OMNIPAQUE 70 Drug Patent Profile

When do Omnipaque 70 patents expire, and when can generic versions of Omnipaque 70 launch?

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 13^th, 2025.

Summary for OMNIPAQUE 70

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	26
Patent Applications:	4,942
DailyMed Link:	OMNIPAQUE 70 at DailyMed

Recent Clinical Trials for OMNIPAQUE 70

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 70 clinical trials

Pharmacology for OMNIPAQUE 70

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

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

Expired US Patents for OMNIPAQUE 70

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 70	iohexol	SOLUTION;URETHRAL	018956-007	Jun 1, 1994
Ge Healthcare	OMNIPAQUE 70	iohexol	SOLUTION;URETHRAL	018956-007	Jun 1, 1994

International Patents for OMNIPAQUE 70

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

Country	Patent Number	Title	Estimated Expiration
Australia	523295
Germany	2031724
Netherlands	153083
Sweden	7706792
Japan	S6210209
Germany	2926850

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: OMNIPAQUE 70

Last updated: July 28, 2025

---

Introduction

OMNIPAQUE 70, a notable iodinated contrast agent, is extensively utilized in diagnostic imaging procedures such as computed tomography (CT) scans. As a product within the powerful diagnostic imaging segment, its market position hinges on technological advancements, regulatory landscapes, clinical efficacy, and competitive dynamics. This analysis delineates the evolving market environment surrounding OMNIPAQUE 70, projecting its financial trajectory amid shifting industry and healthcare trends.

---

Market Overview

Product Profile and Therapeutic Utility

OMNIPAQUE 70, developed by GE Healthcare, belongs to the diatrizoate meglumine and diatrizoate sodium class of contrast agents. It enhances radiographic images by improving visualization of vascular and soft tissue structures during diagnostic procedures. Its popularity stems from favorable pharmacokinetics, safety profile, and compatibility with a broad spectrum of imaging modalities.

Market Segmentation

The contrast agent market is segmented based on formulation type—ionic versus non-ionic, and administered modality—intravenous, intra-arterial, or oral. OMNIPAQUE 70 caters predominantly to intravenous applications, serving hospitals, diagnostic labs, and imaging centers worldwide.

---

Market Dynamics Influencing OMNIPAQUE 70

1. Growing Demand for Diagnostic Imaging

The global rise in chronic diseases, particularly cardiovascular, neurological, and oncological disorders, fuels demand for diagnostic imaging. CT scans, in which OMNIPAQUE 70 is utilized, remain critical for accurate diagnosis, thereby propelling the contrast agent market. The World Health Organization reports a surge in imaging procedures globally, with annual growth rates averaging 5-7% amid advancements in healthcare infrastructure, especially in emerging economies.

2. Technological Innovations and Competitive Landscape

While Omnipaque enjoys considerable market share, the contrast agent space is competitive, featuring alternatives like iohexol, iopamidol, and iodixanol. Innovations such as lower-osmolar and iso-osmolar contrast media aim to mitigate adverse effects, impacting demand dynamics. Vendors investing in formulation research aim to improve safety profiles and expand indications, thus influencing market positioning.

3. Regulatory Environment and Safety Concerns

Stringent regulatory frameworks governing contrast media safety influence market supply and acceptance. Notable concerns include nephrotoxicity and allergic reactions, prompting a push for safer, nonionic contrast agents. Post-marketing safety data significantly influence clinicians’ preferences, affecting OMNIPAQUE's sales trajectory.

4. Pricing Strategies and Healthcare Policies

Reimbursement policies significantly affect adoption rates. In developed markets, insurance coverage and reimbursement incentives favor the use of high-quality contrast agents like OMNIPAQUE. However, the advent of generics and pricing pressures from healthcare systems in emerging markets pose challenges to profit margins.

5. Impact of COVID-19 Pandemic

The pandemic temporarily disrupted imaging procedures, attenuating contrast agent sales in 2020. Nonetheless, as healthcare systems normalize, a rebound in imaging volumes supports market recovery. Additionally, increased health awareness spurs demand for diagnostic services, indirectly benefiting contrast media sales.

---

Financial Trajectory and Market Forecast

Revenue Trends and Growth Projections

Globally, the contrast media market was valued at approximately USD 4.7 billion in 2022, with an expected compound annual growth rate (CAGR) of around 5% through 2030 [1]. OMNIPAQUE, as a leading brand, is projected to retain a significant share due to established clinical preferences.

