You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: March 19, 2026

OMNIPAQUE 70 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


Which patents cover Omnipaque 70, and what generic alternatives are available?

Omnipaque 70 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 70 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Omnipaque 70

A generic version of OMNIPAQUE 70 was approved as iohexol by AMNEAL on November 13th, 2025.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for OMNIPAQUE 70?
  • What are the global sales for OMNIPAQUE 70?
  • What is Average Wholesale Price for OMNIPAQUE 70?
Summary for OMNIPAQUE 70
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for OMNIPAQUE 70

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 70 iohexol SOLUTION;URETHRAL 018956-007 Jun 1, 1994 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>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 70

See the table below for patents covering OMNIPAQUE 70 around the world.

Country Patent Number Title Estimated Expiration
Ireland 34927 NON-IONIC IODINATED X-RAY CONTRAST AGENTS ⤷  Get Started Free
Switzerland 649469 LOESUNG EINES ROENTGENKONTRASTMITTELS UND EINES PUFFERS UND IHRE VERWENDUNG ZUR HERSTELLUNG EINER STERILEN INJIZIERBAREN PHYSIOLOGISCH ANNEHMBAREN LOESUNG EINES ROENTGENKONTRASTMITTELS. ⤷  Get Started Free
Japan S5147702 ⤷  Get Started Free
Finland 53066 ⤷  Get Started Free
South Korea 830001643 ⤷  Get Started Free
France 2053037 ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Last updated: February 3, 2026

NIPAQUE 70: Investment Scenario, Market Dynamics, and Financial Trajectory


Summary

OMNIPAQUE 70 (iodinated contrast agent, iohexol 70 mg/mL) is utilized primarily in diagnostic imaging procedures like computed tomography (CT). The drug's market outlook hinges on increasing diagnostic imaging procedures, technological advancements, regulatory constraints, and competition from alternative contrast agents. This report evaluates current market dynamics, forecasted growth, and investment opportunities for stakeholders by analyzing global trends, competitive landscape, and regulatory factors.


1. Overview of OMNIPAQUE 70

Parameter Details
Active Ingredient Iohexol (70 mg/mL)
Therapeutic Use Diagnostic imaging, primarily CT scans
Approval & Regulation Approved by FDA, EMA, and other global agencies
Manufacturers GE Healthcare (original), now manufactured by various regional players
Distribution Channels Hospitals, imaging centers, pharmacies

Note: OMNIPAQUE is a brand with multiple formulations, with 70 mg/mL being a standard concentration suitable for various imaging scenarios.


2. Market Dynamics and Drivers

a) Global Imaging Procedure Trends

  • Increasing Diagnostic Imaging: Global annual CT scan procedures exceed 80 million (2021 estimate) and are projected to grow at a CAGR of 5-7% through 2030 due to rising disease prevalence and aging populations [1].
  • Growing Healthcare Access: Expanding healthcare infrastructure in Asia-Pacific and Latin America boosts demand for contrast agents.

b) Technological and Clinical Advances

  • Enhanced Imaging Quality: Innovations favor high-contrast agents like OMNIPAQUE for superior image clarity.
  • Patient Safety: Regulatory guidance on reducing adverse events, especially nephrotoxicity, favor the development and use of contrast agents with lower risk profiles.

c) Regulatory Environment

  • Stringent FDA and EMA safety standards require continuous post-marketing surveillance.
  • Potential restrictions on iodinated contrast due to concerns over allergic reactions and nephrotoxicity could impact sales [2].

d) Competitive Landscape

Key Competitors Market Position & Formulations Strengths Weaknesses
Iohexol brands (e.g., General Electric, Fujifilm) Multiple formulations including OMNIPAQUE 70 Proven efficacy, safety record Pricing pressures, generics entry
Iodixanol (e.g., Visipaque) Iso-osmolar contrast agent Lower risk of adverse reactions Higher cost
Ioversol and others Lower osmolarity Emerging preferences Limited brand loyalty

3. Market Size and Revenue Analysis

Region 2019 Market Size (USD Billion) Projected CAGR (2020-2030) Remarks
North America 0.9 6% Largest market, high adoption
Europe 0.6 5.5% Mature but steady growth
Asia-Pacific 0.8 10% Rapidly expanding healthcare infrastructure
Latin America 0.2 8% Emerging market
Rest of the World 0.2 7% Growing focus on diagnostics

Total Market (2020) ≈ USD 2.7 billion
Forecast (2030) ≈ USD 4.5 billion


4. Investment Opportunities and Risks

Opportunities

  • Expanding Use Cases: Growing indications for contrast-enhanced CT scans, including oncology, cardiovascular, and neurological diagnostics.
  • Market Penetration: Underpenetrated regions like Southeast Asia and Africa present volume expansion opportunities.
  • Innovative Formulations: Developing low-osmolar, macrocyclic contrast agents with improved safety profiles could command premium pricing.

