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Last Updated: December 12, 2025

OMNIPAQUE 9 Drug Patent Profile


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When do Omnipaque 9 patents expire, and what generic alternatives are available?

Omnipaque 9 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 9 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 9

A generic version of OMNIPAQUE 9 was approved as iohexol by AMNEAL on November 13th, 2025.

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Drug patent expirations by year for OMNIPAQUE 9
Recent Clinical Trials for OMNIPAQUE 9

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SponsorPhase
University of California, San DiegoPHASE2
Breakthrough T1DPHASE2
Claire BourgeoisPhase 4

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Pharmacology for OMNIPAQUE 9

US Patents and Regulatory Information for OMNIPAQUE 9

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 9 iohexol SOLUTION;ORAL 018956-008 Apr 17, 2018 RX Yes Yes ⤷  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 9

Last updated: August 3, 2025


Introduction

OMNIPAQUE 9, a low-osmolar contrast agent used primarily in diagnostic imaging procedures such as computed tomography (CT), occupies a significant niche within the diagnostic radiology market. Approved by regulatory authorities like the US FDA and numerous international counterparts, OMNIPAQUE 9’s market prospects depend heavily on technological advancements, competitive landscape, regulatory shifts, and healthcare industry trends. This analysis delineates the key market dynamics shaping OMNIPAQUE 9’s current landscape and projects its financial trajectory amid evolving global healthcare demands.


Market Overview of Contrast Agents

Contrast agents like OMNIPAQUE 9, whose active ingredient is iohexol, facilitate enhanced visualization of tissues and vasculature during imaging. The global contrast media market has experienced consistent growth driven by increasing prevalence of cardiovascular and neurological disorders, expanding imaging procedures, and technological innovations. The global contrast media market was valued at approximately USD 4.2 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of around 4.0-4.5% through 2030[1].

OMNIPAQUE's segment within this market targets high-end diagnostic procedures, especially in developed healthcare markets. Its utilization depends on several factors including healthcare infrastructure, physician preferences, and reimbursement policies.


Market Drivers for OMNIPAQUE 9

1. Rising Global Imaging Procedures:
The global increase in CT scans, driven by an aging population, rising incidence of chronic diseases, and broadening diagnostic indications, sustains demand for contrast agents. The number of annual CT scans worldwide exceeds 100 million, with a forecasted CAGR of 4-5% in the coming decade[2].

2. Focus on Patient Safety and Contrast Agent Advances:
OMNIPAQUE 9’s low-osmolar profile offers a safety advantage over older high-osmolar agents, reducing risks like contrast-induced nephropathy (CIN). Such safety profiles become increasingly crucial in vulnerable populations, such as those with CKD or diabetes, driving incremental adoption.

3. Technological Innovations:
Advances in imaging technology have led to more precise, higher-resolution diagnostics necessitating superior contrast agents. As these technologies evolve, demand for high-quality, low-risk contrast media like OMNIPAQUE 9 benefits.

4. Expansion into Emerging Markets:
Increasing healthcare investments in Asia-Pacific, Latin America, and Eastern Europe, coupled with improving healthcare infrastructure, expands potential customer bases for contrast media. Growing middle-class populations and increased health awareness catalyze uptake in these regions.

5. Regulatory Approvals and Reimbursement Policies:
Stringent safety profiles favor agents like OMNIPAQUE 9, fostering favorable regulatory environments. Additionally, favorable reimbursement policies in developed markets encourage continued utilization and growth.


Market Challenges and Constraints

1. Competition from Generics and Alternative Agents:
The contrast media market is highly commoditized. Several generic iohexol formulations, often priced lower, threaten OMNIPAQUE 9’s market share. Notably, brands like GE Healthcare’s Omnipaque and other competitors such as Amersham’s Visipaque maintain dominance.

2. Regulatory and Safety Concerns:
Despite its safety profile, challenges remain around contrast-induced adverse events. Additionally, the recent scrutiny of iodinated contrast agents’ safety, especially in patients with renal impairment, pressures the industry to improve formulations and expand safety data.

3. Cost Containment and Reimbursement Pressures:
Healthcare providers face cost-containment pressures, favoring generic alternatives. Reimbursement policies, especially in countries with tightening healthcare budgets, can impact margins.

4. Impact of COVID-19:
The pandemic disrupted elective imaging procedures, causing temporary declines in contrast agent utilization. Although recovery is underway, the residual impact influences near-term demand estimate adjustments.


Regional Market Dynamics

North America:
Dominant market driven by high utilization rates, advanced healthcare infrastructure, and emphasis on diagnostic precision. The US accounts for over 45% of global contrast media revenues, with growth supported by initiatives like Precision Medicine.

Europe:
Second-largest market, characterized by strong healthcare systems and regulatory frameworks. Growth driven by aging populations and adoption of new imaging modalities.

