OMNIPAQUE 240 Drug Patent Profile

When do Omnipaque 240 patents expire, and when can generic versions of Omnipaque 240 launch?

Omnipaque 240 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in OMNIPAQUE 240 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 240

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	25
Patent Applications:	3,607
DailyMed Link:	OMNIPAQUE 240 at DailyMed

Recent Clinical Trials for OMNIPAQUE 240

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 240 clinical trials

Pharmacology for OMNIPAQUE 240

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

US Patents and Regulatory Information for OMNIPAQUE 240

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 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985		RX	Yes	Yes
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	020608-001	Oct 24, 1995		DISCN	No	No

Expired US Patents for OMNIPAQUE 240

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 240	iohexol	SOLUTION;INJECTION, ORAL, RECTAL	018956-002	Dec 26, 1985

International Patents for OMNIPAQUE 240

See the table below for patents covering OMNIPAQUE 240 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

OMNIPAQUE 240 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OMNIPAQUE 240

Introduction

OMNIPAQUE 240, a nonionic, water-soluble radiographic contrast medium, is a key product in the diagnostic imaging market. Developed by GE Healthcare, it is used for various medical imaging procedures, including myelography, computed tomography (CT), and gastrointestinal (GI) tract imaging.

Market Indications and Usage

OMNIPAQUE 240 is indicated for several medical imaging applications:

• Intrathecal Administration: It is used for myelography, cisternography, and ventriculography in adults and children[4].
• Oral Administration: For radiographic imaging of the GI tract, including the esophagus, stomach, small bowel, and colon in adults and children[1].
• CT of the Abdomen and Pelvis: Used in conjunction with intravenous administration for contrast-enhanced CT scans[1].

Clinical Efficacy and Safety

The efficacy and safety of OMNIPAQUE 240 have been demonstrated through several clinical trials. For instance, studies N-137 and PS-632 showed that OMNIPAQUE 350 (which is often used in similar indications) had comparable or significantly better diagnostic quality images compared to the active control gastrografin 370[1]. The safety profile of OMNIPAQUE 240 is favorable, with common adverse reactions including headache, nausea, and vomiting, which are generally mild and transient[4].

Market Demand and Growth

The demand for radiographic contrast media like OMNIPAQUE 240 is driven by the increasing need for diagnostic imaging in various medical specialties. The growing prevalence of diseases that require imaging diagnostics, such as gastrointestinal disorders and neurological conditions, contributes to the market growth.

Competitive Landscape

The market for radiographic contrast media is competitive, with several other products available, including barium sulfate and gastrografin. However, OMNIPAQUE 240 has a strong position due to its favorable safety and efficacy profile, as well as its versatility in different imaging procedures[1][4].

Financial Performance

While specific financial data for OMNIPAQUE 240 alone is not publicly disclosed, the overall performance of GE Healthcare, the manufacturer, provides insights into the product's financial trajectory. GE Healthcare is a significant player in the medical imaging market, and its revenue is influenced by the sales of products like OMNIPAQUE.

Revenue and Sales Projections

GE Healthcare's revenue has been stable, with a focus on innovative products and expanding its global market presence. The company's financial reports indicate a steady revenue stream, which is partly attributed to the sales of diagnostic imaging products, including OMNIPAQUE[3].

Regulatory Environment

The regulatory approval and compliance of OMNIPAQUE 240 are crucial for its market presence. Health Canada's approval, as outlined in the Regulatory Decision Summary, highlights the product's safety and efficacy, which supports its market authorization[1].

Pricing and Cost Considerations

The pricing of OMNIPAQUE 240 is influenced by factors such as production costs, market competition, and regulatory requirements. The product is available by prescription only, which can impact its pricing strategy and reimbursement policies[1].

Distribution and Storage

OMNIPAQUE 240 is distributed through various medical supply channels and must be stored under controlled conditions to maintain its efficacy. It should be protected from strong daylight and direct exposure to sunlight, and stored at controlled room temperature[5].

Future Outlook

The future outlook for OMNIPAQUE 240 is positive, driven by advancements in medical imaging technologies and the increasing demand for diagnostic procedures. GE Healthcare's commitment to innovation and expanding its product portfolio is expected to further enhance the market position of OMNIPAQUE 240.

Key Takeaways

• Versatile Indications: OMNIPAQUE 240 is used in various diagnostic imaging procedures, including intrathecal administration and oral administration for GI tract imaging.
• Favorable Safety Profile: The product has a well-documented safety profile with common adverse reactions being mild and transient.
• Strong Market Position: It competes effectively in the radiographic contrast media market due to its efficacy and safety.
• Stable Financial Performance: GE Healthcare's overall financial stability supports the continued market presence of OMNIPAQUE 240.
• Regulatory Compliance: The product has received regulatory approvals, ensuring its continued market authorization.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for OMNIPAQUE 240? A: OMNIPAQUE 240 is indicated for intrathecal administration in adults and children for myelography and CT scans, as well as for oral administration for radiographic imaging of the GI tract[1][4].

Q: How safe is OMNIPAQUE 240? A: OMNIPAQUE 240 has a favorable safety profile, with common adverse reactions including headache, nausea, and vomiting, which are generally mild and transient[4].

Q: Who is the manufacturer of OMNIPAQUE 240? A: OMNIPAQUE 240 is manufactured by GE Healthcare Canada Inc.[1].

Q: What are the storage requirements for OMNIPAQUE 240? A: OMNIPAQUE 240 should be protected from strong daylight and direct exposure to sunlight and stored at controlled room temperature[5].

Q: Is OMNIPAQUE 240 available over-the-counter or by prescription only? A: OMNIPAQUE 240 is available by prescription only[1].