OMNIPAQUE 140 Drug Patent Profile

When do Omnipaque 140 patents expire, and when can generic versions of Omnipaque 140 launch?

Omnipaque 140 is a drug marketed by Ge Healthcare and is included in one NDA.

The generic ingredient in OMNIPAQUE 140 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 140

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	25
Patent Applications:	3,654
DailyMed Link:	OMNIPAQUE 140 at DailyMed

Recent Clinical Trials for OMNIPAQUE 140

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

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

See all OMNIPAQUE 140 clinical trials

Pharmacology for OMNIPAQUE 140

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

US Patents and Regulatory Information for OMNIPAQUE 140

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 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988		RX	Yes	Yes

Expired US Patents for OMNIPAQUE 140

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988	4,021,481
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988	4,396,597
Ge Healthcare	OMNIPAQUE 140	iohexol	INJECTABLE;INJECTION	018956-005	Nov 30, 1988	4,250,113

International Patents for OMNIPAQUE 140

See the table below for patents covering OMNIPAQUE 140 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
Norway	129093

OMNIPAQUE 140 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OMNIPAQUE 140

Introduction to OMNIPAQUE 140

OMNIPAQUE 140, a nonionic, water-soluble x-ray contrast medium containing iohexol, is widely used in various medical imaging procedures. It is marketed by several manufacturers, including GE Healthcare, under the brand name OMNIPAQUE[2].

Clinical Use and Applications

OMNIPAQUE 140 is utilized in a range of diagnostic imaging procedures, including intravenous, intra-arterial, and intrathecal (though the latter is contraindicated for certain concentrations) administrations. It is particularly useful for enhancing the contrast of structures or fluids within the body, making it easier to diagnose conditions such as vascular diseases, tumors, and other abnormalities[4].

Market Demand and Growth

The demand for contrast agents like OMNIPAQUE 140 is driven by the increasing need for diagnostic imaging in healthcare. Factors such as the growing prevalence of chronic diseases, an aging population, and advancements in medical technology contribute to the steady growth in the market for contrast media.

Healthcare Trends

The rise in healthcare spending and the expansion of healthcare services, especially in developing countries, have boosted the demand for diagnostic imaging procedures. This trend is expected to continue, driving the market for OMNIPAQUE 140 and similar contrast agents.

Technological Advancements

Advancements in imaging technologies, such as digital subtraction angiography and computed tomography (CT), have enhanced the utility of contrast agents. These technologies require high-quality contrast media to produce clear and detailed images, further increasing the demand for OMNIPAQUE 140[5].

Financial Trajectory

Revenue Streams

The revenue generated by OMNIPAQUE 140 comes from its widespread use in hospitals, diagnostic centers, and other healthcare facilities. The drug is sold in various concentrations and formats, including glass vials, bottles, and polymer bottles, which helps in diversifying the revenue streams.

Pricing and Competition

The pricing of OMNIPAQUE 140 is influenced by regulatory pricing trends, competition from other contrast agents, and the overall economic conditions in the healthcare sector. Pharmaceutical companies face challenges in securing R&D budgets due to these regulatory pricing trends, which can impact the profitability of drugs like OMNIPAQUE 140[3].

Market Share

OMNIPAQUE, as a brand, holds a significant market share in the contrast media market. The strong clinical efficacy and safety profile of iohexol, combined with effective marketing and distribution strategies, have helped maintain its market position.

Adverse Reactions and Safety Considerations

Safety Profile

While OMNIPAQUE 140 is generally well-tolerated, it can cause adverse reactions such as hypersensitivity, contrast-induced acute kidney injury, and cardiovascular reactions. These safety considerations are crucial for healthcare providers and can impact the financial trajectory through increased costs associated with managing adverse reactions[4][5].

Contraindications

Certain concentrations of OMNIPAQUE are contraindicated for intrathecal use, which can limit its application in some diagnostic procedures. This limitation can affect the overall market demand and revenue.

Regulatory Environment

FDA Approvals and Labeling

OMNIPAQUE 140 has undergone several FDA label updates, which reflect the latest clinical data and safety information. Compliance with FDA regulations is essential for maintaining market approval and ensuring patient safety[1][4][5].

Global Regulations

Regulatory environments vary globally, and compliance with local regulations is critical for market access. Pharmaceutical companies must navigate these regulatory landscapes to ensure the continued availability and profitability of OMNIPAQUE 140.

Future Outlook

Innovations and R&D

Continuous innovation in contrast media is essential for maintaining market competitiveness. Pharmaceutical companies are investing in R&D to develop new contrast agents and improve existing ones, which could impact the future market dynamics of OMNIPAQUE 140[3].

Market Expansion

Expanding into new markets, particularly in developing countries, offers significant growth opportunities for OMNIPAQUE 140. However, this expansion must be balanced with the need to comply with local regulations and address any unique market challenges.

Key Takeaways

• Market Demand: Driven by increasing healthcare needs and advancements in medical technology.
• Financial Trajectory: Influenced by regulatory pricing trends, competition, and safety considerations.
• Safety Profile: Generally well-tolerated but with potential for adverse reactions.
• Regulatory Environment: Compliance with FDA and global regulations is crucial.
• Future Outlook: Continuous innovation and market expansion are key to maintaining market position.

FAQs

What is OMNIPAQUE 140 used for?

OMNIPAQUE 140 is used as a contrast agent in various diagnostic imaging procedures, including intravenous, intra-arterial, and certain intrathecal administrations.

What are the common adverse reactions associated with OMNIPAQUE 140?

Common adverse reactions include hypersensitivity, contrast-induced acute kidney injury, and cardiovascular reactions such as hemodynamic disturbances and cardiac arrest.

Is OMNIPAQUE 140 contraindicated for any specific use?

Yes, OMNIPAQUE 140 is contraindicated for intrathecal use at certain concentrations and for parenteral administration of the oral solution.

How does the regulatory environment impact the market for OMNIPAQUE 140?

Compliance with FDA and global regulations is essential for maintaining market approval and ensuring patient safety, which can significantly impact the financial trajectory of the drug.

What are the future growth opportunities for OMNIPAQUE 140?

Future growth opportunities include expanding into new markets, particularly in developing countries, and continuous innovation in contrast media to maintain market competitiveness.

Sources

1. OMNIPAQUE™ (iohexol) Injection Label - FDA.
2. Iohexol manufacturers - Pipelinepharma.
3. Daiichi Sankyo Group IR Report 2015 - Daiichi Sankyo.
4. OMNIPAQUE (iohexol) oral solution Label - FDA.
5. OMNIPAQUE (iohexol) oral solution Label - FDA.