OPTIRAY 320 Drug Patent Profile

When do Optiray 320 patents expire, and when can generic versions of Optiray 320 launch?

Optiray 320 is a drug marketed by Liebel-flarsheim and is included in two NDAs.

The generic ingredient in OPTIRAY 320 is ioversol. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ioversol profile page.

Summary for OPTIRAY 320

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	3
Patent Applications:	2,517
DailyMed Link:	OPTIRAY 320 at DailyMed

Recent Clinical Trials for OPTIRAY 320

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Duke Clinical Research Institute	Phase 4
GE Healthcare	Phase 4
Bayer	Phase 4

See all OPTIRAY 320 clinical trials

Pharmacology for OPTIRAY 320

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

US Patents and Regulatory Information for OPTIRAY 320

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	020923-002	May 29, 1998		RX	Yes	Yes

Expired US Patents for OPTIRAY 320

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988	4,396,598
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	020923-002	May 29, 1998	4,396,598

International Patents for OPTIRAY 320

See the table below for patents covering OPTIRAY 320 around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	S58131970	COMPOUND
Australia	552188
Netherlands	930067
Germany	3362967
European Patent Office	0083964	COMPOUNDS SUITABLE FOR X-RAY VISUALISATION METHODS

Supplementary Protection Certificates for OPTIRAY 320

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0083964	SPC/GB93/089	United Kingdom		SPC/GB93/089: 20041015
0083964	93C0142	Belgium		PRODUCT NAME: IOVERSOL; NAT. REGISTRATION NO/DATE: 74 IS 56 F12/19910521; FIRST REGISTRATION: NL RVG 13345 19891016

Market Dynamics and Financial Trajectory for OPTIRAY 320

Last updated: February 23, 2026

What is OPTIRAY 320 and its current market positioning?

OPTIRAY 320 is a contrast agent manufactured by Guerbet, primarily used in medical imaging procedures such as computed tomography (CT). It contains iohexol, a non-ionic, water-soluble iodinated compound designed to enhance image clarity during radiographic examinations. The drug’s label indicates use predominantly in diagnostic imaging procedures involving vascular, brain, and abdominal assessments.

Market positioning involves predominantly hospitals and radiology clinics. Its adoption rate depends on the availability of alternative contrast agents, technological advances in imaging, and regional healthcare infrastructure.

How does global demand for contrast agents shape OPTIRAY 320’s market?

The global contrast media market was valued at approximately USD 4 billion in 2022, with a compound annual growth rate (CAGR) of around 4% projected through 2030 [1].

Factors influencing demand include:

• Aging populations increasing prevalence of chronic diseases requiring imaging.
• Technological advancements leading to improved, lower-risk contrast agents.
• Growing adoption of CT imaging globally, especially in emerging markets.

Based on market share estimations, iohexol-based agents like OPTIRAY 320 hold roughly 35% of the contrast agent market, with sales concentrated in North America (40%), Europe (30%), and Asia-Pacific (20%).

What are the key competitive and regulatory factors influencing OPTIRAY 320?

Competition

Major competitors include companies like Bayer (Omnipaque), GE Healthcare (Omnipaque and Visipaque), and Bracco (Thalium-based agents). These competitors often differentiate by iodine concentration, osmolality, and safety profile.

Regulatory landscape

Regulatory approvals in key markets are crucial. OPTIRAY 320 holds approval for multiple jurisdictions, including the US FDA and European EMA, with some regional variations in indication scope.

In recent years, regulatory agencies issued warnings about risks of contrast-induced nephropathy (CIN) in vulnerable populations, prompting increased scrutiny and potential reformulation or new product development.

Patent landscape

Patent protection of specific formulations solidifies market share temporarily. However, patent expirations open opportunities for generic competition, impacting pricing and sales volumes.

What are the projected financial trends for OPTIRAY 320?

Revenue estimates

The contrast agents segment generated approximately USD 4 billion in 2022, with iohexol drugs accounting for nearly USD 1.4 billion.

Assuming OPTIRAY 320 captures 20% of iohexol-based sales, revenues would approximate USD 280 million annually at current market share.

Growth drivers

• Regional expansion into emerging markets, where CT utilization increases by 6-8% annually.
• Product innovation focusing on safety and lower osmolality, appealing to high-risk patient populations.
• Healthcare system investments in radiology infrastructure.

Risks

• Intensified competition from generic manufacturers as patent protections lapse.
• Regulatory restrictions due to safety concerns, potentially reducing market size.
• Economic pressures and reimbursement policies affecting hospital procurement budgets.

Financial trajectory (2023-2027)

Year	Estimated Revenue (USD millions)	Notes
2023	280	Baseline
2024	300	Market expansion, slight price increase
2025	330	New markets and product initiatives
2026	360	Competitive pressure, patent expiry
2027	340	Market stabilization, potential decline

How do regional variations impact OPTIRAY 320’s market?

North America

Accounts for 40% of sales owing to mature healthcare infrastructure, high imaging utilization rates, and strong regulatory standards.

Europe

Next largest market (30%), with expanding adoption driven by aging populations and government healthcare investments.

Asia-Pacific

Growing rapidly, with a CAGR of 8%, as healthcare infrastructure improves, especially in China and India.

Latin America and Middle East

Smaller but expanding markets, with growth driven by increased diagnostic imaging initiatives.

Key challenges impacting market and financial outlook

• Pricing pressure from generics, lowering revenue per unit.
• Safety concerns about contrast media adverse reactions.
• Technological shifts, such as MRI, reducing reliance on iodinated contrast agents.
• Regulatory delays or restrictions.

What strategic actions enable OPTIRAY 320 growth?

• Accelerate development of next-generation, lower-risk contrast agents.
• Expand into emerging markets with tailored marketing.
• Strengthen relationships with radiology equipment vendors and healthcare systems.
• Invest in clinical research demonstrating safety profiles.

Key Takeaways

• OPTIRAY 320 operates in a growing but competitive contrast agent market projected to reach USD 6 billion globally by 2030.
• Revenue is sensitive to patent expirations, competition from generics, and safety concerns.
• Regional growth, especially in Asia-Pacific, offers opportunities, but regulatory and safety issues could impede momentum.
• Innovation in safety and formulation remains vital for sustained market share.
• Financial outlook predicts moderate growth through 2027, with potential declines as patent protections expire and cleaner, safer alternatives emerge.

FAQs

Q1: What is the primary use case for OPTIRAY 320?
It is used as a contrast agent in CT scans to improve imaging quality and diagnostic accuracy.

Q2: How does regional regulatory approval affect sales?
Approval in key markets like the US and Europe directly influences sales volume, with delays or restrictions reducing market penetration.

Q3: What risks does patent expiration pose?
It enables generic manufacturers to produce lower-cost alternatives, reducing market share and profitability for branded versions.

Q4: Can safety concerns impact market demand?
Yes, adverse reactions and regulatory warnings about contrast media safety may decrease demand and prompt clinical preference shifts.

Q5: What are growth opportunities for OPTIRAY 320?
Expansion into emerging markets and product innovation focusing on safety improvements offer the main growth avenues.

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Sources

[1] MarketsandMarkets. (2022). Contrast Agents Market Report.