Last Updated: May 10, 2026

OMNIPAQUE 350 Drug Patent Profile


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Which patents cover Omnipaque 350, and when can generic versions of Omnipaque 350 launch?

Omnipaque 350 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in OMNIPAQUE 350 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 350

A generic version of OMNIPAQUE 350 was approved as iohexol by AMNEAL on November 13th, 2025.

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  • What is the 5 year forecast for OMNIPAQUE 350?
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  • What is Average Wholesale Price for OMNIPAQUE 350?
Recent Clinical Trials for OMNIPAQUE 350

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

SponsorPhase
Breakthrough T1DPHASE2
University of California, San DiegoPHASE2
Centre for Interdisciplinary Research in Rehabilitation of Greater MontrealPhase 4

See all OMNIPAQUE 350 clinical trials

Pharmacology for OMNIPAQUE 350

US Patents and Regulatory Information for OMNIPAQUE 350

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 350 iohexol SOLUTION;INJECTION, ORAL 018956-004 Dec 26, 1985 RX Yes Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Ge Healthcare OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 020608-003 Oct 24, 1995 RX 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 OMNIPAQUE 350

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Ge Healthcare OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 018956-004 Dec 26, 1985 4,396,597 ⤷  Start Trial
Ge Healthcare OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 018956-004 Dec 26, 1985 4,021,481 ⤷  Start Trial
Ge Healthcare OMNIPAQUE 350 iohexol SOLUTION;INJECTION, ORAL 018956-004 Dec 26, 1985 4,250,113 ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for OMNIPAQUE 350

See the table below for patents covering OMNIPAQUE 350 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
>Country >Patent Number >Title >Estimated Expiration

OMNIPAQUE 350: Market Dynamics and Financial Trajectory

Last updated: April 25, 2026

What is OMNIPAQUE 350 in the market, and how is it positioned?

OMNIPAQUE 350 is a non-ionic, iodinated contrast medium used for radiographic imaging (CT and related angiography/urography indications). The active ingredient is iohexol. In this market, OMNIPAQUE competes primarily on (1) radiographic performance at equivalent iodine delivery, (2) supply continuity and shelf-life, (3) contract pricing with hospital systems and distributors, and (4) brand and label breadth versus lower-cost generic iohexol products.

Core market dynamic: iohexol contrast products trade like “commodity-like branded injectables.” Brand longevity and hospital formulary placement matter, but pricing pressure from licensed/approved alternatives is persistent. Buyers typically base contracting decisions on total cost of care, dosing flexibility, and procurement terms rather than clinical differentiation alone.

How does competition shape pricing and volume for OMNIPAQUE 350?

The iohexol contrast segment faces a standard set of economic forces:

  • Multiple supply sources: Any licensed iohexol manufacturer with matching concentration and presentation can bid into hospital tenders.
  • Class equivalence: At the point of use, iohexol products are close substitutes in clinicians’ workflows, which constrains sustained pricing premiums.
  • Contracting and group purchasing: Large hospital systems and distributors use multi-year price locks, rebid cycles, and rebate structures.
  • Tender-driven volume swings: When a system switches preferred suppliers, volume shifts quickly due to standard contrast workflows.

Implication for OMNIPAQUE 350: market share tends to be “sticky” once a formulary is set, but it can erode during rebids, particularly where competitors undercut list price and offer higher channel incentives.

What regulatory and access factors affect the product’s sales trajectory?

Contrast media procurement is tightly linked to national and regional reimbursement frameworks and hospital purchasing requirements. OMNIPAQUE 350’s access depends on:

  • Approval status in each territory (marketing authorizations and maintained quality).
  • Label alignment with imaging protocols used by target hospital networks.
  • Supply reliability and compliance with manufacturing quality expectations (FDA and equivalent regimes in other jurisdictions).
  • Packaging and presentation match to standard CT kits and dosing habits.

Implication: Even without major clinical differentiation, uninterrupted supply and “fit” to contracting specifications are decisive for annual unit stability.

How do procurement and tender economics influence revenue realization?

Revenue realization for branded contrast products is rarely “list price to patient.” It typically depends on:

  • Wholesale and distributor markups versus direct contracting.
  • Hospital group purchasing rebates that lower effective net price.
  • Volume-tier discounts contingent on quarterly usage.

Typical outcome in this category:

  • Net price compresses when competitor bids clear tenders.
  • Unit volume can stay stable (or decline modestly) even if list prices fall, because usage remains protocol-driven.
  • The revenue line is therefore sensitive to contracting outcomes more than to end-user demand growth.

How likely is OMNIPAQUE 350’s pricing path to trend over time?

Across iodinated contrast categories, the normal financial trajectory under competition is:

  • Early stability after brand re-anchoring on formularies.
  • Downward net price pressure after new entrants or aggressive bidding cycles.
  • Heightened volatility around large system rebids and distributor re-assignments.

For OMNIPAQUE 350 specifically, as a long-established iohexol brand strength tends to be supported by institutional familiarity and logistics fit, which delays erosion. But the concentration (350 mg I/mL) is a standard benchmark, so price competition remains structurally likely.

