OMNIPAQUE 180 Drug Patent Profile

When do Omnipaque 180 patents expire, and when can generic versions of Omnipaque 180 launch?

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. Three 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 13^th, 2025.

Summary for OMNIPAQUE 180

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	26
Patent Applications:	4,175
DailyMed Link:	OMNIPAQUE 180 at DailyMed

Recent Clinical Trials for OMNIPAQUE 180

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

Sponsor	Phase
University of California, San Diego	PHASE2
Breakthrough T1D	PHASE2
Claire Bourgeois	Phase 4

See all OMNIPAQUE 180 clinical trials

Pharmacology for OMNIPAQUE 180

Drug Class	Radiographic Contrast Agent
Mechanism of Action	X-Ray Contrast Activity

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

Expired US Patents for OMNIPAQUE 180

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 180	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-001	Dec 26, 1985	4,021,481
Ge Healthcare	OMNIPAQUE 180	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-001	Dec 26, 1985	4,396,597
Ge Healthcare	OMNIPAQUE 180	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-001	Dec 26, 1985	4,250,113

International Patents for OMNIPAQUE 180

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

Country	Patent Number	Title	Estimated Expiration
Australia	523295
Germany	2031724
Netherlands	153083
Sweden	7706792

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OMNIPAQUE 180

Last updated: July 29, 2025

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Introduction

OMNIPAQUE 180, a contrast agent developed by GE Healthcare, is extensively utilized in diagnostic imaging, particularly for computed tomography (CT) scans. Its active ingredient, iohexol, enhances vascular and tissue contrast, facilitating accurate diagnosis across multiple medical domains, including neurology, oncology, and vascular imaging. Understanding the market dynamics and financial trajectory of OMNIPAQUE 180 involves analyzing factors such as regulatory landscapes, competitive positioning, technological advancements, and healthcare trends influencing demand and revenue streams.

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Regulatory Environment and Market Entry

The global approval of OMNIPAQUE 180 by regulatory authorities such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) has underpinned its commercial stability. The drug’s approval process involved comprehensive clinical trials confirming efficacy and safety, securing its status as a trusted contrast agent. However, evolving regulations aimed at minimizing contrast-induced nephropathy and ensuring patient safety often influence formulation modifications and usage protocols, impacting market dynamics.

Market access is further shaped by the reimbursement landscape across different regions. For instance, in North America, favorable reimbursement policies for diagnostic imaging support continued utilization, while in emerging markets, regulatory delays and reimbursement challenges can hinder growth. The combination of strict regulatory oversight and the need for ongoing safety monitoring remains a determinant of the drug’s market trajectory.

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Competitive Landscape and Product Portfolio

OMNIPAQUE 180 faces competition primarily from other iohexol-based contrast agents and alternative imaging options. Key competitors include products like GE’s VISIPAQUE, and non-iodinated contrast agents, including MRI-based alternatives. The differentiation strategies hinge on factors such as:

• Efficacy and Safety Profiles: OMNIPAQUE’s high-quality imaging with minimal adverse events sustains its preferential status.
• Pricing Strategies: Competitive pricing influences market share, especially in price-sensitive markets.
• Brand Recognition and Physician Preference: Strong brand recognition owing to GE Healthcare’s extensive distribution network fortifies its market position.

The development of newer contrast agents with reduced side effects, improved bioavailability, or enhanced imaging capabilities presents an ongoing challenge to OMNIPAQUE’s dominance.

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Technological Advancements and Usage Trends

Advancements in imaging technology, including higher-resolution CT scans and hybrid modalities like PET-CT, influence contrast agent requirements. The shift towards personalized medicine necessitates contrast agents tailored for specific patient groups, such as those with renal impairments or allergies.

In addition, the trend toward lower-volume and non-iodinated contrast agents aims to improve patient safety. While these innovations might reduce reliance on traditional agents like OMNIPAQUE 180 for certain indications, they also open opportunities for product innovation and differentiation.

The COVID-19 pandemic catalyzed a surge in diagnostic imaging, temporarily boosting demand for contrast agents including OMNIPAQUE. As healthcare services rebound, maintaining competitive volume growth depends on adoption in emerging regions and adaptation to changing clinical protocols.

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Market Drivers and Restraints

Drivers:

• Growing global imaging needs: Rising prevalence of chronic diseases, cancer, and cerebrovascular disorders increase demand.
• Aging population: Older adults require more diagnostic procedures involving contrast-enhanced imaging.
• Technological innovations: Improved imaging facilitates expanded use of contrast agents.
• Expanding healthcare infrastructure: Particularly in Asia-Pacific and Latin America, boosts access and utilization.

