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
Fédération des médecins résidents du Québec	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
Sweden	441181	NYA NONJONOGENA, JODHALTIGA FORENINGAR FOR ANVENDNING SOM RONTGENKONTRASTMEDEL
Italy	1047908	PROCEDIMENTO PER PREPARARE AGENTI DI CONTRASTO PER RAGGI X A BASE DI ALCANOLI
Austria	371998
South Africa	7903313
Ireland	34927	NON-IONIC IODINATED X-RAY CONTRAST AGENTS

Market Dynamics and Financial Trajectory for OMNIPAQUE 70

Last updated: February 20, 2026

OMNIPAQUE 70 (iodixanol injection) is an iodinated contrast agent used in diagnostic imaging procedures, particularly computed tomography (CT). The product's inclusion in the contrast media market influences its revenue, adoption rates, and competitive positioning.

Market Size and Growth Drivers

The global contrast media market was valued at approximately USD 4.8 billion in 2021 and is projected to reach USD 7.5 billion by 2028, growing at a compound annual growth rate (CAGR) of around 6.2% (Grand View Research, 2022[1]). Iodixanol (OMNIPAQUE) accounts for a significant share, driven by its efficacy and safety profile.

Key growth drivers include:

• Increase in diagnostic imaging procedures, especially CT scans.
• Growing healthcare infrastructure in emerging markets.
• Rising prevalence of cardiovascular and oncological conditions demanding advanced imaging.

Competitive Landscape

OMNIPAQUE 70 competes primarily with iohexol (e.g., Omnipaque), iopamidol, and other iodinated contrast agents. Its differentiation stems from:

• Equal or superior image clarity.
• Lower incidence of adverse reactions, especially in patients with renal impairments.

Major manufacturers include GE Healthcare (distributor of Omnipaque), Guerbet, and Bayer (for other contrast agents). OMNIPAQUE remains common in hospitals but faces competition from low-osmolar and iso-osmolar alternatives.

Regulatory and Pricing Environment

Regulatory approvals are stable across North America, Europe, and several Asia-Pacific countries. Pricing varies geographically:

• In the U.S., contrast media typically range from USD 10 to USD 30 per dose.
• Emerging markets tend toward lower prices, impacting margins.

Reimbursement policies influence usage rates; in the U.S., CMS reimbursement for contrast media affects hospital procurement decisions.

Revenue and Financial Trends

While exact sales figures for OMNIPAQUE 70 are proprietary, estimates suggest:

• The contrast media segment generates approximately USD 3 billion annually globally.
• OMNIPAQUE accounts for roughly 20-25% of the iodinated contrast media market.

Assuming a stable market share and growth aligned with overall market expansion, revenue trajectories for OMNIPAQUE are:

Year	Estimated Market Share	Projected Revenue (USD Million)
2021	20%	600
2024	20-22%	750-825
2028	22-25%	900-1,000

These figures presume consistent demand growth, controlled pricing strategies, and no disruptive regulatory changes.

Innovation and Future Outlook

Current research explores formulations with improved safety profiles, such as lower osmolality agents, but OMNIPAQUE's iso-osmolar profile remains competitive. It is uncertain how new contrast media targeting specific imaging modalities may impact OMNIPAQUE’s market share.

Risks and Challenges

• Market saturation in developed regions.
• Regulatory restrictions due to iodinated contrast media-associated risks, like contrast-induced nephropathy.
• Transition to alternative imaging technologies, reducing dependence on contrast agents.

Key Financial Considerations

• Revenue growth hinges on increasing procedure volumes rather than price hikes.
• Margins may compress due to competitive pricing pressures.
• Strategic partnerships with healthcare providers and value-based care initiatives support sales stability.

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Key Takeaways

• The global contrast media market is expanding at 6.2% CAGR, projected to reach USD 7.5 billion by 2028.
• OMNIPAQUE 70 holds an estimated 20-25% market share within iodinated contrast agents.
• Revenue estimates for OMNIPAQUE suggest USD 600 million in 2021, rising to approximately USD 900 million to USD 1 billion by 2028.
• Competitive pressures, regulatory environment, and procedural volume growth directly influence financial performance.
• Innovations favoring safety and compatibility with advancing imaging modalities may alter market dynamics.

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FAQs

1. How does OMNIPAQUE differ from other contrast agents?
OMNIPAQUE features an iso-osmolar profile, reducing adverse reactions compared to low-osmolar alternatives. It provides clear imaging with a lower risk of contrast-induced nephropathy, especially in vulnerable patients.

2. What factors could impact the future revenue of OMNIPAQUE?
Market saturation, regulatory restrictions, rapid adoption of non-iodinated contrast agents, and technological shifts in imaging modalities.

3. How is pricing varied geographically?
Pricing ranges from USD 10 to USD 30 per dose in North America, with lower prices in emerging markets. Reimbursement rates influence hospital procurement.

4. What are the main competitors of OMNIPAQUE?
Iohexol (Omnipaque), iopamidol, and other low-osmolar or iso-osmolar contrast agents from Guerbet and Bayer.

5. What role do regulatory changes play in OMNIPAQUE's market trajectory?
Regulations on iodinated contrast agents due to nephropathy concerns can restrict usage, influence product formulations, or accelerate adoption of alternative agents.

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References

[1] Grand View Research. (2022). Contrast Media Market Size, Share & Trends Analysis Report.