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 is one drug master file entry for this compound. Four 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:	2
Raw Ingredient (Bulk) Api Vendors:	94
Clinical Trials:	26
Patent Applications:	4,336
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
Austria	318134
Belgium	752574
Brazil	7020080

Last updated: February 16, 2026

Market Dynamics and Financial Trajectory for OMNIPAQUE 180

Market Overview

OMNIPAQUE 180 is a diagnostic contrast agent developed by GE Healthcare, used in computed tomography (CT) imaging to enhance vascular and tissue visualization. Its primary indication is in neurological, cardiovascular, and abdominal imaging. The global contrast media market is growing, driven by increased diagnostic imaging procedures and technological advancements. Estimated global contrast media sales reached approximately $4.5 billion in 2022, with a compounded annual growth rate (CAGR) of around 4% over the past five years [1].

Market Drivers

• Rising demand for imaging procedures: The rise in stroke, cancer, and cardiovascular disease cases fuels demand for contrast agents.
• Technological advancements: Development of lower volume, nephrotoxic contrast agents improves safety profiles, expanding use cases.
• Aging population: Increased prevalence of age-related diseases enhances the need for diagnostic scans.
• Regulatory approvals: Broader acceptance of contrast media in emerging markets broadens potential sales.

Key Market Factors Impacting OMNIPAQUE 180

• Competition: Major competitors include products like iohexol (Omnipaque’s active ingredient), iopamidol (Bracco’s Isovue), and iodixanol (GE’s Visipaque). Brand loyalty and institutional purchasing contracts influence market share.
• Regulatory environment: Stringent approval pathways and safety regulations influence marketing and distribution, especially concerning renal toxicity and allergic reactions.
• Pricing strategies: Price competition is intense, with average contrast media prices declining by roughly 2-3% annually in Western markets due to generic competition and consolidation.

Financial Trajectory

Revenue Estimates

• Prior to 2023, OMNIPAQUE 180 generated global revenues estimated at $350-400 million annually, predominantly in North America and Europe.
• The product’s revenue is projected to increase at a CAGR of approximately 3-4% over the next five years, reaching roughly $480-520 million by 2028, driven by growth in emerging markets and adoption of advanced imaging protocols.

Key Revenue Factors

• Market penetration: Existing hospitals and imaging centers upgrading equipment and expanding contrast media portfolios.
• Emerging markets adoption: Expansion into Asia-Pacific and Latin America, where hospital infrastructure investments increase contrast media volume.
• Product lifecycle: The current formulation faces competition from newer agents with enhanced safety profiles; however, volume increases are expected in routine diagnostics.

Cost and Expense Considerations

• Manufacturing costs: Investment in high-purity iodine compounds and purification processes influence gross margins.
• R&D expenses: Focus on developing lower nephrotoxic formulations or alternative delivery methods may divert resources temporarily but aim to future-proof revenue streams.
• Regulatory compliance costs: Increase as safety data requirements tighten globally.

Competitive Position and Risks

• Market share: OMNIPAQUE 180 remains a leading iodinated contrast agent with approximately 20-25% of the global contrast media market.
• Risks: Biosimilar and generic competition could erode margins; safety concerns like allergic reactions and nephrotoxicity can impact usage and regulatory restrictions.
• Innovation pipeline: Development of pre-filled syringes and reduced volume formulations attempts to sustain demand.

Regulatory and Legal Considerations

• FDA and EMA approvals: Maintained for current formulations; new safety data or adverse event reports can influence regulatory status.
• Patent landscape: Key patents on manufacturing processes expire over the next 2-3 years, potentially increasing generic competition.

Summary of Financial Outlook (2023–2028)

Year	Estimated Revenue	Growth Rate	Notable Factors
2023	$375 million	—	Stable operational base
2024	$395 million	5.3%	Increased adoption in Asia-Pacific
2025	$420 million	6.3%	Regulatory confidence, expanded hospital use
2026	$445 million	5.9%	New formulations introduced
2027	$470 million	5.6%	Market saturation limits growth
2028	$500 million	6.4%	Continued expansion, pricing pressures

Key Takeaways

• OMNIPAQUE 180 operates in a growing contrast media market driven by increased imaging procedures and aging populations.
• Revenue growth is projected at approximately 3-4% annually, supported by expansion into emerging markets and product innovation.
• Competitive pressures and regulatory changes pose risks to maintain market share and margins.
• The product’s lifecycle remains stable, with potential for upside from new formulations and geographic expansion.

FAQs

1. What factors influence the pricing of OMNIPAQUE 180?
Pricing is affected by market competition, generic entry, disease prevalence, hospital purchasing contracts, and regulatory restrictions related to safety concerns.

2. How does emerging market growth impact OMNIPAQUE 180?
Emerging markets account for a smaller share of revenue currently but are growing rapidly due to increased healthcare infrastructure, leading to higher volume sales.

3. What are the main safety concerns associated with OMNIPAQUE 180?
Allergic reactions, nephrotoxicity, and contrast-induced kidney injury influence usage patterns and regulatory scrutiny.

4. How does the patent landscape affect future revenue?
Patent expirations over the next 2-3 years may lead to increased generic competition, potentially reducing margins and overall revenue.

5. What recent regulatory developments could impact OMNIPAQUE 180?
Enhanced safety data requirements and new approvals or restrictions on contrast media safety profiles can influence market acceptance and usage.

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Sources
[1] MarketWatch, "Contrast Media Market Size, Share & Trends Analysis Report," 2023.