OPTIRAY 300 Drug Patent Profile

When do Optiray 300 patents expire, and what generic alternatives are available?

Optiray 300 is a drug marketed by Liebel-flarsheim and is included in two NDAs.

The generic ingredient in OPTIRAY 300 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 300

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 300 at DailyMed

Recent Clinical Trials for OPTIRAY 300

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

Sponsor	Phase
Bayer	Phase 4
Guerbet/Liebel-Flarsheim	Phase 4
Duke Clinical Research Institute	Phase 4

See all OPTIRAY 300 clinical trials

Pharmacology for OPTIRAY 300

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

US Patents and Regulatory Information for OPTIRAY 300

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 300	ioversol	INJECTABLE;INJECTION	019710-004	Jan 22, 1992		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	020923-004	May 13, 1999		RX	Yes	Yes

Expired US Patents for OPTIRAY 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710-004	Jan 22, 1992

International Patents for OPTIRAY 300

See the table below for patents covering OPTIRAY 300 around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3362967
European Patent Office	0083964	COMPOUNDS SUITABLE FOR X-RAY VISUALISATION METHODS
Australia	552188
Japan	H0224252

Supplementary Protection Certificates for OPTIRAY 300

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 300 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Optiray 300 (Ioversol)

Introduction to Optiray 300

Optiray 300, a formulation of the contrast agent ioversol, is widely used in medical imaging procedures such as X-rays, CT scans, and various vascular and cardiac imaging. It is part of the Optiray family of products, which are manufactured by Guerbet, a global leader in medical imaging.

Market Drivers

Increasing Demand for Diagnostic Imaging

The global ioversol market, including Optiray 300, is driven by the increasing demand for diagnostic imaging procedures. This rise is attributed to the growing prevalence of diseases such as cardiovascular disorders, brain disorders, and blood vessel disorders. As the population ages, the incidence of these conditions increases, leading to a higher demand for diagnostic tools like Optiray 300[1][2][3].

Advancements in Medical Imaging Technology

Advancements in X-ray, CT scan, and other radiological diagnostic examinations have significantly boosted the market for ioversol-based contrast agents. The efficiency and accuracy of these technologies have made them indispensable in modern healthcare, further driving the demand for Optiray 300[1][2][3].

Healthcare Spending and Infrastructure

Increased spending on healthcare globally has led to better-equipped hospitals and diagnostic centers. This infrastructure development supports the use of advanced imaging techniques, which in turn fuels the demand for contrast agents like Optiray 300[1][2].

Market Segmentation

By Product

Optiray 300 is one of the several concentrations of ioversol available, including 34%, 51%, 64%, 68%, and 74% solutions. The 300 concentration is specifically used for intra-arterial and intra-venous applications, such as cerebral arteriography, peripheral arteriography, CT imaging of the head and body, venography, and intravenous excretory urography[2][4].

By Application

Optiray 300 is used in various medical imaging applications, including:

• X-ray and CT Scans: For imaging the head and body.
• Brain Disorders: For cerebral arteriography.
• Blood Vessel Disorders: For peripheral arteriography and visceral and renal arteriography.
• Heart Disorders: For coronary arteriography and left ventriculography[2][4].

By Geography

The market for Optiray 300 is segmented geographically into North America, Europe, Asia-Pacific, and Latin America, Middle East, and Africa (LAMEA). Each region has its own growth dynamics influenced by local healthcare infrastructure, regulatory environments, and patient demographics[1][2][3].

Financial Trajectory

Current Market Size and Growth

The global ioversol market, which includes Optiray 300, has witnessed significant growth in recent years. In 2020, the market demand was substantial, and it is predicted to continue growing at a notable CAGR until 2028. The market size is expected to reach several hundred million USD by the end of the forecast period[2][3].

Revenue Projections

The revenue from Optiray 300 and other ioversol formulations is anticipated to increase due to the expanding use of diagnostic imaging. The market is projected to grow steadily, driven by the increasing prevalence of diseases that require advanced imaging techniques[1][2][3].

Key Players and Market Share

Guerbet, the manufacturer of Optiray 300, is a significant player in the ioversol market. Other key players include Jiangsu Hengrui Medicine Co, Mallinckrodt Pharmaceuticals, Liebel-Flarsheim Company LLC, and Ultraject. These companies are continually innovating and expanding their product portfolios, which contributes to the overall market growth[2][3].

Regulatory Approvals and Innovations

FDA Approvals

Guerbet's Optiray Imaging Bulk Package (IBP), which includes Optiray 300, received FDA approval in 2020. This approval allows for the use of Optiray IBP in filling sterile single-use syringes, enhancing efficiency in CT suites and other imaging environments[4][5].

Product Innovations

The introduction of the Optiray IBP has provided healthcare providers with a more efficient and flexible solution. This product can reduce the number of single-dose vials opened and does not require preparation in a laminar flow hood or pharmacy facility, making it a valuable innovation in the field[4][5].

Challenges and Restraints

Safety Concerns

Despite its benefits, the use of Optiray 300 and other ioversol formulations comes with potential risks. Overdose can lead to allergic reactions, breathing problems, swelling, dehydration, and dry skin. These safety concerns can restrain market growth if not properly managed[1].

Regulatory Compliance

Companies must comply with stringent regulatory requirements, which can be a challenge. Ensuring safety and efficacy while meeting regulatory standards is crucial for maintaining market presence and growth[4].

Key Takeaways

• Growing Demand: The market for Optiray 300 is driven by the increasing need for diagnostic imaging due to rising disease prevalence.
• Technological Advancements: Improvements in imaging technologies have boosted the demand for contrast agents like Optiray 300.
• Regulatory Approvals: Recent FDA approvals for Optiray IBP have enhanced the product's efficiency and usability.
• Safety Concerns: Potential side effects and the need for careful dosing are critical factors to consider.
• Market Growth: The market is expected to grow significantly, driven by healthcare spending and infrastructure development.

FAQs

What is Optiray 300 used for?

Optiray 300 is used in various medical imaging procedures, including X-rays, CT scans, cerebral arteriography, peripheral arteriography, and other vascular and cardiac imaging.

Who are the key players in the ioversol market?

Key players include Guerbet, Jiangsu Hengrui Medicine Co, Mallinckrodt Pharmaceuticals, Liebel-Flarsheim Company LLC, and Ultraject.

What are the potential side effects of Optiray 300?

Potential side effects include allergic reactions, breathing problems, swelling, dehydration, and dry skin, especially in cases of overdose.

What is the significance of the FDA approval for Optiray IBP?

The FDA approval for Optiray IBP allows for more efficient use in CT suites by enabling the filling of sterile single-use syringes without the need for a laminar flow hood or pharmacy facility.

How is the market for Optiray 300 expected to grow?

The market is expected to grow significantly due to increasing demand for diagnostic imaging, advancements in medical imaging technology, and increased healthcare spending.

Sources

1. Allied Market Research: Global Ioversol Market.
2. Market Research Store: Ioversol Market Size, Share, Industry Growth Analysis Report.
3. Market Research Intellect: Ioversol-Marktgrößenprognose Größe, Trends und Prognose.
4. PR Newswire: US FDA Approves Guerbet's Optiray® (Ioversol Injection) Imaging Bulk Package.
5. Guerbet: U.S. FDA Approves Guerbet's Optiray® (Ioversol Injection) Imaging Bulk Package.