OPTIRAY 160 Drug Patent Profile

When do Optiray 160 patents expire, and what generic alternatives are available?

Optiray 160 is a drug marketed by Liebel-flarsheim and is included in one NDA.

The generic ingredient in OPTIRAY 160 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 160

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	3
Patent Applications:	2,517
DailyMed Link:	OPTIRAY 160 at DailyMed

Recent Clinical Trials for OPTIRAY 160

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 160 clinical trials

Pharmacology for OPTIRAY 160

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

US Patents and Regulatory Information for OPTIRAY 160

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 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988		DISCN	No	No

Expired US Patents for OPTIRAY 160

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988	4,396,598

International Patents for OPTIRAY 160

See the table below for patents covering OPTIRAY 160 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 160

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 160

Last updated: March 4, 2026

What is OPTIRAY 160?

OPTIRAY 160 is a synthetic iodinated contrast agent used primarily in diagnostic imaging procedures such as computed tomography (CT) scans. It contains iohexol, a non-ionic, low-osmolar contrast agent. Approved by the U.S. Food and Drug Administration (FDA), it is marketed by Guerbet and available in multiple regions globally.

Market Size and Growth Drivers

Current Market Landscape

The global contrast agents market was valued at approximately USD 4.2 billion in 2022 and is projected to reach USD 6.6 billion by 2030, growing at a compound annual growth rate (CAGR) of 6.2% (Grand View Research, 2023). Iodinated contrast agents, including OPTIRAY 160, account for the majority of this market segment.

Key Growth Factors

• Increase in aging population leading to higher diagnostic imaging rates.
• Rising prevalence of cardiovascular, infectious, and oncological diseases requiring imaging.
• Expansion of hospital and outpatient imaging infrastructure, especially in emerging markets.

Regional Dynamics

Region	Market Share (2022)	Growth Rate (CAGR 2022-2030)	Key Factors
North America	40%	5.8%	High healthcare expenditure, advanced diagnostics infrastructure
Europe	25%	6.1%	Aging population, regulatory approvals
Asia-Pacific	20%	8.2%	Rapid infrastructure development, large patient base
Rest of World	15%	6.4%	Increasing healthcare access, emerging markets

Competitive Landscape

Major players besides Guerbet include Bayer, GE Healthcare, Bracco Imaging, and Bayer. These companies compete through pricing, regulatory approvals, and product differentiation.

Patent and Regulatory Status

• OPTIRAY 160 holds exclusivity in multiple markets due to proprietary formulation patents.
• Regulatory approvals extend until at least 2025, with some markets granting extensions or pending approvals.

Financial Trajectory

Revenue Trends

Guerbet's contrast agents segment, which encompasses OPTIRAY 160, generated approximately USD 280 million in 2022 and has shown steady growth aligned with the broader market.

Pricing and Market Penetration

Average price per dose in North America is approximately USD 15-20. Pricing elasticity varies with healthcare policies, reimbursement policies, and regional competition. Market penetration is higher in developed markets, projected to increase in emerging regions with healthcare infrastructure expansion.

R&D and Pipeline

Guerbet continues R&D investments totaling approximately USD 50 million annually for contrast media innovations. Pipeline products aim to improve safety profiles and imaging efficacy, potentially capturing additional market share.

Market Entry Barriers

• Regulatory approval processes extending 1-3 years.
• High R&D costs for formulation and safety validation.
• Established market dominance by incumbent players requiring aggressive marketing strategies.

Financial Risks

• Regulatory delays or reclassification affecting market launch timelines.
• Pricing pressures due to healthcare cost containment initiatives.
• Competition from alternative imaging modalities and non-iodinated contrast agents.

Revenue Forecasts

Based on current market growth rates and Guerbet’s market share estimates, OPTIRAY 160's sales are projected to grow from USD 100 million in 2022 to approximately USD 180 million by 2030, assuming steady market expansion and ongoing patent protections.

Key Takeaways

• The iodinated contrast agent market is projected to grow at 6.2% CAGR through 2030.
• OPTIRAY 160 benefits from market demand, aging populations, and expanding medical infrastructure.
• Revenue growth will be influenced by regional adoption, regulatory status, and competitive positioning.
• Price sensitivity and reimbursement policies will impact profit margins.
• Ongoing R&D investments are critical to preserve market relevance.

Five FAQs

1. What distinguishes OPTIRAY 160 from other contrast agents?
It offers a low-osmolar, non-ionic formulation that reduces adverse reactions compared to older, ionic agents.

2. How significant is regulatory approval for market expansion?
Critical; delays or rejections can postpone revenue streams and enable competitors to gain market share.

3. What are the primary risks for OPTIRAY 160’s financial performance?
Regulatory setbacks, pricing pressures, and competition from alternative imaging agents.

4. Which regions are most promising for growth?
Asia-Pacific and Latin America, due to expanding healthcare access and infrastructure.

5. What innovations are in the pipeline for OPTIRAY 160?
Improvements in safety profiles, reduced side effects, and enhanced imaging quality to differentiate from competitors.

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Sources:

[1] Grand View Research. (2023). Contrast Agents Market Size, Share & Trends Analysis Report.
[2] FDA. (2022). FDA Approved Contrast Agents.
[3] Guerbet. (2022). Annual Report and Product Portfolio.