Asia-Pacific:
Fastest-growing segment, fueled by rising healthcare spending, population aging, and increasing adoption of advanced imaging technologies. The region is experiencing significant growth potential despite challenges like regulatory hurdles and pricing pressures.

Latin America & Middle East:
Emerging markets offering substantial growth opportunities, particularly with expanding healthcare access and infrastructure investments.


Financial Trajectory and Revenue Outlook

The financial prospects of OMNIPAQUE 9 hinge on several macroeconomic and industry-specific factors:

  • Market Penetration:
    Current penetration remains healthy in developed markets. However, competition from generics constrains pricing power, leading to margins that are under pressure.

  • Pricing Trends:
    While branded contrast agents command premium pricing, price erosion due to generics is ongoing. Industry forecasts suggest a decline in average selling prices (ASPs) of approximately 2-4% annually over the next five years.

  • Volume Growth:
    Estimated volume growth is projected at 3-4% annually, driven by increasing imaging procedures, expanding indications, and adoption in emerging markets.

  • Revenue Projections:
    Based on these parameters, the global revenue for OMNIPAQUE 9 can be anticipated to grow modestly at a CAGR of around 2-3% over the next five years, reaching approximately USD 600-700 million by 2030 from a 2022 baseline of roughly USD 500 million[3].

  • Profitability Outlook:
    Margins may face headwinds owing to pricing pressures, but volume-driven growth and efficiencies in manufacturing could mitigate some impacts. Innovative formulations or new indications could serve as revenue catalysts.


Strategic Growth Opportunities

1. Portfolio Diversification:
Expanding into alternative imaging modalities or developing targeted contrast agents for specific indications, such as neurovascular procedures, enhances growth prospects.

2. Geographic Expansion:
Investing in emerging markets with infrastructural development and increasing healthcare budgets could augment revenues.

3. Innovation and R&D:
Advancements in contrast media with improved safety profiles, reduced side effects, or tailored formulations for specific patient populations can give competitive advantages.

4. Partnership and Licensing Agreements:
Collaborations with local distributors or technology partners can facilitate market access and accelerate growth.


Regulatory and Market Outlook

The regulatory environment continues to prioritize patient safety, reinforcing the importance of rigorous clinical data demonstrating efficacy and safety. Future approval pathways may favor agents with proven safety profiles, bolstering OMNIPAQUE 9’s prospects. Global efforts to adopt standardized imaging protocols could also influence usage patterns positively.


Key Takeaways

  • Growing Imaging Demand: The rising global volume of CT and diagnostic imaging procedures primarily sustains demand for contrast agents like OMNIPAQUE 9.
  • Competitive Landscape: Price erosion due to generics and alternative agents constrains revenue growth, demanding strategic differentiation.
  • Regional Opportunities: Emerging markets offer substantial upside, supported by healthcare infrastructure investments and rising health awareness.
  • Innovation as a Differentiator: Advances in formulation, safety, and indication expansion remain critical to maintaining competitive edge and profitability.
  • Moderate Growth Forecast: Industry projections suggest a stable but modest growth trajectory, averaging 2-3% CAGR over the next five years, with revenues potentially reaching USD 600-700 million globally.

FAQs

1. What distinguishes OMNIPAQUE 9 from other contrast agents?
OMNIPAQUE 9’s low-osmolar profile offers enhanced safety and reduced adverse reactions compared to older high-osmolar agents. Its pharmacokinetic properties make it suitable for a broad range of diagnostic imaging, with particular advantages in vulnerable patient populations.

2. How does the competitive landscape impact OMNIPAQUE 9’s market share?
The market faces intense competition from generic iohexol formulations, which exert downward pressure on prices and margins. While brand loyalty and clinical preference support current usage, continual innovation and pricing strategies are vital to sustain market position.

3. What role do regulatory factors play in OMNIPAQUE 9’s growth?
Regulatory authorities emphasize patient safety and efficacy, favoring agents with comprehensive safety data. Recent updates and approvals in emerging markets can facilitate market expansion, whereas safety concerns may restrict use in certain populations.

4. How will global demographic trends influence demand?
An aging global population and increasing prevalence of chronic illnesses will likely sustain demand for diagnostic imaging, thereby supporting OMNIPAQUE 9’s growth. The expansion into emerging markets further amplifies this trend.

5. What are the key risks facing OMNIPAQUE 9’s market outlook?
Risks include intensified competition, regulatory restrictions, pricing pressures, and potential safety concerns related to contrast media. Additionally, healthcare policy changes or reimbursement policies could impact utilization rates.


References

[1] MarketsandMarkets, "Contrast Media Market by Type, Application, and Region," 2022.
[2] Global Diagnostic Imaging Market Report, 2022.
[3] Company internal projections and industry analyses, 2023.

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