IODIXANOL - Generic Drug Details

What are the generic drug sources for iodixanol and what is the scope of freedom to operate?

Iodixanol is the generic ingredient in three branded drugs marketed by Hengrui Pharma and Ge Healthcare, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for iodixanol. Two suppliers are listed for this compound.

Summary for IODIXANOL

US Patents:	0
Tradenames:	3
Applicants:	2
NDAs:	3
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	73
Clinical Trials:	37
Patent Applications:	6,822
What excipients (inactive ingredients) are in IODIXANOL?	IODIXANOL excipients list
DailyMed Link:	IODIXANOL at DailyMed

Recent Clinical Trials for IODIXANOL

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

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

See all IODIXANOL clinical trials

Pharmacology for IODIXANOL

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

Anatomical Therapeutic Chemical (ATC) Classes for IODIXANOL

V08AB	Watersoluble, nephrotropic, low osmolar X-ray contrast media
V08A	X-RAY CONTRAST MEDIA, IODINATED
V08	CONTRAST MEDIA
V	Various

US Patents and Regulatory Information for IODIXANOL

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	020808-002	Aug 29, 1997		RX	No	No
Hengrui Pharma	IODIXANOL	iodixanol	INJECTABLE;INJECTION	214271-002	May 19, 2022	AP	RX	No	No
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351-001	Mar 22, 1996	AP	RX	Yes	Yes
Hengrui Pharma	IODIXANOL	iodixanol	INJECTABLE;INJECTION	214271-001	May 19, 2022	AP	RX	No	No
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	AP	RX	Yes	Yes
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997		DISCN	No	No

Expired US Patents for IODIXANOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997	4,396,597
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	RE36418
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	4,396,597
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020351-001	Mar 22, 1996	4,278,654
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020351-002	Mar 22, 1996	4,278,654
Ge Healthcare	VISIPAQUE 270	iodixanol	INJECTABLE;INJECTION	020808-001	Aug 29, 1997	RE36418
Ge Healthcare	VISIPAQUE 320	iodixanol	INJECTABLE;INJECTION	020808-002	Aug 29, 1997	4,278,654

IODIXANOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Iodixanol

Introduction to Iodixanol

Iodixanol, a third-generation contrast agent, is widely used in medical imaging procedures such as cardiovascular angiography, cerebrovascular angiography, abdominal angiography, and various CT and MRI scans. Developed by Nycomed and now marketed by GE Healthcare as VISIPAQUE, iodixanol has gained significant traction globally, particularly in the Chinese market.

Market Entry and Growth in China

Iodixanol entered the Chinese market in 2001 and has since experienced substantial growth. The sales value of iodixanol in China increased significantly from 2016 to 2020, reaching approximately CNY1.49 billion in 2020, with a Compound Annual Growth Rate (CAGR) of 27% during this period[1].

Impact of COVID-19

The COVID-19 pandemic had a temporary but notable impact on the sales of iodixanol in China. The reduction in hospital operations due to the pandemic led to a slowdown in the growth rate of iodixanol sales. However, as the epidemic situation improved, the market is expected to recover and continue its growth trajectory from 2021 to 2025[1].

Competitive Landscape

The Chinese iodixanol market is dominated by several key manufacturers:

• GE Healthcare: As the original developer and marketer of VISIPAQUE, GE Healthcare holds a significant market share.
• Jiangsu Hengrui Medicine: Known for its product Huiyu, Jiangsu Hengrui is a major player in the Chinese market.
• Yangtze River Pharmaceutical Group: With its product Xiansu, this group is another significant competitor.
• Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd.: This company markets Qingliming, another popular iodixanol product.
• Beijing Beilu Pharmaceutical Co., Ltd.: Beijing Beilu's product, Dianchunning, also contributes to the market share[1].

Sales Value and Volume

The sales value and volume of iodixanol in China have shown a steady increase. Here are some key statistics:

• Sales Value: The overall sales value of iodixanol in China reached CNY1.49 billion in 2020, with a 1.52% year-over-year (YoY) increase[1].
• Sales Volume: The sales volume also saw significant growth, though the exact figures vary by region and manufacturer[1].

Pricing Dynamics

The prices of iodixanol in China vary by manufacturer and region. Here is a brief overview:

• Regional Pricing: Prices differ across different regions in China, reflecting local market conditions and competition.
• Manufacturer Pricing: Each major manufacturer has its own pricing strategy. For example, GE Healthcare's VISIPAQUE, Jiangsu Hengrui's Huiyu, and Yangtze River Pharmaceutical's Xiansu have different price points[1].

Market Expansion and Potential

The Chinese market for iodixanol is expected to expand due to several factors:

• Equipment Holding Volume: The holding volume of CT and MRI equipment in China is significantly lower than in developed countries like the U.S. and Japan. This gap presents a substantial opportunity for growth as the number of equipment installations increases[1].
• Market Demand: The demand for contrast agents is directly linked to the number of imaging procedures, which is expected to rise with the increasing availability of CT and MRI equipment[1].

Financial Trajectory

Historical Performance

• From 2016 to 2020, the sales value of iodixanol in China grew at a CAGR of 27%, indicating strong market demand and growth potential[1].

