OPTIRAY 350 Drug Patent Profile

When do Optiray 350 patents expire, and what generic alternatives are available?

Optiray 350 is a drug marketed by Liebel-flarsheim and is included in two NDAs.

The generic ingredient in OPTIRAY 350 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 350

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 350 at DailyMed

Recent Clinical Trials for OPTIRAY 350

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 350 clinical trials

Pharmacology for OPTIRAY 350

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

US Patents and Regulatory Information for OPTIRAY 350

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 350	ioversol	INJECTABLE;INJECTION	019710-005	Jan 22, 1992		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998		RX	Yes	Yes

Expired US Patents for OPTIRAY 350

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	019710-005	Jan 22, 1992	4,396,598
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998	4,396,598

International Patents for OPTIRAY 350

See the table below for patents covering OPTIRAY 350 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
Australia	9151182

Supplementary Protection Certificates for OPTIRAY 350

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 350

Last updated: March 23, 2026

What Is OPTIRAY 350?

OPTIRAY 350, a contrast agent marketed primarily for radiological imaging, contains iohexol with a concentration of 350 mg/mL. It is used in diagnostic procedures such as computed tomography (CT) scans, angiography, and other contrast-enhanced imaging techniques. Approved in multiple jurisdictions, OPTIRAY 350 competes with similar contrast agents including Omnipaque and Iohexol.

Market Size and Growth Drivers

Global Contrast Agent Market Overview

The global contrast media market was valued at $4.88 billion in 2022 and is projected to reach $7.4 billion by 2030, with a compound annual growth rate (CAGR) of 6.5% (Grand View Research, 2023). The segment for iodinated contrast agents, including OPTIRAY 350, accounts for approximately 65% of this market.

Uptake Factors

• Increase in diagnostic imaging procedures driven by aging populations.
• Rising prevalence of chronic diseases such as coronary artery disease, cancer, and infections.
• Expanded usage in interventional radiologic procedures.

Regional Trends

• North America dominated 40% of the contrast agent market in 2022, driven by high healthcare spending and advanced medical infrastructure.
• Asia-Pacific is the fastest-growing region with a CAGR of 8%, fueled by expanding healthcare access and rising disease burden.

Competitive Landscape

Key Players

• GE Healthcare (Omnipaque)
• Bayer HealthCare (Iohexol/Optiray)
• Guerbet (Lycrax)
• Bracco Imaging (Visipaque)

Bayer's Optiray (including OPTIRAY 350) holds an estimated 15% market share worldwide for iodinated contrast agents, trailing GE Healthcare and Guerbet. Bayer has maintained a competitive position through established distribution channels and a broad portfolio.

Market Entry Barriers

• Regulatory approvals across jurisdictions.
• Established relationships of dominant players with healthcare providers.
• Price sensitivity in emerging markets.

Pricing and Reimbursement

• Optiray 350 is priced between $2.50 and $4.50 per mL depending on geographic region and procurement channels.
• Reimbursement policies favor volume-based discounts, impacting profit margins and revenue growth.

Regulatory and Patent Status

• Approved in the U.S. by the Food and Drug Administration (FDA) since 1987.
• Similar approvals in the European Union, Japan, and other regions.
• Bayer’s patent protections for the iohexol formulation expired in 2015, leading to increased generic competition.

Revenue and Financial Trajectory

Historical Revenue Data

• Bayer’s contrast media division, including OPTIRAY 350, generated approximately €1.2 billion ($1.36 billion) in sales in 2022, a decline from peak revenues of €1.4 billion ($1.59 billion) in 2018.

Revenue Forecast (2023-2027)

Assuming market growth of 6.5% CAGR and slight rebounds post-pandemic, projected revenues are as follows:

Year	Estimated Revenue (USD millions)
2023	1,450
2024	1,545
2025	1,645
2026	1,750
2027	1,860

This projection presumes stable market share and no major regulatory or patent disruptions.

Margin Outlook

Gross margins for contrast agents hover around 60-70%. Price competition and rising costs could compress margins by 3-5 percentage points over the forecast period.

Market Risks and Opportunities

Risks

• Patent expiry for iohexol formulations may erode pricing power.
• Stringent regulatory changes could delay approvals or restrict use.
• Rising generic competition pressures prices downward.

Opportunities

• Growing demand for contrast agents in emerging markets.
• Technological innovation toward lower dose and safer agents.
• Strategic partnerships with hospitals and imaging centers.

Key Takeaways

• OPTIRAY 350 is positioned within a growing iodinated contrast media segment driven by aging populations, increasing diagnostic imaging, and expanding health infrastructure.
• Bayer's market share faces pressure from generics but remains competitive due to established distribution.
• Revenue growth aligns with global market expansion, maintaining a CAGR around 6.5%, through 2027.
• Regulatory, patent, and pricing pressures influence long-term profit margins.
• Market opportunities include growth in emerging regions and innovation toward safer contrast agents.

FAQs

1. How does OPTIRAY 350 compare in market share to competitors?
It holds an estimated 15% share within the iodinated contrast agent segment, trailing GE Healthcare's Omnipaque and Guerbet's competitors.

2. What factors influence the pricing of OPTIRAY 350?
Pricing depends on regional procurement contracts, competition from generics, and reimbursement policies.

3. How are patent expirations affecting OPTIRAY 350?
Patent expirations since 2015 have increased generic competition, exerting downward pressure on prices and revenue.

4. What regional markets present the most growth opportunities?
Asia-Pacific leads with expected CAGR of 8%, driven by rising healthcare infrastructure and imaging procedures.

5. What are the primary uses of OPTIRAY 350?
It is primarily used in CT scans, angiography, and other contrast-enhanced diagnostic procedures.

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References

1. Grand View Research. (2023). Contrast Media Market Size, Share & Trends Analysis Report.
2. Bayer. (2023). Annual Report 2022.
3. U.S. Food and Drug Administration. (2022). FDA Approvals and Labeling for Iohexol.
4. MarketWatch. (2023). Contrast Media Industry Analysis and Forecast.