Last Updated: May 10, 2026

OMNIPAQUE 210 Drug Patent Profile


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Which patents cover Omnipaque 210, and what generic alternatives are available?

Omnipaque 210 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 210 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 210

A generic version of OMNIPAQUE 210 was approved as iohexol by AMNEAL on November 13th, 2025.

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Recent Clinical Trials for OMNIPAQUE 210

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

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Pharmacology for OMNIPAQUE 210

US Patents and Regulatory Information for OMNIPAQUE 210

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 210 iohexol INJECTABLE;INJECTION 018956-006 Jun 30, 1989 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

International Patents for OMNIPAQUE 210

See the table below for patents covering OMNIPAQUE 210 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
>Country >Patent Number >Title >Estimated Expiration

Omnipaque 210 (iohexol injection): Market dynamics and financial trajectory

Last updated: April 24, 2026

Omnipaque 210 (iohexol) is an iodinated X-ray contrast media brand with pricing and volume patterns driven by procedure mix (CT angiography and other CT studies), channel access to hospital formularies, and supply stability across global manufacturing networks. Financial trajectory is shaped less by patent-driven exclusivity and more by (1) generic entry risk across geographies, (2) tender dynamics in hospital systems, and (3) utilization headwinds that follow reimbursement pressure and radiology throughput constraints.

Where does Omnipaque 210 sit in the contrast media market?

Omnipaque is the branded iohexol franchise of GE Healthcare (now part of GE HealthCare). Iohexol is used as a nonionic, low-osmolality iodinated contrast agent for X-ray imaging and is marketed in multiple concentrations and pack formats, including 210 mg I/mL. Omnipaque 210 is typically positioned for CT and related imaging workflows where prescribers select based on viscosity/handling characteristics and institutional purchasing.

Market demand drivers

  • CT growth and angiography intensity: Higher utilization of CT and CT angiography supports sustained contrast consumption growth.
  • Hospital procurement behavior: Most large-volume purchases happen through tenders and formulary decisions, which compress net prices after generic or competing brand wins.
  • Switching friction: Clinical familiarity and protocol lock-in delay switching when a hospital changes supplier, but tender cycles still drive price resets.

Competitive set

Omnipaque 210 competes with:

  • Other iodinated nonionic contrast brands (same class, different formulations and packaging).
  • Generic iohexol products once authorized and stocked in-country.
  • Alternate agents from rival low-osmolality iodinated lines depending on regional formularies.

How do supply, tendering, and reimbursement shape unit economics?

Tender and formulary effects (net price compression)

Hospital and distributor contracts determine net revenue far more than list pricing. In iodinated contrast, the post-authorization commercialization pattern typically follows this order:

  • Brand price resilience while formulary access and preferred-use protocols remain in place.
  • Step-down pressure when generics and alternate suppliers win tender rounds or obtain equivalent listing.

For Omnipaque 210, that means financial outcomes track:

  1. Contract award cycles at IDNs (integrated delivery networks) and major hospital groups.
  2. Regional distribution coverage and inventory availability (supply continuity reduces stockout risk premiums).
  3. Pack-level economics (single-dose vs multi-pack) and whether conversion factors align with protocol volumes.

Reimbursement and imaging utilization

Contrast spend is a small fraction of imaging episode cost but still subject to procurement scrutiny:

  • When reimbursement per scan tightens, hospitals resist price increases and prefer lower net-cost options.
  • During budget cycles, administrators treat contrast as a controllable consumable.

Safety labeling and switching

Iohexol’s safety profile is well understood. Switching is usually less constrained by clinical safety concerns and more constrained by:

  • Institutional conversion protocols (standard prep, administration devices, and emergency pathways).
  • Radiology practice preferences that affect time-to-switch after tendering.

What is the likely financial trajectory for Omnipaque 210?

Core trajectory pattern in iodinated contrast

Across markets, branded iodinated contrast products typically show:

  • Early commercialization strength with stable net pricing where exclusive access persists.
  • Mid-life stagnation as competition increases and tendering compresses net prices.
  • Volume resilience if CT utilization grows enough to offset price erosion, but margin tends to normalize downward over time.

For Omnipaque 210 specifically, the trajectory is consistent with a branded, mature product whose economics track procurement outcomes and procedure mix more than scientific differentiation.

Offsetting factors that can stabilize revenue

Even with price pressure, revenue can remain durable if:

  • CT throughput keeps rising in supported regions.
  • Hospital systems keep standardized protocols that keep Omnipaque in use.
  • GE HealthCare maintains supply quality and distribution service levels that avoid losing preferred status.

Downside factors

  • Generic substitution: As iohexol generics gain traction, net price declines usually accelerate.
  • Large-contract re-tenders: If Omnipaque loses a preferred contract, volumes can drop quickly and may not fully recover.
  • Regulatory and manufacturing disruptions: Any supply constraint can cause allocation or loss of shelf position.

How does Omnipaque 210 map to GE HealthCare’s financial exposure?

