OMNIPAQUE 350 Drug Patent Profile

Which patents cover Omnipaque 350, and when can generic versions of Omnipaque 350 launch?

Omnipaque 350 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in OMNIPAQUE 350 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 350

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	98
Clinical Trials:	25
Patent Applications:	3,598
DailyMed Link:	OMNIPAQUE 350 at DailyMed

Recent Clinical Trials for OMNIPAQUE 350

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 350 clinical trials

Pharmacology for OMNIPAQUE 350

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

US Patents and Regulatory Information for OMNIPAQUE 350

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 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985		RX	Yes	Yes
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	020608-003	Oct 24, 1995		RX	No	No

Expired US Patents for OMNIPAQUE 350

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985
Ge Healthcare	OMNIPAQUE 350	iohexol	SOLUTION;INJECTION, ORAL	018956-004	Dec 26, 1985

International Patents for OMNIPAQUE 350

See the table below for patents covering OMNIPAQUE 350 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 350 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for OMNIPAQUE 350

Introduction

OMNIPAQUE 350, a non-ionic, water-soluble contrast agent containing iohexol, is widely used in radiographic imaging procedures. To understand its market dynamics and financial trajectory, it is essential to delve into its clinical indications, market performance, and the broader pharmaceutical landscape.

Clinical Indications and Efficacy

OMNIPAQUE 350 is indicated for various radiographic imaging procedures, including oral administration for gastrointestinal (GI) tract imaging and intravenous administration for procedures such as aortography and selective visceral arteriography[2][4].

• Gastrointestinal Imaging: Studies have shown that OMNIPAQUE 350 provides comparable or significantly better images of diagnostic quality compared to other contrast agents like gastrografin 370[2].
• Pediatric Use: It is also indicated for oral administration in children for CT scans of the abdomen and pelvis, often in conjunction with intravenous OMNIPAQUE 240 or 300[2].

Market Performance

The market performance of OMNIPAQUE 350 can be gauged through its adoption rates, competitive landscape, and the overall demand for contrast agents.

• Competitive Landscape: OMNIPAQUE 350 competes with other contrast agents, but its efficacy and safety profile have positioned it as a preferred choice in many clinical settings[2].
• Adoption Rates: The drug's use in both adult and pediatric populations, along with its versatility in various imaging procedures, contributes to its strong market presence.

Financial Trajectory

To analyze the financial trajectory of OMNIPAQUE 350, we need to consider the broader financial health of its manufacturer and the pharmaceutical industry trends.

Manufacturer's Financial Health

OMNIPAQUE is manufactured by GE Healthcare, a division of General Electric. However, the financial data for GE Healthcare is often integrated into the overall financial reports of General Electric.

• Revenue and Profitability: While specific financial data for OMNIPAQUE 350 is not publicly disclosed, the overall revenue and profitability of GE Healthcare can provide insights. GE Healthcare has been a significant contributor to General Electric's revenue, with a focus on innovative medical technologies and pharmaceuticals[3].

Pharmaceutical Industry Trends

The pharmaceutical industry is driven by innovation, regulatory approvals, and market demand.

• Innovation and R&D: The development and approval of new contrast agents and imaging technologies can impact the market dynamics of existing products like OMNIPAQUE 350. However, its established position and continuous use in clinical practices suggest a stable market presence[3].
• Regulatory Approvals: OMNIPAQUE 350 has undergone rigorous clinical trials and has been approved for various indications, which supports its continued use and financial stability[2][4].

Pricing and Cost Considerations

The pricing of OMNIPAQUE 350 is influenced by several factors, including production costs, market demand, and regulatory environments.

• Production Costs: The cost of producing OMNIPAQUE 350 involves the expense of iohexol, other ingredients like tromethamine and edetate calcium disodium, and the sterilization process[1][4].
• Market Demand: The demand for high-quality contrast agents in radiographic imaging drives the pricing strategy. OMNIPAQUE 350's superior diagnostic quality and safety profile justify its market pricing[2].

Safety and Adverse Reactions

While financial performance is crucial, the safety profile of OMNIPAQUE 350 also impacts its market dynamics.

• Adverse Reactions: Common adverse reactions include headaches, pain, nausea, vomiting, and dizziness. Serious reactions such as contrast-induced acute kidney injury and cardiovascular adverse reactions can occur, necessitating careful patient monitoring and dose minimization[5].

Market Expansion and Growth Opportunities

The growth trajectory of OMNIPAQUE 350 is tied to the expanding need for diagnostic imaging and the increasing prevalence of conditions requiring such procedures.

• Global Health Trends: The rising incidence of gastrointestinal disorders and the need for precise diagnostic tools drive the demand for contrast agents like OMNIPAQUE 350.
• Emerging Markets: Expansion into emerging markets, where access to advanced diagnostic imaging is increasing, presents significant growth opportunities for OMNIPAQUE 350.

Regulatory Environment

Regulatory approvals and compliance are critical for the continued market presence of OMNIPAQUE 350.

• Clinical Trials and Approvals: The drug has been supported by multiple clinical trials demonstrating its safety and efficacy, which has led to regulatory approvals in various jurisdictions[2][4].

Conclusion

OMNIPAQUE 350's market dynamics are characterized by its strong clinical indications, competitive market position, and the broader financial health of its manufacturer. The drug's efficacy, safety profile, and regulatory approvals ensure its continued use and financial stability.

Key Takeaways

• Strong Clinical Indications: OMNIPAQUE 350 is indicated for various radiographic imaging procedures, including GI tract imaging and aortography.
• Competitive Market Position: It offers comparable or better diagnostic quality than other contrast agents.
• Financial Stability: The drug contributes to the overall revenue of its manufacturer, with a stable market presence.
• Safety Profile: While generally safe, it requires careful patient monitoring due to potential adverse reactions.
• Growth Opportunities: Expanding diagnostic needs and emerging markets present growth opportunities.

FAQs

1. What are the primary indications for OMNIPAQUE 350?

   • OMNIPAQUE 350 is indicated for oral administration for radiographic imaging of the GI tract and for intravenous administration in procedures like aortography and selective visceral arteriography.

2. How does OMNIPAQUE 350 compare to other contrast agents?

   • Studies have shown that OMNIPAQUE 350 provides comparable or significantly better images of diagnostic quality compared to other agents like gastrografin 370.

3. What are the common adverse reactions associated with OMNIPAQUE 350?

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

4. Is OMNIPAQUE 350 approved for pediatric use?

   • Yes, OMNIPAQUE 350 is approved for oral administration in children for CT scans of the abdomen and pelvis, often in conjunction with intravenous OMNIPAQUE 240 or 300.

5. What factors influence the pricing of OMNIPAQUE 350?

   • The pricing is influenced by production costs, market demand, and regulatory environments.

Sources

1. OMNIPAQUE™ (iohexol) Injection 140 180 240 300 350 mgI/mL - FDA Label[1].
2. Regulatory Decision Summary for Omnipaque - Health Canada[2].
3. Daiichi Sankyo Group Value Report 2018 - Daiichi Sankyo[3].
4. OMNIPAQUE™ (iohexol) Injection 300 350 - DailyMed[4].
5. OMNIPAQUE (iohexol) oral solution - FDA Label[5].