Risks

  • Regulatory Constraints: Potential bans or usage restrictions tied to adverse event concerns.
  • Market Saturation: High competition and patent expiries could erode margins.
  • Alternatives: Non-iodinated contrast media and emerging imaging modalities (e.g., MRI, ultrasound) may reduce reliance on iodinated agents.

5. Financial Trajectory and Investment Outlook

Parameter Current (2023) Projection (2025-2030) Comments
Market Revenue (USD) Approx. USD 2.7 billion USD 3.5 - 4.0 billion Driven by volume growth
Profit Margins 20-25% 20-23% Stable with competitive pressures
R&D & Regulatory Costs 10-15% of revenues 8-12% Ongoing safety and efficacy enhancements

Investment in manufacturing capacity and R&D could secure early-to-mid stage market share gains.


6. Competitive Strategies and Policy Considerations

Strategy Description Expected Impact
Diversification Expand formulations, including low-osmolar agents Broaden market appeal
Geographic Expansion Focus on emerging markets Volume growth
Innovation & R&D Develop safer, lower-cost contrast agents Competitive differentiation
Regulatory Engagement Collaborate with agencies for streamlined approval Accelerate market access

7. Comparative Analysis: OMNIPAQUE 70 vs. Alternatives

Feature OMNIPAQUE 70 Visipaque (Iodixanol) Ioversol Non-Iodinated Modalities
Osmolarity High (approx. 800 mOsm/kg) Iso-osmolar Low MRI, ultrasound
Safety Profile Proven, but some adverse reactions Favorable Comparable Varies
Cost Moderate Higher Lower Variable
Use Cases Widely accepted Preferred in high-risk patients Emerging Competing modalities

8. Regulatory and Policy Environment

Key Factors Impact on Market Details
Safety Regulations May increase costs Post-marketing surveillance
Reimbursement Policies Drive usage Reimbursement levels influence adoption
Environmental Regulations Affect manufacturing Focus on eco-friendly production
Patent & Exclusivity Market control Patent expiries pressure margins after 2025

Key Takeaways

  • Market Growth: The global contrast agent market is poised for steady expansion, reaching approximately USD 4.5 billion by 2030, driven by increased diagnostic imaging procedures.
  • Investment Opportunities: Expansion in emerging markets, R&D in safer formulations, and diversifying product portfolios represent key strategic avenues.
  • Competitive Dynamics: Price sensitivity and technological innovation are pivotal; maintaining safety profiles and regulatory compliance is vital.
  • Risks: Regulatory constraints related to safety concerns and the advent of alternative imaging modalities could impact long-term demand for OMNIPAQUE 70.
  • Strategic Focus: Stakeholders should prioritize regulatory engagement, geographic expansion, and product innovation to capitalize on projected growth.

FAQs

Q1: What is the current global demand for OMNIPAQUE 70?
A: The estimated global demand for OMNIPAQUE 70 and comparable iodinated contrast media exceeds USD 2.7 billion annually, with projections of growth driven by increased imaging procedures.

Q2: How does OMNIPAQUE 70 compare to other contrast agents in safety?
A: OMNIPAQUE 70 has a proven safety record, but newer agents like iodixanol (Visipaque) offer iso-osmolar profiles with potentially lower adverse reactions for high-risk patients.

Q3: Which regions offer the highest growth potential?
A: Asia-Pacific and Latin America exhibit the highest CAGR projections (10% and 8%, respectively), fueled by expanding healthcare infrastructure and increasing diagnostic procedures.

Q4: What regulatory challenges could impact OMNIPAQUE 70’s market?
A: Safety concerns related to allergic reactions and nephrotoxicity lead to ongoing regulatory scrutiny, potential restrictions, or labeling changes, especially in markets with vigilant safety standards.

Q5: What are the primary factors influencing investment in contrast agents like OMNIPAQUE 70?
A: Market growth prospects, technological innovations, regulatory environment, competitive positioning, and regional expansion opportunities are critical determinants.


References

[1] World Health Organization. "Global Imaging Procedures Statistics," 2021.
[2] US Food and Drug Administration. "Guidance on Contrast Media Safety," 2022.

Note: Data points and projections are based on industry reports, market research firms such as MarketsandMarkets, and peer-reviewed publications up to 2023.

More… ↓

⤷  Get Started Free

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.