted strengths.

What financial trajectory pattern is typical for mature contrast brands?

A mature contrast brand’s revenue typically shows:

  • Mid-single-digit to low-single-digit unit growth tied to procedure volumes.
  • Flat to declining net pricing as tender pressure and competitive supply expand.
  • Profit margin sensitivity to procurement discounting and freight/inventory costs.
  • Earnings volatility during supply disruptions or normalization after shortages.

For Omnipaque specifically, published corporate reporting is generally aggregated across the imaging portfolio and does not isolate “Omnipaque 9” revenue. Still, the market mechanics imply a trajectory where top-line growth is mostly volume-led, while price declines cap margin expansion.

What product and regulatory factors constrain or enable Omnipaque 9 growth?

Omnipaque is a non-ionic iodinated contrast agent. Product availability, safety profile acceptance, and manufacturing continuity govern sustained prescribing. Key constraints and enablers include:

  • Dose tolerance and clinical familiarity
    • Stable clinical acceptance supports continued prescribing once a hospital buys in.
  • Safety and risk management
    • Adverse event scrutiny does not typically eliminate established brands, but it shapes protocol-based use and reinforces formulary governance.
  • Regulatory maintenance and labeling
    • Ongoing label compliance supports uninterrupted market access.
  • Batch availability and supply continuity
    • Contrast media is sensitive to manufacturing throughput; shortages can temporarily lift pricing but usually lead to normalization when capacity returns.

How have major policy and coverage dynamics historically affected contrast utilization?

Reimbursement and payer policy can affect utilization patterns indirectly:

  • Bundled payments and radiology reimbursement changes
    • Alter incentives around imaging frequency and site of service.
  • Prior authorization policies
    • Can slow imaging growth in some settings, changing monthly volumes.
  • Hospital budgeting
    • Drives procurement focus on unit cost and contract pricing.

These forces usually change utilization pace rather than eliminate demand, which keeps Omnipaque 9 tied to imaging procedure cycles.

Where does Omnipaque 9 sit in a portfolio valuation view?

From an investor or R&D funding perspective, Omnipaque 9 is best viewed as:

  • A high-throughput, mature asset where revenue growth depends on maintaining contract access.
  • A cash flow generator whose risk is mainly commercial (tender losses, pricing compression) and operational (supply continuity).
  • A product where incremental R&D is less likely to create step-function differentiation relative to chemical class substitutes unless a new formulation or delivery system meaningfully improves economics or workflow.

What near-term market signals matter most for tracking the financial trajectory?

To forecast the path of Omnipaque 9 revenue and margin, the most decision-useful signals are:

  1. Contract renewal outcomes at large hospital groups
    • A preferred-to-alternate switch can immediately reallocate volumes for high-volume strengths.
  2. Evidence of pricing stabilization or renewed discounting
    • Watch for signs that tender competition is easing or intensifying.
  3. Supply stability
    • Manufacturing continuity influences stock availability and pharmacy substitution rates.
  4. Procedure volume indicators
    • CT scan counts and imaging growth by region.
  5. Regional reimbursement changes
    • Payer edits that affect authorization patterns and site-of-service mix.

How does demand elasticity differ between branded strengths and generic equivalents?

Branded high-concentration agents often face greater elasticity at the contract level than at the clinician level:

  • When hospitals have approved protocols for substitution, unit cost becomes the dominant factor.
  • When safety or workflow constraints require specific handling or dosing equivalency, substitution rates can be moderated.
  • Across tender cycles, switching can be rapid if the procurement economics favor alternatives.

This results in financial trajectories that typically show stable baseline demand but volatile net pricing.

What is the likely cost and margin structure pressure profile for Omnipaque 9?

Net margin drivers in contrast media typically include:

  • Manufacturing cost stability
    • Scale economies matter because volumes are large.
  • Freight and inventory carrying
    • Availability shocks can increase costs.
  • Contract discounts
    • Tiered pricing and rebates compress net realization.
  • Customer mix
    • Larger hospital systems can negotiate stronger pricing.

Given market maturity, the largest financial swing factor is net price under contract rather than unit manufacturing cost.


Key Takeaways

  • Omnipaque 9 revenue trajectory is primarily driven by imaging procedure volumes and hospital contract/formulary outcomes, with net pricing compression as the dominant constraint.
  • Market structure is tender-driven: preferred placement produces relative stability, while contract losses can reallocate high-volume units quickly.
  • Financial outcomes are likely volume-led and price-capped, with margin sensitivity to discounting, rebates, and supply continuity.
  • Near-term trackable signals for forecasting are contract renewal results, net price direction, supply stability, and CT/interventional procedure volume trends.

FAQs

1) What does “Omnipaque 9” correspond to commercially?

It refers to an Omnipaque high-concentration iohexol presentation used for contrast-enhanced imaging, typically aligned with high-iodine-strength labeling conventions in local or shorthand market usage.

2) Is Omnipaque 9 differentiated clinically?

Differentiation is usually limited once competing non-ionic iodinated contrast agents are considered clinically equivalent in standard practice; hospital purchasing often prioritizes pricing, availability, and formulary protocols.

3) What causes the biggest revenue swings in mature contrast markets?

Hospital contract outcomes and net price changes from tenders, plus temporary inventory or supply disruptions.

4) Does contrast media demand grow faster than imaging procedures?

Usually demand tracks imaging procedure growth; contrast media usage per scan is relatively protocol-dependent but the overall market scales with CT and interventional volumes.

5) What are the main financial risks for an Omnipaque 9-like asset?

Net price compression from competitive bidding, formulary loss during renewals, and operational supply constraints.


References

[1] EMA. Omnipaque (iohexol) summary of product characteristics. European Medicines Agency. https://www.ema.europa.eu/
[2] FDA. Omnipaque (iohexol) prescribing information. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/
[3] WHO. Medical devices and diagnostics: iodinated contrast media and imaging utilization context. World Health Organization. https://www.who.int/

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