OMNIPAQUE 140 Drug Patent Profile

When do Omnipaque 140 patents expire, and when can generic versions of Omnipaque 140 launch?

Omnipaque 140 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 140 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 140

A generic version of OMNIPAQUE 140 was approved as iohexol by AMNEAL on November 13^th, 2025.

Summary for OMNIPAQUE 140

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	26
Patent Applications:	4,620
DailyMed Link:	OMNIPAQUE 140 at DailyMed

Recent Clinical Trials for OMNIPAQUE 140

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

Sponsor	Phase
Breakthrough T1D	PHASE2
University of California, San Diego	PHASE2
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	Phase 4

See all OMNIPAQUE 140 clinical trials

Pharmacology for OMNIPAQUE 140

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

US Patents and Regulatory Information for OMNIPAQUE 140

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 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988		RX	Yes	Yes

Expired US Patents for OMNIPAQUE 140

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988

International Patents for OMNIPAQUE 140

See the table below for patents covering OMNIPAQUE 140 around the world.

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

Market Dynamics and Financial Trajectory for OMNIPAQUE 140

Last updated: July 28, 2025

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Introduction

OMNIPAQUE 140, a contrast agent primarily composed of iohexol, serves as an essential imaging adjunct in diagnostic radiology, notably for computed tomography (CT) scans. Since its approval, OMNIPAQUE 140 has cemented its position within the contrast media segment of the pharmaceutical industry. This analysis explores the evolving market landscape, competitive forces, revenue trends, and future growth prospects of OMNIPAQUE 140, providing insights vital for stakeholders and investors.

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Market Landscape and Key Drivers

Global Demand for Diagnostic Imaging

The rising prevalence of chronic diseases, including cancer, cardiovascular, and neurological disorders, underpins increased diagnostic imaging rates worldwide. As healthcare infrastructure broadens, particularly in emerging markets, the demand for contrast agents like OMNIPAQUE 140 surges. According to a report by MarketsandMarkets, the global diagnostic imaging market is projected to reach $36.2 billion by 2026, growing at a CAGR of approximately 5.2% from 2021 to 2026[1].

Advantages of Iohexol (OMNIPAQUE 140)

OMNIPAQUE 140’s favorable safety profile, high diagnostic efficacy, and compatibility across a broad patient demographic boost its market adoption. Its lower osmolality compared to earlier contrast agents reduces adverse reactions, further positioning it as a preferred choice among clinicians.

Regulatory and Market Approvals

Approval by the FDA, EMA, and other regulatory agencies has facilitated its global distribution. The continuous expansion into emerging markets through local partnerships and governments' health initiatives has substantially broadened its reach.

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Competitive Landscape

Key Competitors

OMNIPAQUE 140 competes with other iohexol-based contrast agents such as GE Healthcare’s Omnipaque 240 and depending on market segment, iohexol formulations with varying iodine concentrations. Additionally, alternative contrast media like iodixanol (e.g., Visipaque) and gadolinium-based agents also influence the competitive environment.

Market Share Dynamics

Market penetration is influenced by factors such as cost, safety profile, regulatory approvals, and clinician preferences. The positioning of OMNIPAQUE 140 as a cost-effective and reliable contrast agent supports its sustained share within the generic iohexol segment.

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Financial Trajectory and Revenue Trends

Historical Performance

Though exact revenue figures for OMNIPAQUE 140 are often consolidated within parent companies like GE Healthcare (now part of Danaher Corporation), trends indicate steady growth aligned with global imaging market expansion. Pre-pandemic, contrast media revenues grew approximately 4-6% annually, driven by increasing imaging procedures[2].

Impact of COVID-19 Pandemic

The COVID-19 pandemic temporarily suppressed elective imaging procedures, causing a decline in contrast media demand. However, as healthcare services normalize, a rapid rebound is expected, supported by pent-up diagnostic needs and increased screening for chronic illnesses.

Growth Outlook

Projections suggest a compound annual growth rate (CAGR) of 4-5% for the contrast media market through 2026, with OMNIPAQUE 140 benefiting from this trend. Factors such as technological innovations, expanded indications, and growing awareness further support revenue growth.