What does the historical financial trajectory look like at a category level?

For pharmaceutical products that behave like contrast commodities, financial performance typically follows this pattern:

  1. Unit demand is relatively stable because CT and related imaging utilization grows gradually with healthcare capacity and practice patterns.
  2. Revenue growth can lag utilization when net prices fall faster than volumes rise.
  3. Margins compress when channel incentives increase or when pricing is reset to win tenders.

Implication for OMNIPAQUE 350: revenue trajectories in this segment are usually “utilization-plus-minus-price,” not “pure demand growth.”

What market indicators are most predictive for OMNIPAQUE 350?

Key indicators for the product’s forward financial trajectory are not clinical endpoints. They are procurement and utilization drivers:

  • CT procedure volumes in target hospital systems and geographies.
  • Hospital formulary decisions (preferred supplier status).
  • Distributor channel shifts and contract re-bids.
  • Tender participation density (how many equivalent iohexol bidders enter a given region).
  • Pricing actions by competing iohexol brands.

How does supply chain risk influence financial outcomes?

Contrast media are high-frequency hospital products with tight operational timing. Supply chain disruptions can drive short-cycle revenue spikes (from stock-constrained competitors) or losses (if the product is unavailable). For OMNIPAQUE 350, financial trajectory sensitivity increases when:

  • Manufacturers face raw material price volatility (iodine-related inputs).
  • Manufacturing line constraints reduce allocation during demand surges.
  • Competitors experience localized shortages that temporarily reallocate market share.

What are the main strategic levers OMNIPAQUE 350 can use in the market?

Within a commodity-like branded injectable space, differentiation often comes from commercial execution:

  • Formulary retention through hospital contracting and rebate optimization.
  • Supply reliability and forecast accuracy for stable delivery during bidding cycles.
  • Presentation and packaging choices that match institutional CT workflows.
  • Channel management to maintain distributor inventory turns and avoid stock-outs.

Can OMNIPAQUE 350 sustain premium pricing versus generics?

Premium pricing sustainability depends on two constraints:

  • Clinical equivalence: where equivalents are treated as interchangeable, premiums are limited by procurement economics.
  • Contract structure: rebates and rebates-in-disguise (bundling) narrow the gap between branded and competitor net prices.

In practice, the branded premium can persist when:

  • A hospital system uses OMNIPAQUE as a preferred product and is slow to switch.
  • Competitor products face supply inconsistencies.
  • Contract terms embed historical relationships.

It erodes when:

  • Aggressive rebids introduce materially lower net price offers.
  • Procurement teams enforce standardized alternatives across sites.

What does “market dynamics” imply for financial trajectory in investment terms?

For investors or corporate planning, the financial model for OMNIPAQUE 350 in the iohexol contrast space is best viewed as:

  • Stable baseline demand with contract-driven revenue variation.
  • Net price compression risk as competition and tender intensity rise.
  • Margin variability driven by channel incentives and rebate escalators.
  • Share movement primarily at formulary rebid moments, not through continuous month-to-month demand changes.

This makes OMNIPAQUE 350’s near-term trajectory more dependent on commercial execution than on product-level scientific events.

What is the current competitive reference point for iohexol at 350 mg I/mL?

The concentration 350 mg I/mL is a standard CT strength benchmark. That means OMNIPAQUE 350 competes against other iohexol 350 mg I/mL offerings that can be substituted in routine protocols, shifting competition to packaging availability, net contracting terms, and distribution execution.

Key Takeaways

  • OMNIPAQUE 350 is a branded iohexol contrast medium that competes in a structurally substitutable, tender-driven market.
  • Pricing is constrained by class equivalence and contract economics, which typically drive net price pressure under competition.
  • Revenue trajectory follows “utilization plus minus net price,” not a purely clinical differentiation curve.
  • Formulary and distributor contracting moments are the dominant drivers of revenue volatility and share shifts.
  • Supply reliability and presentation fit are commercially decisive for maintaining hospital placement and sustaining unit volumes.

FAQs

How does OMNIPAQUE 350 usually behave during hospital tender cycles?

Sales often track preferred-supplier status. When contracts are renewed, volume stays stable; when rebids shift preferred procurement to other iohexol sources, units can drop quickly while net price becomes a negotiation lever.

What drives net revenue more than wholesale list price?

Rebates, distributor terms, and hospital group purchasing agreements typically determine effective net price. Net revenue usually compresses as competitors bid lower.

Is CT utilization growth enough to offset pricing pressure?

Often partially. If net price declines faster than procedure growth, revenue can still lag. The offset depends on contract outcomes and how quickly pricing resets after rebids.

What operational factors can create short-term financial swings?

Stock-outs, allocation constraints, and localized supply interruptions by any manufacturer can reallocate usage temporarily, affecting short-cycle net sales.

What is the main commercial risk for OMNIPAQUE 350?

Loss of preferred supplier status in high-volume hospital networks due to lower-cost iohexol alternatives and aggressive rebate structures.


References

[1] U.S. Food and Drug Administration. Omnipaque (iohexol) Prescribing Information. FDA drug database. https://www.accessdata.fda.gov/

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