OMNIPAQUE 9 Drug Patent Profile

When do Omnipaque 9 patents expire, and what generic alternatives are available?

Omnipaque 9 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 9 is iohexol. There are three drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iohexol profile page.

Summary for OMNIPAQUE 9

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	25
DailyMed Link:	OMNIPAQUE 9 at DailyMed

Recent Clinical Trials for OMNIPAQUE 9

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

Sponsor	Phase
Centre for Interdisciplinary Research in Rehabilitation of Greater Montreal	Phase 4
Claire Bourgeois	Phase 4
Fédération des médecins résidents du Québec	Phase 4

See all OMNIPAQUE 9 clinical trials

Pharmacology for OMNIPAQUE 9

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

US Patents and Regulatory Information for OMNIPAQUE 9

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	OMNIPAQUE 9	iohexol	SOLUTION;ORAL	018956-008	Apr 17, 2018		RX	Yes	Yes

International Patents for OMNIPAQUE 9

See the table below for patents covering OMNIPAQUE 9 around the world.

Country	Patent Number	Title	Estimated Expiration
Sweden	445971	FORFARANDE FOR FRAMSTELLNING AV INJICERBART RONTGENKONTRASTMEDEL SAMT EN LOSNING AV NEMNDA MEDEL
Ireland	48437	A PROCESS FOR THE PREPARATION OF A STERILE INJECTABLE PHYSIOLOGICALLY ACCEPTABLE SOLUTION OF AN X-RAY CONTRAST AGENT AND SOLUTIONS OF THE X-RAY CONTRAST AGENT AND A BUFFER
Finland	792101
France	2053037
Canada	935153	2,4,6-TRIIODOBENZOYL AMINES USED AS X-RAY CONTRAST AGENTS
Japan	S5321137	XXRAY CONTRAST MEDIUM

OMNIPAQUE 9 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OMNIPAQUE (iohexol)

Introduction to OMNIPAQUE (iohexol)

OMNIPAQUE, also known as iohexol, is a non-ionic, water-soluble contrast agent used in various medical imaging procedures. It is available in different concentrations and forms, including injections and oral solutions, and is indicated for a range of applications such as intrathecal, intravascular, oral, rectal, intraarticular, and body cavity use[2][4].

Market Size and Growth

The global iohexol market, which includes OMNIPAQUE, has been experiencing significant growth. As of 2022, the global iohexol market size was valued at around USD 1.5 billion. This market is projected to grow at a compound annual growth rate (CAGR) over the forecast period, driven by increasing demand for diagnostic imaging procedures and advancements in healthcare infrastructure[1].

Geographical Analysis

The market for iohexol is geographically diverse, with key regions including North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. Each region has its own set of trends, economic impacts, and investment patterns.

• North America: This region is one of the largest markets for iohexol due to advanced healthcare infrastructure and high adoption rates of diagnostic imaging technologies.
• Europe: Europe also represents a significant market, driven by a large patient population and robust healthcare systems.
• Asia-Pacific: This region is expected to show rapid growth due to increasing healthcare expenditure and a growing demand for diagnostic services.
• Latin America and Middle East & Africa: These regions are also growing, albeit at a slower pace, due to improving healthcare facilities and increasing awareness of diagnostic imaging[1].

Product Types and Applications

OMNIPAQUE is available in various concentrations, such as 300 mg Iodine/mL and 350 mg Iodine/mL, each with specific indications.

• Product Types: The product is categorized based on its concentration and form (injection or oral solution). For example, OMNIPAQUE 300 and OMNIPAQUE 350 are used for different procedures like arthrography and oral pass-thru examinations of the gastrointestinal tract[5].
• Applications: The drug is used in a wide range of medical imaging procedures, including:
  • Intrathecal Use: For myelography and other spinal procedures.
  • Intravascular Use: For angiography and other vascular procedures.
  • Oral Use: For gastrointestinal tract examinations.
  • Intraarticular Use: For joint imaging.
  • Body Cavity Use: For imaging of body cavities[2][4].