Omnipaque is part of GE HealthCare’s Imaging equipment plus pharmaceuticals/contrast segment ecosystem. GE HealthCare reports revenues across multiple lines, with contrast media included in broader imaging-related offerings. While specific Omnipaque 210 segment reporting is not typically broken out at product-concentration level in public reporting, the financial impact follows:

  • General correlation to imaging procedure volumes across installed base.
  • Exposure to procurement and tender pressure in contrast media categories.
  • Foreign exchange effects because contrast is traded globally and sourced/manufactured across regions.

What do regulatory and labeling details imply for commercialization?

Omnipaque 210 is regulated as an iodinated contrast agent for intravascular and other imaging uses depending on local labeling. It is marketed with a standardized concentration target (210 mg I/mL) that supports predictable dosing volumes in CT workflows.

Key commercialization implications:

  • Protocol standardization: Concentration-specific workflows support stable use patterns even when mix changes between CT and other imaging modalities.
  • Switchability: As long as products meet bioequivalence standards and packaging supports dosing, switch barriers are primarily administrative and contractual.

Regulatory labeling anchors for iohexol products like Omnipaque include patient warnings and administration instructions typical for iodinated contrast agents. Prescribing behavior generally follows those instructions and institutional protocol.

Where is pricing likely to land under competitive pressure?

For mature contrast media brands, pricing typically evolves from list-premium to parity-like net pricing under competitive contract outcomes. The practical pricing level depends on:

  • Region and tender participation (who bids and what contract coverage exists).
  • Whether the hospital uses a single preferred contrast supplier or multi-supplier framework.
  • Packaging format rationalization (units per vial, kit bundling, and admin equipment compatibility).

Without product-level net price disclosure, the most decision-useful way to read trajectory is by procurement behavior:

  • When Omnipaque retains preferred listing across major hospital groups, revenue holds by volume.
  • When Omnipaque loses a tender, revenue shifts to lower-volume accounts and smaller pack conversions, with net price and volume both affected.

What are the business implications for R&D and investment decisions?

For R&D planning

  • Differentiation must be procurement-relevant: In mature contrast categories, differentiation that changes dosing workflow, reduces waste, or aligns with high-throughput protocols performs better in tendering.
  • Manufacturing reliability is a commercial moat: Supply interruptions can quickly cause loss of preferred supplier status even if safety is unchanged.

For investment modeling

  • Model revenue using procedure volume proxy + procurement share:
    • Procedure mix and CT utilization drive baseline consumption.
    • Procurement share drives net revenue and margin.
  • Use scenario bands around tender cycles rather than relying on scientific milestones for this class.

Market dynamics by demand segment (how volume can move)

Omnipaque 210 usage is most sensitive to:

  • CT angiography share: Higher angiography prevalence increases average contrast exposure per patient.
  • Emergency and inpatient imaging intensity: Acute settings maintain contrast utilization even when elective imaging slows.
  • Chronic outpatient imaging mix: Elective imaging volumes can swing with reimbursement and healthcare budget cycles.

Revenue trajectory therefore depends on whether the system’s imaging mix shifts toward higher-contrast-demand CT procedures.

Key Takeaways

  • Omnipaque 210’s financial trajectory follows mature iodinated contrast dynamics: volume tracks CT utilization while net revenue depends on tender and formulary share.
  • Competitive pressure in mature iohexol markets typically drives net price compression after generic or alternate suppliers win contracts.
  • The most material offset to price erosion is volume resilience from CT angiography and protocol standardization at high-volume hospital systems.
  • Supply continuity and procurement execution are commercial determinants that influence whether the brand keeps preferred status.
  • Product-level exclusivity is not the main driver of long-term revenue in this category; contract cycles and switching friction are.

FAQs

1) Is Omnipaque 210 primarily driven by patent exclusivity?

No. For mature iodinated contrast products, revenue is primarily shaped by hospital procurement cycles, competitive tender outcomes, and generic or alternate supplier penetration rather than patent-driven brand protection.

2) What most strongly influences Omnipaque 210 revenue?

CT and CT angiography utilization volume, combined with the brand’s formulary and tender share at major hospital systems.

3) How do hospital tenders typically impact contrast media pricing?

Tenders usually reset net pricing downward when competing products or generics gain preferred listing, while switching friction slows declines but does not stop them.

4) What are the biggest risks to the financial trajectory of Omnipaque 210?

Loss of preferred supplier status in major contracts, accelerated generic substitution, and any supply disruption that causes allocation or loss of inventory position.

5) What factors can help stabilize revenue despite price pressure?

Protocol standardization, sustained CT throughput in key regions, and high supply reliability that helps the brand retain preferred status.


References (APA)

[1] U.S. Food and Drug Administration. (n.d.). Labeling for Omnipaque (iohexol). FDA. https://www.accessdata.fda.gov/
[2] European Medicines Agency. (n.d.). Omnipaque (iohexol) product information. EMA. https://www.ema.europa.eu/
[3] GE HealthCare. (n.d.). Investor relations and financial reporting. GE HealthCare. https://www.gehealthcare.com/investor-relations

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