Last Updated: May 10, 2026

OMNIPAQUE 12 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Omnipaque 12, and what generic alternatives are available?

Omnipaque 12 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 12 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 12

A generic version of OMNIPAQUE 12 was approved as iohexol by AMNEAL on November 13th, 2025.

  Start Trial

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for OMNIPAQUE 12?
  • What are the global sales for OMNIPAQUE 12?
  • What is Average Wholesale Price for OMNIPAQUE 12?
Recent Clinical Trials for OMNIPAQUE 12

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

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

See all OMNIPAQUE 12 clinical trials

Pharmacology for OMNIPAQUE 12

US Patents and Regulatory Information for OMNIPAQUE 12

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 12 iohexol SOLUTION;ORAL 018956-009 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

OMNIPAQUE 12 Market Analysis and Financial Projection

Last updated: April 26, 2026

OMNIPAQUE 12: Market Dynamics and Financial Trajectory

What is OMNIPAQUE 12 and where does it sit in the commercial stack?

OMNIPAQUE 12 is an iodinated contrast media product (iohexol) marketed for diagnostic imaging. Its commercial role is tied to procedural volumes in radiology (CT and related imaging), tender-driven hospital purchasing, and competitive substitution among other iodinated contrast agents.

Market positioning is shaped by four structural forces:

  1. Imaging demand linkage: Sales track radiology volumes, especially CT utilization, procedure mix, and regional diagnostic spending.
  2. Purchasing mechanics: Hospital and group purchasing organizations (GPOs) drive price bands through formularies, tenders, and contract renewals.
  3. Supply chain and compliance: Manufacturing continuity for sterile injectables and regulatory upkeep influence continuity of supply, which can affect share during disruptions.
  4. Competitive substitution: The dominant competitive set is other nonionic, monomeric iodinated contrast media, typically compared on osmolality profile, viscosity curve, and patient tolerability, with price and contract status determining final uptake.

How do market dynamics move OMNIPAQUE 12 revenue?

OMNIPAQUE 12 revenue dynamics typically follow a repeatable pattern: volume resilience offset by pricing pressure and contract churn.

Key revenue drivers

  • Procedure volume: CT and angiography-related use are the main demand vector. When diagnostic volumes expand, contrast media consumption rises.
  • Contract pricing and rebates: Short procurement cycles and renegotiations can push net price down faster than list price.
  • Switching behavior: Switching often happens when contracts renew, when competitors win tenders, or when clinical preference shifts due to safety or workflow attributes.
  • Substitution within the class: Hospitals often treat iodinated contrast portfolios as interchangeable if administration and performance fit local protocols, limiting pricing power.

Key market frictions

  • Tender dispersion by geography: A product can hold stable share in one region and lose it in another when local vendors win procurement.
  • Conversion of “preferred” status: Once a product becomes formulary-linked for a network, share can stabilize. If it loses preferred status, the rebound is slower because switching requires training and protocol changes.
  • Regulatory and labeling continuity: Any changes to labeling, manufacturing site compliance, or availability can temporarily disrupt usage and distribution.

What does the competitive landscape imply for pricing and share?

The competitive set for iohexol-based iodinated contrast is concentrated around established brands and cost-competitive equivalents within iodinated contrast media.

Commercial implication for OMNIPAQUE 12:

  • Net price trends: Downward drift over time is common as contracts rotate toward lower-cost offerings or as multi-source competition tightens.
  • Share stability vs volatility: Share is usually stable when preferred supplier status lasts, but can shift quickly after procurement events.
  • Value narrative compression: Clinical differences matter at clinician level, but at procurement level contracts and total cost of ownership dominate.

How has OMNIPAQUE 12’s financial trajectory likely evolved over time?

A full financial history requires unit sales, net sales, and segment reporting by the marketing authorization holder. With only the drug name provided and without company-level financial disclosures, a complete and accurate financial trajectory cannot be produced.

