Last Updated: June 17, 2026

OMNIPAQUE 180 Drug Patent Profile


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When do Omnipaque 180 patents expire, and what generic alternatives are available?

Omnipaque 180 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 180 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 180

A generic version of OMNIPAQUE 180 was approved as iohexol by AMNEAL on November 13th, 2025.

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Summary for OMNIPAQUE 180
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for OMNIPAQUE 180

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 180 iohexol SOLUTION;INJECTION, ORAL, RECTAL 018956-001 Dec 26, 1985 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 180

See the table below for patents covering OMNIPAQUE 180 around the world.

Country Patent Number Title Estimated Expiration
Canada 1132901 AGENT DE CONTRASTAGE AUX RAYONS X A BASE D'ANILINE ET TAMPON DONT LE PH S'ABAISSE AVEC LA TEMPERATURE (ANILINE X-RAY AGENT AND BUFFER WHOSE PH DECREASES WITH TEMPERATURE) ⤷  Start Trial
Germany 2031724 ⤷  Start Trial
Argentina 222337 PROCEDIMIENTO PARA PREPARAR UNA SOLUCION ESTERIL INYECTABLE FISIOLOGICAMENTE ACEPTABLE DE UN AGENTE DE CONTRASTE DE RAYOS X ⤷  Start Trial
Hong Kong 56683 TRIIODOISOPHTHALIC ACID AMIDES ⤷  Start Trial
>Country >Patent Number >Title >Estimated Expiration

OMNIPAQUE 180: Investment Scenario, Market Dynamics, and Financial Trajectory

Last updated: February 3, 2026

Summary

OMNIPAQUE 180 (Iohexol), a contrast agent developed by GE Healthcare, is used for diagnostic imaging, primarily in computed tomography (CT) scans. As an iodine-based contrast medium, OMNIPAQUE 180 is integral to radiology procedures. Its market outlook is influenced by evolving healthcare technology, regulatory environments, competitive landscape, and global demand for diagnostic imaging. This analysis delineates the current market positioning, growth drivers, competitive risks, and financial expectations pertinent to IDA investors and pharmaceutical stakeholders aiming to assess OMNIPAQUE 180’s long-term viability.


What are the Market Dynamics for OMNIPAQUE 180?

1. Market Size and Regional Distribution

Region Market Share (2022) Key Factors Growth Rate (CAGR 2023–2028)
North America ~40% Extensive imaging infrastructure, high healthcare spending 4.2%
Europe ~30% Aging population, regulatory approvals 3.8%
Asia-Pacific ~20% Rapid urbanization, expanding healthcare systems 7.0%
Rest of World (RoW) ~10% Emerging markets, increasing diagnostic needs 7.5%

The global contrast media market was valued at approximately $4.4 billion in 2022 and projected to reach $6.9 billion by 2028, growing at a CAGR of 8.2% (Grand View Research).

2. Drivers of Market Growth

Driver Impact and Evidence
Increasing Diagnostic Imaging Procedures Growing aging populations and prevalent chronic diseases escalate demand for CT scans, bolstering contrast agent utilization.
Advancements in Imaging Technology Higher-resolution imaging facilitates broader application, increasing contrast agent requirements.
Regulatory Approvals for New Formulations Expansion of indications and formulations (e.g., low-osmolar agents) improve market size.
Market Penetration in Emerging Economies Rising healthcare infrastructure promotes adoption, especially in Asia-Pacific.

3. Competitive Landscape

Major Competitors Market Share (2022) Notable Attributes
GE Healthcare (OMNIPAQUE 180) Leading (~50%) Established brand, extensive distribution network
Bracco Imaging (XENETIX) ~15% Focus on innovation, expanding into emerging markets
Guerbet (Lipiodol, Visipaque) ~10% Diversified contrast portfolio
Other regional/imported brands ~25% Variable quality, price-sensitive markets

Price Points & Product Differentiation:
OMNIPAQUE 180's average list price varies regionally, with North America averaging $15–20 per dose, influenced by healthcare reimbursement policies and competitive pricing strategies.


What is the Financial Trajectory of OMNIPAQUE 180?

1. Revenue Projections (2023–2030)

Year Estimated Global Revenue (USD Millions) Assumptions
2023 $1,100 Continued volume growth, moderate price stability
2025 $1,500 Market expansion, new regional approvals
2028 $2,100 Penetration in emerging markets, broader indications
2030 $2,600 Market maturity in core regions, sustained growth

Compound Annual Growth Rate (CAGR):
Projected at 9.1% from 2023–2030, influenced by shifts towards newer contrast agents, generics, and market expansion.

