IOVERSOL - Generic Drug Details

What are the generic sources for ioversol and what is the scope of patent protection?

Ioversol is the generic ingredient in five branded drugs marketed by Liebel-flarsheim and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for ioversol. One supplier is listed for this compound.

Summary for IOVERSOL

US Patents:	0
Tradenames:	5
Applicants:	1
NDAs:	2
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	5
Patent Applications:	3,304
What excipients (inactive ingredients) are in IOVERSOL?	IOVERSOL excipients list
DailyMed Link:	IOVERSOL at DailyMed

Recent Clinical Trials for IOVERSOL

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 IOVERSOL clinical trials

Pharmacology for IOVERSOL

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

Anatomical Therapeutic Chemical (ATC) Classes for IOVERSOL

V08AB	Watersoluble, nephrotropic, low osmolar X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for IOVERSOL

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 240	ioversol	INJECTABLE;INJECTION	019710-002	Dec 30, 1988		DISCN	Yes	No
Liebel-flarsheim	OPTIRAY 350	ioversol	INJECTABLE;INJECTION	020923-003	May 28, 1998		RX	Yes	Yes
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	020923-004	May 13, 1999		RX	Yes	Yes

Expired US Patents for IOVERSOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Liebel-flarsheim	OPTIRAY 160	ioversol	INJECTABLE;INJECTION	019710-003	Dec 30, 1988
Liebel-flarsheim	OPTIRAY 240	ioversol	INJECTABLE;INJECTION	020923-001	May 28, 1998
Liebel-flarsheim	OPTIRAY 300	ioversol	INJECTABLE;INJECTION	019710-004	Jan 22, 1992
Liebel-flarsheim	OPTIRAY 320	ioversol	INJECTABLE;INJECTION	019710-001	Dec 30, 1988

Market Dynamics and Financial Trajectory of Ioversol

Market Overview

Ioversol, a sterile contrast dye used in diagnostic radiocontrast agents, is experiencing significant growth driven by various market dynamics. The global Ioversol market is projected to be valued at $857 million by 2026, growing at a CAGR of 7.2% from 2021 to 2026[1].

Key Drivers

Increasing Demand for Diagnostic Procedures

The rise in the incidence of heart diseases, respiratory diseases, and other health conditions is driving the demand for Ioversol. Diagnostic procedures such as CT scans and X-ray imaging, which rely on Ioversol, are becoming more common, thereby boosting market growth[1].

Healthcare Infrastructure Expansion

The growth in healthcare infrastructure globally, particularly in regions like North America, Europe, and Asia-Pacific, is a significant driver. Advanced healthcare systems and favorable government initiatives are contributing to the increased adoption of Ioversol in these regions[4].

COVID-19 Impact

The COVID-19 pandemic has accelerated the demand for Ioversol due to the increased need for diagnostic imaging to detect complications in patients. This has led to a considerable growth in the market during the pandemic period[1][4].

Market Segmentation

By Type

The Ioversol market is segmented into various concentrations, with the Ioversol 64% Injectable Solution holding the largest share of 30% in 2020. This segment is widely used in radiographic body imaging due to its ease of use and low cost[1].

By Packaging

Power Injector Syringes dominate the packaging segment with a 33% share in 2020. These syringes are FDA-approved, affordable, and easy to use, making them a preferred choice for administering contrast dye[1].

By Application

Radiological and diagnostic examinations hold the largest share of 40% in the market. Ioversol is used in various procedures including MRI scans, coronary calcium scoring, and other diagnostic examinations[1].

By Geography

North America holds the largest market share due to its well-established healthcare infrastructure and high adoption of advanced diagnostic techniques. Europe and Asia-Pacific also contribute significantly to the market growth[1][4].

Financial Trajectory

Market Size and Growth

The Ioversol market is expected to grow from $857 million by 2026, with a CAGR of 7.2% during the forecast period from 2021 to 2026. This growth is driven by the increasing demand for diagnostic imaging and the expansion of healthcare infrastructure[1].

