VISIPAQUE 320 Drug Patent Profile

Which patents cover Visipaque 320, and what generic alternatives are available?

Visipaque 320 is a drug marketed by Ge Healthcare and is included in two NDAs.

The generic ingredient in VISIPAQUE 320 is iodixanol. There are two drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the iodixanol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Visipaque 320

A generic version of VISIPAQUE 320 was approved as iodixanol by HENGRUI PHARMA on May 19^th, 2022.

Summary for VISIPAQUE 320

US Patents:	0
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	31
Patent Applications:	4,034
DailyMed Link:	VISIPAQUE 320 at DailyMed

Recent Clinical Trials for VISIPAQUE 320

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

Sponsor	Phase
Institute of Liver and Biliary Sciences, India	N/A
Guerbet	Phase 1
University of Washington	Phase 1

See all VISIPAQUE 320 clinical trials

Pharmacology for VISIPAQUE 320

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

US Patents and Regulatory Information for VISIPAQUE 320

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	AP	RX	Yes	Yes
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997		RX	No	No

Expired US Patents for VISIPAQUE 320

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997

International Patents for VISIPAQUE 320

See the table below for patents covering VISIPAQUE 320 around the world.

Country	Patent Number	Title	Estimated Expiration
Austria	20733
Belgium	877443
Jordan	1619
Luxembourg	88639

Supplementary Protection Certificates for VISIPAQUE 320

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0108638	97C0101	Belgium		PRODUCT NAME: IODIXANOL; NAT. REGISTRATION NO/DATE: 914 IS 204 F 12 19970325; FIRST REGISTRATION: SE 11758 19930205
0108638	SPC/GB93/150	United Kingdom		SPC/GB93/150, 20031107, EXPIRES: 20080330

VISIPAQUE 320 Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VISIPAQUE 320

Introduction

VISIPAQUE 320, an iodixanol-based non-ionic radiographic contrast medium, is widely used in various medical imaging procedures. Understanding its market dynamics and financial trajectory is crucial for stakeholders in the healthcare and pharmaceutical industries.

Market Overview

The contrast media market, which includes products like VISIPAQUE 320, is experiencing significant growth driven by several key factors.

Growing Demand for Diagnostic Imaging

The increasing prevalence of chronic diseases such as cancer and cardiovascular conditions is driving the demand for advanced diagnostic imaging techniques like CT scans and angiography. VISIPAQUE 320, with its high-quality imaging capabilities, is a preferred choice for these procedures[4].

Segmentation and Market Share

The Canada contrast media market, for instance, was estimated at USD 187.60 million in 2023, with the X-ray/Computed Tomography (CT) segment holding the largest share of 64.4%. VISIPAQUE 320, being a key product in this segment, contributes significantly to this market share[4].

Competitive Landscape

The market for contrast media is highly competitive, with major players such as GE HealthCare, Bayer AG, Guerbet, Lantheus Holdings, Inc., Bracco, and others. GE HealthCare, the manufacturer of VISIPAQUE 320, holds a significant position in this competitive landscape due to its extensive product portfolio and innovative technologies[4].

Growth Drivers

Several factors are driving the growth of the market for VISIPAQUE 320:

Increasing Prevalence of Chronic Diseases

The rising prevalence of chronic diseases such as cardiovascular disorders and cancer is increasing the demand for diagnostic imaging procedures, thereby driving the demand for contrast agents like VISIPAQUE 320[4].

Advancements in Diagnostic Imaging

Advancements in diagnostic imaging technologies, such as coronary angiography and CT scanning, are enhancing the diagnostic accuracy and efficiency of procedures, further boosting the demand for high-quality contrast agents[3].

Aging Population

An aging population is another significant factor contributing to the growth of the contrast media market. Older populations are more likely to require diagnostic imaging procedures, which in turn increases the demand for products like VISIPAQUE 320[4].

Financial Trajectory

The financial trajectory of VISIPAQUE 320 is closely tied to the overall growth of the contrast media market.

Market Size and Growth Rate

The Canada contrast media market is projected to grow at a compound annual growth rate (CAGR) of 7.2% from 2024 to 2030, reaching USD 300.15 million by 2030. Given its significant market share, VISIPAQUE 320 is expected to contribute substantially to this growth[4].

Revenue and Pricing

The pricing of VISIPAQUE 320 varies depending on the formulation and packaging. For example, the cost of VISIPAQUE 320 mg/ml in a vial is approximately USD 1.23 per ml. These pricing dynamics, along with the increasing demand, are expected to drive revenue growth for the product[5].

Strategic Developments and Innovations

Companies like GE HealthCare are continuously innovating and expanding their product lines to meet the evolving needs of the market.

New Product Developments and Approvals

Recent approvals and innovations, such as the approval of new contrast agents and imaging technologies, are expected to further propel the market growth. For instance, the approval of DEFINITY (Perflutren Lipid Microsphere) for pediatric patients with suboptimal echocardiograms highlights the ongoing efforts to expand the application of contrast media[4].

Challenges and Considerations

Despite the positive growth trajectory, there are several challenges and considerations that impact the market dynamics of VISIPAQUE 320.

Contraindications and Interactions

VISIPAQUE 320 has specific contraindications, such as intrathecal use, and interactions with other medications, which need to be carefully managed to ensure patient safety. These factors can influence prescribing patterns and market demand[2].

Regulatory Environment

The regulatory environment plays a crucial role in the approval and marketing of contrast media. Changes in regulatory policies or the introduction of new guidelines can impact the market dynamics of VISIPAQUE 320[4].

Key Takeaways

• Growing Demand: The increasing prevalence of chronic diseases and advancements in diagnostic imaging are driving the demand for VISIPAQUE 320.
• Competitive Market: The contrast media market is highly competitive, with GE HealthCare holding a significant position.
• Financial Growth: The market is projected to grow at a CAGR of 7.2% from 2024 to 2030, with VISIPAQUE 320 contributing substantially to this growth.
• Innovations and Approvals: Continuous innovations and new product approvals are expected to further drive market growth.
• Challenges: Contraindications, interactions, and regulatory considerations need to be managed carefully.

FAQs

1. What is VISIPAQUE 320 used for? VISIPAQUE 320 is used for various diagnostic imaging procedures, including visualization of the aorta and its branches, CT scanning of the head and body, excretory urography, and venography[1][2].

2. What are the key growth drivers for the VISIPAQUE 320 market? The key growth drivers include the increasing prevalence of chronic diseases, advancements in diagnostic imaging technologies, and an aging population[4].

3. Who are the major competitors in the contrast media market? Major competitors include GE HealthCare, Bayer AG, Guerbet, Lantheus Holdings, Inc., Bracco, and others[4].

4. What is the projected growth rate of the Canada contrast media market? The Canada contrast media market is projected to grow at a CAGR of 7.2% from 2024 to 2030[4].

5. What are some of the contraindications and interactions associated with VISIPAQUE 320? VISIPAQUE 320 is contraindicated for intrathecal use and may interact with other medications such as metformin and cholecystographic agents, among others[2].

Sources

1. Product Monograph VISIPAQUE (iodixanol injection USP) - Health Canada[1]
2. VISIPAQUE 320 Prescription & Dosage Information - MPR[2]
3. Clinical Review Karen Bleich NDA 020351 Supplement 44 - FDA[3]
4. Canada Contrast Media Market Size & Share Report, 2030 - Grand View Research[4]
5. Iodixanol: Uses, Interactions, Mechanism of Action - DrugBank Online[5]