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:	73
Clinical Trials:	3
Patent Applications:	1,980
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
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998

International Patents for OPTIRAY 350

See the table below for patents covering OPTIRAY 350 around the world.

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

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

OPTIRAY 350 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Optiray 350 (Ioversol Injection)

Introduction

Optiray 350, a formulation of ioversol, is a nonionic iodinated contrast medium used in various medical imaging procedures. Understanding the market dynamics and financial trajectory of this drug is crucial for stakeholders in the healthcare and pharmaceutical industries.

Market Drivers

The global market for ioversol, including Optiray 350, is driven by several key factors:

Increase in Medical Imaging Procedures

The rise in the number of accidents, along with an increase in the prevalence of bone-related diseases and kidney problems, has led to a higher demand for diagnostic imaging procedures such as X-rays, CT scans, and angiographies. This increased demand directly fuels the growth of the ioversol market[1].

Growing Geriatric Population

The growth in the geriatric population has resulted in an increase in orthopedic and cardiovascular disorders, further boosting the demand for diagnostic imaging and, consequently, for contrast agents like Optiray 350[1].

Advancements in Diagnostic Technologies

Advancements in X-ray, CT scan, and other radiological and diagnostic examinations have expanded the applications of ioversol, providing new opportunities for market growth[1].

Market Segmentation

The ioversol market, including Optiray 350, is segmented based on type, application, and geography.

Type

Optiray 350 is one of several concentrations of ioversol available, including 34%, 51%, 64%, 68%, and 74% injectable solutions. Optiray 350, specifically, is a 74% injectable solution[1][3].

Application

Optiray 350 is indicated for various applications, including peripheral and coronary arteriography, left ventriculography, contrast-enhanced computed tomographic imaging of the head and body, intravenous excretory urography, and intravenous digital subtraction angiography[3][4].

Geography

The market is analyzed across different geographies, including North America, Europe, Asia-Pacific, and LAMEA (Latin America, Middle East, and Africa)[1].

Financial Trajectory

Revenue Growth

Guerbet, the company behind Optiray 350, has seen steady revenue growth. For instance, in the first half of 2023, Guerbet's sales totalled €378.6 million, up 2% from the first half of 2022[5].

Market Expansion

The approval of Optiray Imaging Bulk Package (IBP) by the US FDA in 2020 marked a significant milestone, offering customers greater flexibility and efficiency in the CT suite. This innovation has likely contributed to the financial growth of Guerbet by reducing the number of single-dose vials needed and streamlining the preparation process[4].

Research and Development

Guerbet dedicates 9% of its revenue to Research and Development, which is crucial for maintaining market competitiveness and driving innovation in the field of contrast media. This commitment to R&D helps in continuously improving and expanding the product portfolio, including Optiray 350[4].

Challenges and Restraints

Adverse Reactions

Despite its benefits, Optiray 350 can cause adverse reactions, ranging from mild to severe. These include allergic reactions, breathing problems, swelling, and in rare cases, life-threatening reactions such as anaphylactic shock. These risks can restrain market growth and impact patient compliance[2][3].

Regulatory Considerations

The use of ioversol must be assessed on an individual risk-to-benefit basis, and it is contraindicated in patients with symptomatic hyperthyroidism. These regulatory considerations can affect the market dynamics and the financial performance of the drug[4].

Competitive Landscape

Guerbet, as a global leader in medical imaging, faces competition from other manufacturers of contrast agents. However, its innovative product portfolio, including the Optiray IBP, and its long-standing presence in the market contribute to its competitive edge[4].

Future Outlook

Increasing Demand for Diagnostic Imaging

The ongoing increase in the demand for diagnostic imaging procedures due to rising healthcare needs and advancements in technology is expected to continue driving the market for Optiray 350.

Innovations in Product Formulations

Guerbet's continuous innovation, such as the development of the Optiray IBP, is likely to enhance efficiency and safety in medical imaging, further boosting the market for Optiray 350.

Expanding Geographical Presence

The market for ioversol is expected to grow across various geographies, particularly in regions with increasing healthcare spending and improving diagnostic infrastructure[1].

Key Takeaways

• Market Drivers: The market for Optiray 350 is driven by the rise in medical imaging procedures, growing geriatric population, and advancements in diagnostic technologies.
• Market Segmentation: The market is segmented by type, application, and geography.
• Financial Trajectory: Guerbet has seen steady revenue growth, with significant contributions from innovations like the Optiray IBP.
• Challenges: Adverse reactions and regulatory considerations are key restraints.
• Future Outlook: Increasing demand for diagnostic imaging, innovations in product formulations, and expanding geographical presence are expected to drive future growth.

FAQs

What is Optiray 350 used for?

Optiray 350 is used for various medical imaging procedures, including peripheral and coronary arteriography, left ventriculography, contrast-enhanced CT imaging of the head and body, intravenous excretory urography, and intravenous digital subtraction angiography[3][4].

What are the common side effects of Optiray 350?

Common side effects include nausea, vomiting, dry mouth, and ringing in the ears. More severe reactions can include allergic reactions, breathing problems, and in rare cases, life-threatening reactions[2][3].

Who is the manufacturer of Optiray 350?

Optiray 350 is manufactured by Guerbet, a global leader in medical imaging[4].

What is the significance of the Optiray Imaging Bulk Package (IBP)?

The Optiray IBP offers greater flexibility and efficiency in the CT suite by allowing the filling of sterile single-use syringes without requiring preparation in a laminar flow hood or pharmacy facility[4].

Is Optiray 350 safe for pediatric use?

Safety and effectiveness of Optiray 350 have been established in pediatric patients for certain applications, such as angiocardiography and CT imaging of the head and body, but not for patients less than 1 month of age[3][4].

Sources

1. Allied Market Research - Global Ioversol Market
2. Mayo Clinic - Ioversol (injection route)
3. FDA - Optiray® Pharmacy Bulk Package
4. PR Newswire - US FDA Approves Guerbet's Optiray® (Ioversol Injection) Imaging Bulk Package
5. Guerbet - First-half 2023 revenue