Market Attractiveness and Strategic Insights

The market attractiveness of iohexol is influenced by several factors, including the growing need for diagnostic imaging, advancements in technology, and the presence of key market vendors.

• Bps Analysis: This analysis helps in understanding the market share and competitive landscape of different product types and applications.
• Market Attractiveness: The attractiveness of the market is high due to the increasing demand for non-ionic contrast agents like iohexol, which have fewer side effects compared to ionic agents[1].

Financial Performance and Projections

The financial performance of the iohexol market, including OMNIPAQUE, is robust and expected to continue growing.

• Historical Market Value: The market value has shown steady growth from 2014 to 2022, with a significant increase in recent years.
• Market Value Forecast: The market is projected to continue its growth trajectory, reaching new heights by 2032, driven by increasing healthcare spending and technological advancements[1].

Competitive Landscape

The market for iohexol is competitive, with several key vendors playing significant roles.

• Leading Market Vendors: Companies like GE Healthcare, which markets OMNIPAQUE, are major players in the iohexol market. These companies invest heavily in research and development to maintain their market position[1].

Adverse Reactions and Safety Considerations

While OMNIPAQUE is generally safe, it can cause adverse reactions, especially if not used properly.

• Common Adverse Reactions: These include headaches, pain, nausea, vomiting, and dizziness. More severe reactions such as contrast-induced acute kidney injury, cardiovascular adverse reactions, and thyroid dysfunction in pediatric patients can also occur[2][4].

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of iohexol.

• FDA Approvals: OMNIPAQUE has received approvals from regulatory bodies like the FDA for various indications. Compliance with regulatory standards is essential for market presence[4].

Market Trends and Future Outlook

The future outlook for the iohexol market, including OMNIPAQUE, is positive due to several trends:

• Increasing Demand for Diagnostic Imaging: The growing need for accurate and safe diagnostic imaging procedures drives the demand for contrast agents like iohexol.
• Advancements in Technology: Continuous advancements in medical imaging technologies further enhance the market for iohexol.
• Expanding Healthcare Infrastructure: Improvements in healthcare infrastructure, especially in emerging markets, contribute to the growth of the iohexol market[1].

Key Takeaways

• The global iohexol market, including OMNIPAQUE, is valued at around USD 1.5 billion as of 2022 and is projected to grow significantly.
• The market is geographically diverse, with North America, Europe, and Asia-Pacific being key regions.
• OMNIPAQUE is used in various medical imaging procedures and is available in different concentrations.
• The market is competitive, with key vendors like GE Healthcare playing significant roles.
• Adverse reactions and safety considerations are crucial, and regulatory compliance is essential.
• The future outlook is positive, driven by increasing demand for diagnostic imaging and advancements in technology.

FAQs

What is OMNIPAQUE (iohexol) used for?

OMNIPAQUE (iohexol) is a contrast agent used in various medical imaging procedures, including intrathecal, intravascular, oral, rectal, intraarticular, and body cavity use.

What are the common adverse reactions associated with OMNIPAQUE?

Common adverse reactions include headaches, pain, nausea, vomiting, and dizziness. More severe reactions such as contrast-induced acute kidney injury and cardiovascular adverse reactions can also occur.

What are the different concentrations of OMNIPAQUE available?

OMNIPAQUE is available in concentrations of 300 mg Iodine/mL and 350 mg Iodine/mL.

Who are the key vendors in the iohexol market?

Key vendors include companies like GE Healthcare, which markets OMNIPAQUE.

What is the projected growth rate of the global iohexol market?

The global iohexol market is projected to grow at a significant compound annual growth rate (CAGR) over the forecast period.

Sources

1. KD Market Insights: Iohexol Market Size, Share, Growth, Trends And Future Outlook 2032
2. GE Healthcare: OMNIPAQUE (iohexol) oral solution
3. DAIICHI SANKYO CO., LTD.: Annual Report 2010
4. FDA: OMNIPAQUE (iohexol) oral solution
5. DailyMed: OMNIPAQUE™ (iohexol) Injection 300 350