What can be asserted from market structure (without inventing numbers)

  • Long-run trajectory: For established contrast agents, the trajectory typically moves through three phases:
    1. Growth on utilization expansion (procedure growth and formulary onboarding),
    2. Mature phase with price compression (contract renewals, tender competition),
    3. Late-life stabilization driven more by distribution reach and preferred status than by differentiated innovation.
  • Short-run earnings sensitivity: Revenue swings tend to follow procurement cycles and availability events more than R&D milestones, since contrast media product life cycles are operationally driven.

What are the principal levers affecting OMNIPAQUE 12 profitability?

Even without proprietary margin disclosures, the profitability model for iodinated contrast media is structurally consistent.

Cost and margin levers

  • Raw material and packaging economics: Iodine-based chemistry and sterile packaging costs influence gross margin stability.
  • Manufacturing scale and yield: Higher utilization of lines and improved yield reduces per-unit cost.
  • Logistics and cold-chain requirements: Temperature handling and distribution efficiency affect cost-to-serve.
  • Rebate and contracting strategy: Net pricing after rebates can determine whether volume growth offsets price cuts.
  • Product availability: Any supply interruption typically forces temporary substitution, raising short-term churn costs and reducing share recovery speed.

How does reimbursement and tendering affect revenue quality?

For hospital-centric pharmaceuticals like contrast agents, revenue quality hinges on:

  • Contract durability: Longer contracts reduce volatility.
  • Exclusivity clauses: Preferred status and switching penalties stabilize demand.
  • Administrative simplicity: Formulary inclusion and standardized procurement reduce internal friction.
  • Regional coverage and purchasing channels: Multi-channel distribution can stabilize volume, but each channel may carry different net price.

What would an investment-grade market/financial model require?

A robust trajectory model typically decomposes annual revenue into:

  • Units = number of imaging procedures × contrast utilization per procedure × share of iodinated contrast class
  • Net price = list price × (contract discounts + rebates - chargebacks)
  • Gross margin = net price - manufacturing - distribution - manufacturing overhead
  • Operating margin = gross margin - SG&A - pharmacovigilance/regulatory - logistics overhead

Without the missing inputs (net sales, units, contract pricing, and margin data), the trajectory cannot be stated with hard numbers.


Key Takeaways

  • OMNIPAQUE 12 is an iodinated contrast media product (iohexol) whose market dynamics track radiology procedure volumes and procurement cycles more than innovation-driven adoption.
  • Revenue and share are primarily shaped by tender-driven pricing, preferred supplier status, and substitution within the iodinated contrast class.
  • The likely financial pattern for established contrast agents is mature-market pricing compression with demand stability dependent on contract renewals and supply continuity.
  • A numerically specific financial trajectory cannot be produced from the information provided (no net sales, unit sales, pricing, or company disclosures are included).

FAQs

1) What market forces matter most for OMNIPAQUE 12?

Radiology procedure volumes, hospital procurement cycles, contract pricing, formulary status, and substitution among iodinated contrast agents are the dominant forces.

2) Does OMNIPAQUE 12 face pricing pressure?

Yes. Mature iodinated contrast markets commonly experience net price compression as tenders rotate and multi-source competition tightens.

3) What determines whether OMNIPAQUE 12 holds share?

Preferred supplier or formulary inclusion within hospital networks, plus consistent supply availability and contract continuity, typically decide share durability.

4) Are financial outcomes driven by R&D milestones?

For established contrast media products, near-term outcomes are more operational and commercial (tender cycles, supply, contracting) than R&D-driven.

5) What data is required to quantify its financial trajectory?

Unit sales, net selling price by geography and channel, contract and rebate structures, and product availability history.


References

[1] US Food and Drug Administration. OMNIPAQUE (iohexol) drug label and related regulatory information. https://www.accessdata.fda.gov/ (accessed 2026-04-26).
[2] European Medicines Agency. Product information for OMNIPAQUE (iohexol) and related EPAR documents. https://www.ema.europa.eu/ (accessed 2026-04-26).

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.