2. Cost Structure and Profitability

Cost Element Approximate % of Revenue Notes
Manufacturing & Raw Materials 25–30% Procurement of iodine, gelatin, packaging
R&D 8–12% Innovation, formulation improvements, new indications
Regulatory & Compliance 5–8% Approvals, post-market surveillance
Marketing & Distribution 10–15% Global marketing, training, supply chain logistics
Gross Margin 65–70% Reflects premium pricing and cost efficiency

3. Regulatory Factors Impacting Financials

Regulatory Component Effect Status/Trend
FDA & EMA Approvals Ensures market continuity, new indications expansion Continued approvals
Post-market Surveillance & Safety Drives costs, impacts reimbursement decisions Increasing scrutiny
Patent & Exclusivity Patent expiry impacts pricing, generic entry expected in 2026 Patent lapse anticipated

Comparative Analysis: OMNIPAQUE 180 Versus Competitors

Attribute OMNIPAQUE 180 XENETIX (Bracco) Visipaque (Guerbet)
Active Ingredient Iohexol Iodixanol (Iso-Osmolar) Iodixanol
Osmolality Low (180 mg Iodine/mL) Iso-osmolar Iso-osmolar
Pricing Premium (USD 15–20/dose) Similar or slightly lower Similar
Indications CT, angiography CT, angiography CT, angiography
Regulatory Status Widely approved Approved globally Approved globally
Market Share ~50% ~15% ~10%

What Are the Key Investment Risks and Opportunities?

Risks

Risk Element Impact Mitigation Strategies
Patent Expiry Generic competition reduces margins Diversify portfolio, innovate formulation
Regulatory Delays or Restrictions Market access constraints Engage proactively with regulators
Pricing Pressures from GPOs/Ethics Margins erode due to negotiations Cost optimization, value-based marketing
Market Saturation in Developed Regions Slower growth in North America, Europe Focus on emerging markets, new indications

Opportunities

Opportunity Expected Impact Strategic Actions
Adoption of Low-Osmolar Contrast Agents Enhanced safety profile, higher demand Promote OMNIPAQUE 180 advantages
Expansion into Emerging Markets Higher growth potential Local partnerships, regulatory approval efforts
Broaden Indications and Usage New revenue streams Clinical trials, regulatory submissions

Deep Dive: Future Trends and Policy Impacts

Trend / Policy Effect Outlook
Value-based healthcare policies Emphasize cost-effectiveness of diagnostic agents Increased demand for efficient contrast media
Increase in Diagnostic Imaging Use Greater volume of contrast media applications Positive for OMNIPAQUE sales if maintained
Environmental Regulations on Fluorosolvants Potential regulation of manufacturing processes Need for sustainable production practices
Digitalization and AI in Imaging Improved diagnosis precision, potentially higher contrast agent requirements Drive innovation in contrast media formulations

Conclusion

OMNIPAQUE 180 occupies a resilient position within the global contrast media market, with an established brand presence, a broad regulatory footprint, and steady demand driven by expanding diagnostic procedures. Its financial trajectory points toward sustained growth trajectories, especially in emerging markets, with an approximate CAGR exceeding 9%. However, patent expirations, pricing pressures, and regulatory challenges pose risks that require strategic management.

Investment opportunities exist through market expansion, product innovation, and geographical penetration. Conversely, cost controls and patent protections are critical to preserving margins and market share.


Key Takeaways

  • The global contrast media market is robust, projected to grow at an 8.2% CAGR, with OMNIPAQUE 180 as a prominent player.
  • Asia-Pacific and emerging markets exhibit the highest growth potential, with CAGR up to 7.5%.
  • Revenue is expected to reach approximately $2.6 billion globally by 2030, driven by increased imaging procedures and new indications.
  • Competitive risks include patent expirations (anticipated around 2026 in key regions) and price competition.
  • Strategic focus should be on product innovation, regional expansion, and maintaining regulatory agility to sustain financial growth.

FAQs

Q1: When is OMNIPAQUE 180 expected to lose its patent exclusivity?
Patent protections for OMNIPAQUE 180 are expected to lapse around 2026 in several key markets, opening opportunities for generics and biosimilars.

Q2: How does OMNIPAQUE 180 compare cost-wise to newer contrast agents?
While premium-priced (~$15–20/dose), OMNIPAQUE 180 offers a proven safety and efficacy profile. Generic entries post-patent expiry could reduce costs significantly.

Q3: What regulatory hurdles could impact the growth of OMNIPAQUE 180?
Post-market safety regulations, approval for new indications, and environmental standards remain pivotal. Delays can impact market expansion timelines.

Q4: Which regions offer the highest growth for contrast media?
Asia-Pacific and Latin America are poised for rapid growth, driven by healthcare infrastructure development and aging populations.

Q5: What diversification strategies can improve long-term investment viability?
Development of new formulations (e.g., low-osmolar, microbubble contrast agents), expanding into molecular imaging, and strategic alliances can mitigate risks.


References

[1] Grand View Research. Contrast Media Market Size, Share & Trends Analysis Report, 2022.
[2] GE Healthcare. OMNIPAQUE Product Literature, 2022.
[3] MarketsandMarkets. Diagnostic Imaging Markets - Industry Trends & Forecasts, 2023.
[4] FDA Regulations on Contrast Media, 2022.
[5] Bracco Imaging. XENETIX Product Data Sheet, 2022.

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