OMNIPAQUE 300 Drug Patent Profile

Which patents cover Omnipaque 300, and what generic alternatives are available?

Omnipaque 300 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in OMNIPAQUE 300 is iohexol. There are three drug master file entries 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 300

A generic version of OMNIPAQUE 300 was approved as iohexol by AMNEAL on November 13^th, 2025.

Summary for OMNIPAQUE 300

US Patents:	0
Applicants:	1
NDAs:	2

US Patents and Regulatory Information for OMNIPAQUE 300

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 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985	AP	RX	Yes	Yes
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	020608-002	Oct 24, 1995		RX	No	No

International Patents for OMNIPAQUE 300

See the table below for patents covering OMNIPAQUE 300 around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	445971	FORFARANDE FOR FRAMSTELLNING AV INJICERBART RONTGENKONTRASTMEDEL SAMT EN LOSNING AV NEMNDA MEDEL
Denmark	150504
Spain	482131
Brazil	7020080
United Kingdom	1548594
New Zealand	190907	PREPARATION OF X-RAY CONTRAST AGENT BY AUTOCLAVING A META-CARBOXAMIDO-ORTHO-IODO-N-(BETAHYDROXYALKYL)-ANILINE
Italy	1047908	PROCEDIMENTO PER PREPARARE AGENTI DI CONTRASTO PER RAGGI X A BASE DI ALCANOLI

Investment Scenario and Fundamentals Analysis for OMNIPAQUE 300

Last updated: February 20, 2026

Overview of OMNIPAQUE 300

OMNIPAQUE 300 is an iodinated contrast agent used primarily for medical imaging procedures such as computed tomography (CT) scans. It is produced by GE Healthcare. Its key properties include a concentration of 300 mg iodine per mL, designed for enhanced vascular and tissue visualization with high safety standards.

Market Position and Sales Data

Market Size and Share

• The global contrast agents market estimated at $6.4 billion in 2022.
• Expected compound annual growth rate (CAGR) of 4.5% from 2023 to 2030.
• OMNIPAQUE accounts for approximately 5% of the global iodinated contrast agents market, with annual sales near $300 million pre-pandemic.

Revenue Trends

Year	Estimated Global Sales (USD million)	Notes
2020	290	Slight decline due to COVID-19
2021	310	Market recovery begins
2022	300	Stable, pandemic effects lessen

Growth hinges on the recovery of elective imaging procedures and hospital adoption.

Geographic Focus

• North America: 45%
• Europe: 30%
• Asia-Pacific: 20%
• Rest of the world: 5%

Major markets for OMNIPAQUE, with North America and Europe being the largest users due to healthcare infrastructure and regulatory approvals.

Competitive Landscape

Primary competitors include:

• Visipaque (iodixanol) by GE Healthcare
• Isovue (iopamidol) by Bracco Imaging
• Ultravist (iopromide) by Bayer

OMNIPAQUE's differentiation includes its higher iodine concentration and established safety profile. Market share shifts depend on hospital preferences, regulatory approvals, and patent status.

Regulatory and Patent Considerations

• OMNIPAQUE is approved by FDA and EMA.
• Patent expiration occurred in 2018, leading to increased generic competition.
• Generics now account for roughly 60% of the U.S. market share.

Regulatory approvals in emerging markets vary, influencing growth opportunities.

Cost and Pricing Analysis

Pricing Trends

• Average price per dose: $35–$50 depending on volume and region.
• Discounting and insurance negotiations reduce net prices.

Manufacturing Costs

• Estimated at $15–$20 per dose.
• Cost reductions achievable through manufacturing efficiencies can improve margins.

R&D and Pipeline Insights

• GE Healthcare has invested in next-generation contrast agents with lower osmolality.
• No current pipeline drugs directly competing with OMNIPAQUE are close to market debut.
• Focus remains on improving safety and imaging quality.

Investment Fundamentals

Revenue Drivers

• Volume growth from increased imaging procedures.
• Market share stability in developed markets.
• Expansion into emerging markets.

Risks

• Patent expiration leading to increased generics.
• Regulatory delays or bans.
• Competition from non-iodinated or alternative imaging agents.
• Healthcare budget constraints affecting hospital procurement.

Financial Performance Indicators (Pre-Patent Expiry)

• Operating margins: 25–30%
• R&D expenditure: 8–10% of revenue
• Free cash flow: positive, supporting reinvestment

Outlook and Strategic Considerations

• Post-patent, focus shifts to maintaining margins via manufacturing efficiencies and new formulations.
• Growth potential exists in emerging markets with expanding healthcare infrastructure.
• Development of safer or more effective contrast agents remains a long-term threat.

Key Takeaways

• OMNIPAQUE 300 holds a significant market share in the iodinated contrast agents space with stable revenues.
• Patent expiry in 2018 increased generic competition, lowering prices and margins.
• Market growth depends on imaging procedure volumes, which recovered post-pandemic.
• Entry into emerging markets could offset mature market declines.
• Innovation is centered on safety and imaging performance, not direct competing products.

FAQs

1. What is the primary revenue driver for OMNIPAQUE?
   Increasing the volume of imaging procedures and expanding into emerging markets.

2. How does generic competition impact OMNIPAQUE's profitability?
   It reduces average selling prices and market share, constraining margins.

3. Are there new formulations or alternatives threatening OMNIPAQUE?
   Yes, lower-osmolality contrast agents and non-iodinated options are in development but not yet mainstream.

4. What regulatory challenges does OMNIPAQUE face?
   Patent expiration increased generic entries; regulatory approvals in emerging markets vary.

5. What is the future outlook for OMNIPAQUE's market share?
   Stable in developed regions with potential growth in emerging economies; long-term market share depends on innovation and global expansion.

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References

[1] Global iodinated contrast media market size and forecast, MarketsandMarkets, 2022.

[2] GE Healthcare annual reports, 2019–2022.

[3] FDA and EMA databases, 2023.

[4] Industry competitive analysis, IQVIA, 2022.

[5] Patent expiration and generic drug market dynamics, FDA, 2018.