Restraints:

• Safety concerns: Contrast-induced nephropathy remains a contraindication, prompting cautious use.
• Regulatory restrictions: Post-marketing safety mandates can limit peak utilization.
• Emerging imaging modalities: MRI and ultrasound using non-iodinated contrast agents threaten to displace CT contrast agents.

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Financial Trajectory and Market Revenue Projections

Historically, OMNIPAQUE 180 has demonstrated a stable revenue stream within the diagnostic imaging segment of GE Healthcare’s broader portfolio. In 2022, the contrast agent segment accounted for approximately 15-20% of GE Healthcare’s diagnostic revenues, reflecting strong market penetration.

Global revenue estimates for the contrast agent segment are projected to grow at a compound annual growth rate (CAGR) of 4-6% over the next five years [1]. This growth is driven by increasing imaging procedures, particularly in emerging markets where healthcare infrastructure investments are accelerating. However, innovation in alternative modalities and safety modifications may constrain growth potential.

Estimations suggest that OMNIPAQUE’s sales could see moderate expansion if it maintains regulatory compliance, expands into untapped regions, and leverages technological innovations to address safety and efficacy concerns. Conversely, a decline could occur if innovative contrast alternatives gain widespread acceptance, or if regulatory hurdles intensify.

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Key Market Opportunities and Strategic Considerations

To capitalize on growth opportunities, GE Healthcare is investing in new formulations and optimizing supply chains. Emphasis on targeted marketing efforts, clinician education, and reimbursement negotiations are crucial strategies. Furthermore, diversifying the product portfolio to include formulations with lower osmolality and better safety profiles could mitigate market risks.

Partnerships with hospitals, imaging centers, and radiology societies enhance product adoption. Entering emerging markets through strategic alliances and local manufacturing can significantly augment revenue streams.

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Impact of Regulatory and Global Economic Factors

Changing healthcare policies, reimbursement models, and economic conditions will continue to influence the financial trajectory of OMNIPAQUE 180. For example, value-based care initiatives emphasize cost-effectiveness and safety, likely encouraging adoption of newer, safer contrast agents over traditional ones. Economic downturns may also constrain healthcare spending, affecting procurement volumes.

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Conclusion

OMNIPAQUE 180’s market dynamics are shaped by a confluence of regulatory, competitive, technological, and demographic factors. While its position as a reliable contrast agent supports steady demand, ongoing innovations and safety considerations present both challenges and opportunities. The financial outlook remains cautiously optimistic, contingent on product differentiation, regional market expansion, and adaptation to evolving clinical practices.

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Key Takeaways

• Stable Market Position: OMNIPAQUE 180 maintains a strong presence in diagnostic imaging due to efficacy and brand recognition but must innovate to sustain leadership.
• Growth Potential: The global imaging market, particularly in emerging economies, offers growth opportunities driven by increasing disease burdens and healthcare infrastructure investments.
• Challenges: Safety concerns, regulatory restrictions, and competition from advanced contrast agents and non-iodinated alternatives threaten future revenue streams.
• Strategic Focus: Innovation in formulation, geographic expansion, and strengthening provider relationships are critical for optimizing financial trajectory.
• Regulatory and Economic Ecosystem: Adaptability to changing healthcare policies and economic conditions will significantly influence the long-term profitability of OMNIPAQUE 180.

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FAQs

1. What factors influence the demand for OMNIPAQUE 180 globally?
   Rising prevalence of chronic and vascular diseases, aging populations, technological advancements in imaging, and expansion of healthcare infrastructure in emerging markets primarily drive demand.

2. How does safety profile impact OMNIPAQUE 180’s market share?
   Concerns over contrast-induced nephropathy and allergic reactions influence prescribing practices, with safety improvements and regulatory guidelines shaping usage patterns.

3. What are the main competitive threats to OMNIPAQUE 180?
   Alternatives include other iodinated contrast agents with enhanced safety, advances in MRI contrast agents, and non-iodinated imaging modalities such as ultrasound and PET-CT.

4. How might regulatory changes affect OMNIPAQUE 180’s sales?
   Stricter safety regulations and restrictions on contrast volume or indications can limit market access and usage, while supportive policies can facilitate growth.

5. What strategies can GE Healthcare pursue to sustain OMNIPAQUE 180’s market relevance?
   Focus on developing safer, lower-volume formulations, expanding geographically, engaging in clinician education, and aligning with payment and reimbursement policies.

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Sources:

[1] Market research insights and projections based on industry reports and GE Healthcare’s recent financial disclosures.