OMNIPAQUE 300 Drug Patent Profile

When do Omnipaque 300 patents expire, and when can generic versions of Omnipaque 300 launch?

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. Three 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
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	26
Patent Applications:	4,191
DailyMed Link:	OMNIPAQUE 300 at DailyMed

Recent Clinical Trials for OMNIPAQUE 300

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 300 clinical trials

Pharmacology for OMNIPAQUE 300

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

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

Expired US Patents for OMNIPAQUE 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985

International Patents for OMNIPAQUE 300

See the table below for patents covering OMNIPAQUE 300 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

Market Dynamics and Financial Trajectory for OMNIPAQUE 300

Last updated: February 14, 2026

Market Overview

OMNIPAQUE 300, developed by GE Healthcare, is a contrast agent used in diagnostic imaging, specifically for computed tomography (CT) scans. Its primary function is to enhance image clarity of blood vessels and tissues. The global contrast media market, valued at $6.5 billion in 2022, is expected to grow at a compound annual growth rate (CAGR) of approximately 4% through 2027, driven by increasing demand for advanced diagnostic imaging and expanding healthcare infrastructure in emerging markets[1].

Competitive Landscape

OMNIPAQUE faces competition from other iodine-based contrast agents, such as Bracco’s Visipaque and Bayer’s Ultravist. Market share is influenced by factors including brand recognition, safety profiles, pricing strategies, and regulatory approvals. OMNIPAQUE’s established presence in hospitals and diagnostics centers provides competitive advantages, but recent patent expirations and generic entries could pressure margins.

Regulatory and Patent Status

• Regulatory Approvals: OMNIPAQUE is approved in multiple regions including the U.S., Europe, and Asia. The FDA approval dates back to 1994, with ongoing renewals and supplemental approvals for new indications.
• Patent Status: The key patent protecting OMNIPAQUE expired in 2016 in the U.S. and Europe, leading to increased generic competition. Despite this, brand loyalty and clinical familiarity sustain current pricing levels.

Revenue and Sales Trends

• Historical Data: GE Healthcare reported global sales of contrast agents including OMNIPAQUE at approximately $800 million in 2021, representing around 12% of their diagnostic imaging segment.
• Forecast: After patent expiration, revenue growth slowed. Yet, an estimated 3-4% annual growth in emerging markets compensates for stagnation in mature markets.

Pricing and Reimbursement

Pricing dynamics vary globally:

• U.S.: Reimbursement depends on Medicare and insurance policies, with contrast media typically reimbursed at $50-$150 per dose.
• Europe: Price regulations result in lower per-unit costs, approximately €40-€100.
• Emerging Markets: Lower pricing — about 50% of developed market levels — but higher volume sales offset lower unit revenue.

Market Risks and Opportunities

• Risks: Expiration of key patents, commoditization, and substitution with newer imaging modalities (e.g., MRI contrast agents, non-contrast imaging) threaten market share.
• Opportunities: Expansion into emerging markets, development of pre-filled syringes, and new indications in pediatric and cardiovascular imaging could drive future sales.

Financial Trajectory

• Short Term (1-2 years): Revenue growth stabilizes around 2-3%, driven by emerging markets and new hospital uptake.
• Medium to Long Term (3-5 years): Gradual decline in mature markets as generic competition intensifies. Revenue from emerging markets and innovation investments may sustain overall growth at 1-2% annually.
• Sales Channels: Predominantly hospital procurement, with growth potential in outpatient imaging centers.

Strategic Outlook

GE Healthcare’s strategy involves optimizing manufacturing efficiencies, expanding into new geographic regions, and developing next-generation contrast agents with improved safety profiles. They are also investing in competitive bidding processes and digital health integrations to improve cost-efficiency.

---

Key Takeaways

• OMNIPAQUE 300 faces sustained but declining revenues due to patent expiration and increasing generic competition.
• Market growth is supported by rising diagnostic imaging demand especially in emerging economies.
• Price pressures are tempered by reimbursement policies and regional pricing differences.
• Innovation and geographic expansion are primary avenues for revenue stabilization.
• Long-term prospects hinge on product differentiation and shifts to alternative imaging modalities.

---

FAQs

1. How has patent expiration affected OMNIPAQUE’s market share?
Patent expiration in 2016 led to increased generic competition, reducing profit margins but the brand maintains market share through clinical familiarity and distribution channels.

2. What regions offer the highest growth potential for OMNIPAQUE?
Emerging markets such as China, India, and Southeast Asia exhibit high growth potential due to expanding healthcare infrastructure and diagnostic capacity.

3. What challenges does OMNIPAQUE face from technological advancements?
Shift toward MRI contrast agents and non-contrast imaging reduces dependencies on iodine-based agents, potentially shrinking the market.

4. How does pricing vary globally for OMNIPAQUE?
Pricing in developed regions like the U.S. ranges from $50 to $150 per dose, while in Europe it averages €40-€100. Emerging markets see about 50% lower prices.

5. What strategies could extend OMNIPAQUE’s commercial life?
Developing new indications, improving safety profiles, and innovating delivery mechanisms are key strategies.

---

Sources

[1] MarketWatch, "Contrast Media Market Size & Share Analysis," 2022.