Revenue Projections

The market is projected to see sustained growth from 2023 to 2031, with an anticipated annual growth rate of 3 to 5%. This positive outlook is supported by the increasing prevalence of chronic diseases and the growing need for advanced diagnostic procedures[2].

Competitive Landscape

The global Ioversol market is highly competitive, with key players such as Liebel-Flarsheim Company LLC, Guerbet, Jiangsu Hengrui Medicine Co, Mallinckrodt Pharmaceuticals, and Ultraject. These companies are involved in intense research, development, and technological advancements to differentiate their products and capture market share[2][4].

SWOT Analysis

Strengths

• Wide application in various diagnostic imaging procedures
• High demand due to the increasing prevalence of chronic diseases
• Technological advancements in medical imaging[4]

Weaknesses

• Potential risk of adverse reactions associated with contrast agents
• Stringent regulatory requirements for manufacturing and distribution[4]

Opportunities

• Growing demand for diagnostic imaging in emerging economies
• Technological advancements and research and development activities
• Increasing awareness about early diagnosis and preventive healthcare[4]

Threats

• Availability of alternative imaging techniques
• Economic volatility and regulatory complexities in certain regions[4]

Key Trends

Impact of COVID-19

The pandemic led to a temporary decline in elective procedures but increased the demand for emergency imaging, such as CT scans for COVID-19 diagnosis. This shift highlighted the critical role of Ioversol in emergency imaging procedures[4].

Shift Towards Telemedicine

The pandemic accelerated the adoption of telemedicine, resulting in the increased use of Ioversol-based imaging techniques in remote settings[4].

Supply Chain Disruptions

Despite supply chain disruptions, market players have taken measures to ensure the continuity of the supply chain and address the increased demand for Ioversol[4].

Emphasis on Patient Safety

Ioversol, with its lower risk of adverse reactions, has been preferred to minimize potential complications and optimize patient safety during the pandemic[4].

Regional Dynamics

North America

Dominates the global Ioversol market due to well-established healthcare infrastructure, high adoption of advanced diagnostic techniques, and favorable reimbursement policies[4].

Europe

Holds a significant share driven by advanced healthcare systems, favorable government initiatives, and the increasing prevalence of chronic diseases[4].

Asia-Pacific

Expected to witness significant growth due to the rising geriatric population, improving healthcare infrastructure, and increasing investments in healthcare[4].

Latin America and Middle East & Africa

Present lucrative opportunities with improving healthcare infrastructure and rising disposable incomes, though challenges such as economic volatility and regulatory complexities need to be addressed[4].

Key Takeaways

• The Ioversol market is driven by the increasing demand for diagnostic imaging and the expansion of healthcare infrastructure.
• The market is expected to grow significantly, with a projected value of $857 million by 2026.
• Key players are focusing on research, development, and technological advancements to capture market share.
• Regional variations in market dynamics are crucial for tailoring strategies to capitalize on specific opportunities and overcome challenges.

FAQs

Q: What is the projected market size of Ioversol by 2026? A: The Ioversol market is expected to be valued at $857 million by the end of 2026[1].

Q: What is the CAGR of the Ioversol market from 2021 to 2026? A: The Ioversol market is set to grow at a CAGR of 7.2% during the forecast period from 2021 to 2026[1].

Q: Which region dominates the global Ioversol market? A: North America dominates the global Ioversol market due to its well-established healthcare infrastructure and high adoption of advanced diagnostic techniques[4].

Q: What are the main drivers of the Ioversol market? A: The main drivers include the increasing demand for diagnostic procedures, expansion of healthcare infrastructure, and the impact of the COVID-19 pandemic[1][4].

Q: What are the potential risks associated with Ioversol? A: The potential risks include adverse reactions associated with contrast agents and stringent regulatory requirements for manufacturing and distribution[4].

Cited Sources

1. IndustryARC, "Ioversol Market – Forecast (2021-2026)".
2. MarketResearchIntellect, "Ioversol-Marktgrößenprognose Größe, Trends und Prognose".
3. OpenPR, "Ioversol Market Seeking Growth from Emerging Study Drivers".
4. MarkWiderResearch, "Global Ioversol Market 2024-2032 | Size, Share, Growth".