OMNIPAQUE 300 Drug Patent Profile

When do Omnipaque 300 patents expire, and when can generic versions of Omnipaque 300 launch?

Omnipaque 300 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in OMNIPAQUE 300 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 300

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	25
Patent Applications:	3,778
DailyMed Link:	OMNIPAQUE 300 at DailyMed

Recent Clinical Trials for OMNIPAQUE 300

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

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

See all OMNIPAQUE 300 clinical trials

Pharmacology for OMNIPAQUE 300

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

US Patents and Regulatory Information for OMNIPAQUE 300

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 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985		RX	Yes	Yes
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	020608-002	Oct 24, 1995		RX	No	No

Expired US Patents for OMNIPAQUE 300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985	4,021,481
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985	4,396,597
Ge Healthcare	OMNIPAQUE 300	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-003	Dec 26, 1985	4,250,113

International Patents for OMNIPAQUE 300

See the table below for patents covering OMNIPAQUE 300 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

OMNIPAQUE 300 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OMNIPAQUE 300

Introduction to OMNIPAQUE 300

OMNIPAQUE 300, also known as iohexol, is a non-ionic, water-soluble contrast agent used in various medical imaging procedures. It is widely utilized for radiographic imaging of the gastrointestinal (GI) tract, computed tomography (CT) scans, and other diagnostic purposes.

Market Demand and Usage

The demand for OMNIPAQUE 300 is driven by its versatility and efficacy in multiple medical imaging applications. Here are some key areas where OMNIPAQUE 300 is commonly used:

Gastrointestinal Imaging

OMNIPAQUE 300 is indicated for oral, rectal, or enteric tube administration for radiographic imaging of the GI tract, including the esophagus, stomach, small bowel, and colon. Clinical trials have demonstrated its safety, tolerability, and diagnostic quality comparable to or better than other contrast agents like gastrografin and barium sulfate[1].

CT Scans

For CT examinations of the abdomen and pelvis, OMNIPAQUE 300 can be used orally in conjunction with intravenous administration. Studies have shown that it provides diagnostic-quality images with fewer adverse events compared to other contrast agents[1].

Other Diagnostic Procedures

OMNIPAQUE 300 is also used in intrathecal administration for myelography, intraarticular administration for arthrography, and body cavity administration for procedures like hysterosalpingography and herniography[3][4].

Competitive Landscape

The market for contrast agents is competitive, with several other products available, such as Isovue, Visipaque, and barium sulfate.

Radiopacity Comparison

Studies have compared the radiopacity of OMNIPAQUE 300 with other agents. For instance, OMNIPAQUE 300 at 100% concentration has similar mean Hounsfield Units (HU) to Visipaque 320, making it a viable option for patients with chronic kidney or cardiac disease[2].

Market Share

While specific market share data for OMNIPAQUE 300 is not readily available, its broad range of indications and favorable clinical trial results contribute to its strong presence in the market.

Financial Performance

The financial trajectory of OMNIPAQUE 300 is influenced by several factors, including market demand, pricing strategies, and regulatory approvals.

Revenue Streams

Revenue for OMNIPAQUE 300 comes from its use in various medical procedures across different patient populations, including adults and pediatrics. The drug's versatility in both oral and intravenous administrations expands its revenue potential.

Pricing and Cost-Effectiveness

The pricing of OMNIPAQUE 300 is competitive with other contrast agents. Its cost-effectiveness is enhanced by its high diagnostic quality and lower incidence of adverse events, which can reduce overall healthcare costs[1].

Regulatory Approvals and Compliance

Regulatory approvals play a crucial role in the financial performance of OMNIPAQUE 300. The drug has received approvals for various indications based on robust clinical trials, which helps in maintaining and expanding its market presence[1][3].

Market Trends and Growth Drivers

Several trends and drivers influence the market dynamics and financial trajectory of OMNIPAQUE 300:

Increasing Demand for Diagnostic Imaging

The growing need for diagnostic imaging due to an aging population and the rise in chronic diseases drives the demand for contrast agents like OMNIPAQUE 300.

Advancements in Medical Imaging Technology

Advancements in CT and other imaging technologies enhance the diagnostic capabilities of OMNIPAQUE 300, making it a preferred choice for healthcare providers.

Expanding Indications

Continuous research and clinical trials expanding the indications for OMNIPAQUE 300 help in capturing a broader market share.

Challenges and Risks

Despite its strong market position, OMNIPAQUE 300 faces several challenges and risks:

Competitive Pressure

The competitive landscape in the contrast agent market is intense, with other products offering similar or superior benefits.

Regulatory Changes

Changes in regulatory requirements or safety guidelines can impact the market dynamics and financial performance of OMNIPAQUE 300.

Adverse Events and Safety Concerns

Although OMNIPAQUE 300 has a favorable safety profile, any significant adverse events or safety concerns can negatively impact its market performance.

Key Takeaways

• Versatile Applications: OMNIPAQUE 300 is used in a wide range of medical imaging procedures, including GI tract imaging, CT scans, and other diagnostic applications.
• Competitive Radiopacity: It has comparable or superior radiopacity to other contrast agents, making it a preferred choice.
• Strong Clinical Evidence: Robust clinical trials support its safety, tolerability, and diagnostic quality.
• Market Demand: Increasing demand for diagnostic imaging and advancements in medical technology drive its market growth.
• Regulatory Compliance: Continuous regulatory approvals are crucial for its financial performance.

Frequently Asked Questions (FAQs)

Q: What are the common indications for OMNIPAQUE 300? A: OMNIPAQUE 300 is indicated for radiographic imaging of the GI tract, CT scans of the abdomen and pelvis, intrathecal administration for myelography, and other body cavity administrations[1][3].

Q: How does OMNIPAQUE 300 compare to other contrast agents in terms of radiopacity? A: OMNIPAQUE 300 has similar mean Hounsfield Units (HU) to Visipaque 320 at 100% concentration, making it beneficial for patients with chronic kidney or cardiac disease[2].

Q: What are the safety and tolerability profiles of OMNIPAQUE 300? A: Clinical trials have shown that OMNIPAQUE 300 has a favorable safety and tolerability profile, with fewer adverse events compared to other contrast agents like gastrografin[1].

Q: Can OMNIPAQUE 300 be used in pediatric patients? A: Yes, OMNIPAQUE 300 is indicated for oral, rectal, or enteric tube administration in pediatric patients for radiographic imaging of the GI tract and CT scans of the abdomen and pelvis[1].

Q: What are the potential risks associated with OMNIPAQUE 300? A: While OMNIPAQUE 300 has a favorable safety profile, potential risks include adverse events and safety concerns, as well as competitive pressure and regulatory changes[1][3][4].

Cited Sources:

1. Regulatory Decision Summary for Omnipaque - Health Products and Food Branch Inspectorate.
2. Differences in radiopacity among CT contrast agents and ... - Wiley Online Library.
3. OMNIPAQUE (iohexol) oral solution - FDA.
4. OMNIPAQUE™ (iohexol) Injection 300 350 - DailyMed.
5. Iohexol (injection route, intrathecal route, intravenous route) - Mayo Clinic.