Drivers of Revenue Growth

• Expanding Clinical Applications: Development of new indications such as molecular imaging could diversify OMNIPAQUE’s utilization.

• Geographical Expansion: Growth in emerging markets, notably Asia-Pacific, presents lucrative opportunities, as healthcare infrastructure development accelerates.

• Product Differentiation: Continuous improvements in safety and efficacy bolster its market position, promoting premium pricing strategies.

Challenges to Sustained Growth

• Competitive Pressures: Non-ionic, iso-osmolar agents with superior safety profiles threaten market share.

• Regulatory Scrutiny: Stringent safety regulations may prompt reformulation or limited acceptance, dampening growth prospects.

• Cost Containment: Healthcare payers’ emphasis on cost-effective alternatives pressures pricing strategies, especially in price-sensitive markets.

Projected Financial Outlook

Based on industry reports, OMNIPAQUE’s sales are expected to grow at a CAGR of 4-6% over the next five years. This moderate growth aligns with industry trends, with potential accelerations in regions experiencing healthcare investments and technological adoption.

---

Market Entry and Strategic Considerations

• Product Differentiation: Focus on developing formulations with improved safety and reduced adverse effects.

• Partnerships: Collaborating with regional distribution channels can accelerate penetration in emerging markets.

• Regulatory Navigation: Keeping pace with evolving safety standards ensures market access and minimizes disruptions.

• Value-Added Services: Providing clinical support and training enhances brand loyalty among healthcare providers.

---

Key Market Drivers and Restraints

Drivers	Restraints
Rising diagnostic imaging demand across healthcare sectors	Safety concerns regarding nephrotoxicity and allergic reactions
Technological advances in imaging modalities	Competition from newer, safer contrast media
Growing healthcare expenditures in emerging markets	Pricing pressures and generic competition
Adoption of minimally invasive diagnostic procedures	Regulatory limitations and safety regulations

---

Conclusion

The market environment for OMNIPAQUE 70 remains resilient amid challenges, driven by the expanding global demand for diagnostic imaging. The product’s financial trajectory is poised for steady growth, predicated on innovation, strategic market expansion, and safety profile enhancements. However, competitors’ technological advancements and regulatory pressures necessitate ongoing adaptation to sustain market positioning and profitability.

---

Key Takeaways

• Steady Growth Opportunity: The contrast media segment, and by extension OMNIPAQUE 70, is expected to grow annually around 4-6%, driven by increased imaging procedures worldwide.

• Competitive Landscape: Innovations toward safer contrast agents and emerging competition require continuous product differentiation.

• Regional Expansion: Developing markets in Asia-Pacific present substantial growth prospects, supported by healthcare infrastructure investments.

• Regulatory Vigilance: Maintaining compliance with safety standards is critical to sustain market access and consumer confidence.

• Strategic Focus: Emphasizing safety, efficacy, and regional collaborations will optimize revenue streams in a competitive environment.

---

FAQs

1. How does OMNIPAQUE 70 differentiate itself in the contrast media market?
OMNIPAQUE 70 is known for its high visibility during imaging, favorable safety profile, and compatibility with various diagnostic procedures, which sustain its competitive edge in clinical settings.

2. What are the key safety concerns associated with iodinated contrast agents like OMNIPAQUE?
Nephrotoxicity and allergic reactions are primary safety concerns. Advancements focusing on osmolarity reduction aim to minimize these adverse effects.

3. How do regulatory changes impact OMNIPAQUE’s market performance?
Stringent regulations for safety monitoring and labeling influence product formulations and marketing strategies, potentially affecting sales and distribution.

4. What factors are fueling the expansion of contrast media in emerging markets?
Rising healthcare expenditure, growing imaging procedures, and technological adoption underpin expanding demand in regions such as Asia-Pacific.

5. What strategic actions should stakeholders consider to maintain OMNIPAQUE’s market position?
Focusing on innovation, regional partnerships, safety enhancements, and competitive pricing are essential for sustaining growth amid industry competitors.

---

References

[1] MarketsandMarkets. "Contrast Media Market by Product, Application, and Region – Global Forecast to 2030," 2022.