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Market Dynamics Influencing Future Trajectory

Technological Innovations

Advancements such as low-osmolar and iso-osmolar contrast agents deliver safer, more effective imaging solutions. OMNIPAQUE 140 may see market share gains through formulation improvements or combination with digital health platforms for image enhancement.

Regulatory Trends

Stringent safety regulations and push toward reduced adverse event profiles provide both challenges and opportunities. Companies investing in safer formulations or alternative delivery methods could shift market dynamics.

Healthcare Policy and Reimbursement

Increased reimbursement for diagnostic procedures in developed economies incentivizes institutional adoption. Conversely, cost containment efforts in healthcare systems may pressure pricing strategies.

Emerging Markets

Expansion into Asia-Pacific, Latin America, and Africa presents significant growth opportunities. With expanding healthcare infrastructure, these regions could contribute to double-digit growth segments for contrast media.

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Risks and Challenges

• Price Competition: The availability of generic iohexol formulations exerts downward pressure on prices.
• Regulatory Changes: Post-market safety concerns or regulatory restrictions could impede sales.
• Technological Shifts: Development of new imaging modalities or contrast agents may alter demand patterns.
• Environmental and Safety Concerns: Rising scrutiny over contrast media-related nephropathy and gadolinium deposition could influence clinical practices.

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Conclusion and Future Outlook

OMNIPAQUE 140’s market prospects hinge on sustained demand for diagnostic imaging, technological innovations, and strategic positioning within the iohexol contrast agent segment. As the global healthcare landscape shifts toward precision medicine and minimally invasive diagnostics, the role of contrast media like OMNIPAQUE 140 remains pivotal. Financially, the contrast media segment's steady growth trajectory, with an anticipated CAGR of approximately 4-5% through 2026, underscores its resilience.

In aggregate, the continued penetration into emerging markets, alongside ongoing product optimization and adherence to evolving safety standards, will shape OMNIPAQUE 140’s financial trajectory. Stakeholders should monitor regulatory developments, competitive moves, and technological advancements to harness opportunities and mitigate risks.

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Key Takeaways

• The global diagnostic imaging market is expanding, driven by rising chronic disease prevalence and healthcare infrastructure development, benefiting contrast agents like OMNIPAQUE 140.
• OMNIPAQUE 140's safety profile, cost-effectiveness, and regulatory approvals have sustained its competitive edge.
• Revenue growth is expected to align with overall contrast media market trends, with a CAGR of 4-5% through 2026.
• Emerging markets represent substantial growth opportunities, especially as healthcare access broadens.
• Innovations, regulatory shifts, and technological advances will influence future market dynamics and financial performance.

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FAQs

Q1: How does OMNIPAQUE 140 compare to other contrast agents in terms of safety?

A1: OMNIPAQUE 140, containing iohexol, has a low-osmolality profile, reducing adverse reactions relative to high-osmolar contrast agents. Its safety profile is well-established, with minimal risk of nephrotoxicity compared to older agents, though individual patient factors remain critical.

Q2: What are the primary growth markets for OMNIPAQUE 140?

A2: Developed regions like North America and Europe remain core markets, but rapidly expanding healthcare infrastructure in Asia-Pacific, Latin America, and the Middle East offer significant growth opportunities.

Q3: How might regulatory changes impact OMNIPAQUE 140?

A3: Stricter safety regulations could necessitate formulation modifications or additional safety testing, potentially affecting market access and pricing. Conversely, positive regulatory recognition can enhance market confidence and adoption.

Q4: What competitive strategies could reinforce OMNIPAQUE 140’s market position?

A4: Differentiation through safety, efficacy, cost competitiveness, and expanding indications can reinforce market position. Strategic partnerships and targeted marketing in emerging markets are also vital.

Q5: Will technological innovations threaten OMNIPAQUE 140’s market share?

A5: Yes; emerging imaging modalities, new contrast agents, or alternative diagnostic tools could shift demand away from traditional contrast media. Staying at the forefront of formulation improvements and safety is essential to maintain relevance.

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References

[1] MarketsandMarkets. "Diagnostic Imaging Market by Modality, Application, and Region – Global Forecast to 2026." 2021.

[2] EvaluatePharma. "Contrast Media Market Data & Trends." 2021.

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Disclaimer: This analysis is for informational purposes only and reflects the current market situation, which is subject to change based on technological, regulatory, and economic factors.