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Last Updated: December 12, 2025

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. Three 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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  • What is the 5 year forecast for OMNIPAQUE 210?
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Drug patent expirations by year for OMNIPAQUE 210
Recent Clinical Trials for OMNIPAQUE 210

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 210 clinical trials

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 ⤷  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

Market Dynamics and Financial Trajectory for OMNIPAQUE 210

Last updated: July 30, 2025

Introduction

OMNIPAQUE 210, a contrast agent developed by Guerbet, is used in radiographic imaging procedures to enhance visualization of vascular and tissue structures. This ionic, iodine-based contrast medium is primarily employed in computed tomography (CT) scans. As a pivotal component in diagnostic imaging, OMNIPAQUE 210's market performance is subject to multifaceted dynamics driven by technological innovations, regulatory landscapes, healthcare infrastructure, and competitive factors. This report explores the current market environment, the trajectory of its financial prospects, and key determinants influencing its future.

Market Dynamics

1. Growing Demand for Diagnostic Imaging

The global expansion of diagnostic imaging, especially CT scans, directly fuels the demand for contrast agents like OMNIPAQUE 210. According to Market Research Future, the global CT imaging market is projected to reach USD 16.1 billion by 2027, growing at a compound annual growth rate (CAGR) of approximately 5.7% from 2020 to 2027[1]. This trend is driven by the increasing prevalence of chronic diseases, cancer screening programs, and advancements in imaging technology providing clearer, faster results. As a widely accepted contrast medium for CT, OMNIPAQUE 210 benefits from this overarching market growth.

2. Technological Advancements in Imaging

Innovations such as high-resolution multi-detector CT scanners and the development of low-osmolar contrast agents contribute to changing preferences and regulatory standards. The shift towards low-osmolar and iso-osmolar agents tailored for improved safety profiles has pressured older, higher-osmolar agents like OMNIPAQUE 210 to innovate or reposition in the market. Nonetheless, OMNIPAQUE’s established efficacy and safety profile sustain its relevance, especially within institutions adhering to existing protocols.

3. Regulatory Environment and Safety Concerns

Regulatory agencies, including the FDA and EMA, scrutinize contrast agents for adverse effects such as allergic reactions and nephrotoxicity. Omnipaque 210's ionic iodine configuration has a well-documented safety profile, but concerns over contrast-induced nephropathy (CIN) have prompted healthcare providers to prioritize newer agents with improved safety margins. Regulatory restrictions and pricing pressures influence prescription patterns, potentially constraining growth but also opening niches for newer formulations.

4. Competition and Market Share

OMNIPAQUE faces competition from non-ionic, lower-osmolar agents such as iopamidol, ioversol, and iohexol. These alternatives often display improved safety profiles and comparable imaging quality. The proprietary positioning, brand recognition, pricing strategies, and distribution networks of Guerbet influence OMNIPAQUE’s ability to sustain market share. Moreover, increasing adoption of MRI contrast agents and non-iodine based imaging modalities pose a threat to iodine-based contrast agents' dominance.

5. Healthcare Infrastructure and Geographic Variations

Developed markets like North America and Europe possess advanced healthcare infrastructure with high adoption rates of advanced imaging technologies. These regions historically generate significant revenue streams for contrast agents. Conversely, emerging markets present growth opportunities owing to expanding healthcare access and increasing CT scan utilization. However, pricing sensitivity and regulatory complexities may constrain rapid expansion in some regions.

6. COVID-19 Pandemic Impact

The COVID-19 pandemic initially disrupted elective imaging procedures, temporarily reducing contrast agent consumption. However, the subsequent surge in diagnostic testing and increased emphasis on imaging for COVID-related complications contributed to a rebound in demand. Long-term, pandemic-induced shifts towards telehealth and digital diagnostics may influence the growth trajectory for contrast media like OMNIPAQUE 210.

Financial Trajectory

1. Revenue Trends

Guerbet’s financial reports indicate that contrast media, including variants of OMNIPAQUE, comprise a significant portion of its revenue. While precise figures for OMNIPAQUE 210 are proprietary, the segment witnessed steady growth aligned with global imaging demand. The CAGR in contrast media segment has historically ranged between 4-6%, with a stable outlook bolstered by expanding imaging needs[2].

2. Price Dynamics and Market Penetration

Pricing strategies are pivotal, especially in markets with constrained healthcare budgets. Guerbet's reputation and established distribution channels provide pricing leverage, but increasing competition exerts downward pressure. The company's focus on product differentiation, safety enhancements, and targeted marketing influences revenue stability and growth.

3. R&D and Product Portfolio Expansion

Guerbet invests heavily in R&D to develop next-generation contrast agents that can replace older formulations like OMNIPAQUE 210. The transition towards lower-osmolar agents and the development of agents with improved safety profiles ensure continued relevance. These innovations may phase out older formulations gradually, impacting short- to medium-term revenues but promising long-term growth.

4. Regulatory and Patent Landscape

Patent protections for OMNIPAQUE 210 have largely expired or are nearing expiration, exposing the molecule to generic competition. Generic versions typically enter the market at lower prices, which can erode revenue streams. Guerbet's strategic focus on branding, safety, and clinical efficacy aims to maintain market share despite the patent challenges.

5. Market Expansion Opportunities

Emerging markets offer significant revenue potential driven by increasing healthcare infrastructure, rising disease burdens, and favorable governmental initiatives. Guerbet's targeted market strategies, including partnerships and local manufacturing, are crucial for tapping these opportunities. The company's revenue contribution from these regions is expected to grow at a CAGR exceeding 6%, outpacing mature markets.

Future Outlook

The financial and market outlook for OMNIPAQUE 210 hinges on several interrelated factors:

  • Innovation and Differentiation: The development of next-generation contrast agents with superior safety profiles could dilute the market share of OMNIPAQUE 210. However, continued improvements and clinical validation may sustain its relevance.

  • Market Penetration in Emerging Regions: Accelerated growth in India, China, and Southeast Asia presents robust opportunities, leveraging economic development and healthcare expansion.

  • Regulatory Landscape: Stringent safety standards and evolving guidelines may favor newer agents, but established clinical efficacy of OMNIPAQUE 210 ensures its ongoing utility.

  • Competitive Pricing and Partnerships: Strategic alliances and competitive pricing will be crucial for retaining market share amid generics and new entrants.

  • Technological Innovation in Imaging: As imaging modalities diversify, the role of iodine-based contrast agents may experience transformation, influencing long-term financial trajectories.

Key Takeaways

  • The market for contrast agents like OMNIPAQUE 210 is driven by expanding diagnostic imaging services, technological advances, and healthcare infrastructure development, especially in emerging markets.

  • Despite competition and regulatory challenges, OMNIPAQUE 210 remains a vital option due to its established safety profile and clinical efficacy.

  • Patent expirations and the rise of generic competitors necessitate strategic differentiation through safety, efficacy, and cost management.

  • Healthcare trends towards personalized medicine and novel imaging techniques may reshape demand, favoring innovative contrast media.

  • Guerbet's focus on R&D, regional expansion, and safety enhancements will be pivotal in maintaining and growing OMNIPAQUE's market share.

Conclusion

OMNIPAQUE 210’s market outlook is characterized by steady growth amid evolving competition, regulatory pressures, and technological transformations. While challenges persist, particularly from proprietary generics and newer contrast agents, strategic adaptability and regional expansion can bolster its financial trajectory. Long-term success hinges on continual innovation, regulatory compliance, and tailored marketing to meet the shifting landscape of diagnostic imaging.


FAQs

1. How does OMNIPAQUE 210 compare to non-ionic contrast agents?
OMNIPAQUE 210 is an ionic, high-osmolar agent, which historically has been effective but is associated with higher risk profiles, especially nephrotoxicity. Non-ionic, low-osmolar agents offer improved safety and tolerability, which increasingly influences prescribing trends.

2. What are the main factors impacting the pricing of OMNIPAQUE 210?
Pricing is affected by patent status, competition from generics, healthcare reimbursement policies, and regional economic conditions. Cost pressures in emerging markets also influence pricing strategies.

3. Are there any recent innovations in contrast agents that threaten OMNIPAQUE 210's market position?
Yes. The development of iso-osmolar, non-ionic agents with enhanced safety profiles, such as VISIPAQUE and iodixanol, are gaining favor, potentially limiting OMNIPAQUE’s growth.

4. What regions present the greatest growth opportunities for OMNIPAQUE 210?
Emerging markets in Asia-Pacific, Latin America, and parts of Africa exhibit substantial growth potential due to increasing healthcare investments, rising disease burdens, and expanding imaging infrastructure.

5. How might regulatory changes affect OMNIPAQUE 210’s future sales?
Stricter safety and efficacy standards could favor newer contrast agents, potentially squeezing sales of older formulations like OMNIPAQUE 210. Conversely, stability in regulatory approvals and safety assessments support ongoing use.


References

[1] Market Research Future, "Global CT Imaging Market Analysis," 2022.
[2] Guerbet Annual Report, 2022.

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