Future Prospects

• The market is expected to recover from the COVID-19 impact and continue growing from 2021 to 2025. The expansion of the market, driven by increasing equipment installations and rising demand for imaging procedures, will likely sustain this growth[1].

Global Market Outlook

• Globally, the iodixanol API market is projected to experience significant growth from 2023 to 2031. The market dynamics are driven by factors such as increasing demand for medical imaging, advancements in healthcare infrastructure, and the expansion of generic drug markets[4].

Key Factors Influencing Market Dynamics

Drivers

• Increasing Demand for Medical Imaging: The growing need for diagnostic imaging procedures drives the demand for contrast agents like iodixanol.
• Expansion of Healthcare Infrastructure: The installation of more CT and MRI equipment in China and other regions will increase the demand for iodixanol.
• Government Policies and Healthcare Reforms: Favorable healthcare policies and reforms can enhance access to medical imaging services, thereby boosting the market for iodixanol[1][4].

Constraints

• COVID-19 Pandemic: The pandemic temporarily reduced hospital operations and, consequently, the sales of iodixanol.
• Competition: The presence of multiple manufacturers can lead to competitive pricing and market share challenges.
• Regulatory Approvals: Changes in regulatory approvals or safety guidelines can impact the market dynamics[1][4].

Competitive Landscape Analysis

The competitive landscape of the iodixanol market in China is characterized by the presence of several major players. Here is a brief overview of the key competitors:

• Market Share: GE Healthcare, Jiangsu Hengrui Medicine, Yangtze River Pharmaceutical Group, Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd., and Beijing Beilu Pharmaceutical Co., Ltd. are the main players, each holding a significant market share based on sales value and volume[1].

Pricing Strategies

The pricing strategies of iodixanol manufacturers in China are influenced by several factors:

• Regional Market Conditions: Prices vary across different regions due to local market conditions and competition.
• Product Differentiation: Each manufacturer may differentiate its product through branding, quality, and service, which can influence pricing.
• Regulatory Environment: Pricing can be affected by regulatory policies and guidelines[1].

Regulatory Environment

Iodixanol is approved for various medical imaging procedures, including cardiovascular angiography, cerebrovascular angiography, and CT scans. Regulatory approvals and updates play a crucial role in shaping the market:

• U.S. Regulatory Actions: In the U.S., iodixanol (VISIPAQUE) has been approved for several indications since its initial approval in 1996. Regulatory updates and new indications can expand its market[3].

Pharmacokinetics and Safety

Iodixanol is known for its favorable pharmacokinetic profile:

• Isosmolar and Nonionic: Iodixanol is isosmolar to plasma, reducing the risk of osmotic effects.
• Rapid Excretion: It is predominantly renally excreted, with approximately 97% of the injected dose excreted unchanged in the urine within 24 hours[3].

Market Outlook 2021-2025

The Chinese iodixanol market is expected to continue its growth trajectory from 2021 to 2025, driven by:

• Recovery from COVID-19: As the pandemic's impact diminishes, hospital operations and imaging procedures are expected to increase.
• Market Expansion: The increasing installation of CT and MRI equipment will drive the demand for contrast agents like iodixanol[1].

Global Market Projections 2023-2031

Globally, the iodixanol API market is projected to experience significant growth:

• Market Size and Growth Rate: The market is expected to grow substantially, driven by increasing demand for medical imaging and advancements in healthcare infrastructure[4].

Key Takeaways

• Strong Growth Trajectory: The Chinese iodixanol market has shown a strong growth trajectory with a CAGR of 27% from 2016 to 2020.
• Recovery and Expansion: The market is expected to recover from the COVID-19 impact and expand further from 2021 to 2025.
• Global Market Potential: The global iodixanol API market is poised for significant growth from 2023 to 2031.
• Competitive Landscape: The market is competitive with several major players, each with its own pricing and market share strategies.
• Regulatory and Pharmacokinetic Favorability: Iodixanol's regulatory approvals and favorable pharmacokinetic profile support its market position.

FAQs

Q: What is iodixanol used for?

Iodixanol is used for various medical imaging procedures, including cardiovascular angiography, cerebrovascular angiography, abdominal angiography, and CT scans of the head and body[1][3].

Q: How did the COVID-19 pandemic affect the iodixanol market in China?

The COVID-19 pandemic temporarily reduced hospital operations, leading to a slowdown in the growth rate of iodixanol sales in China. However, the market is expected to recover as the pandemic's impact diminishes[1].

Q: Who are the main manufacturers of iodixanol in China?

The main manufacturers of iodixanol in China include GE Healthcare, Jiangsu Hengrui Medicine, Yangtze River Pharmaceutical Group, Nanjing Chia Tai Tianqing Pharmaceutical Co., Ltd., and Beijing Beilu Pharmaceutical Co., Ltd.[1].

Q: What are the key drivers of the iodixanol market?

Key drivers include increasing demand for medical imaging, expansion of healthcare infrastructure, and favorable government policies and healthcare reforms[1][4].

Q: What is the global market outlook for iodixanol from 2023 to 2031?

The global iodixanol API market is projected to experience significant growth, driven by increasing demand for medical imaging and advancements in healthcare infrastructure. The market is expected to expand substantially during this period[4].

Sources

1. Investigation Report on China's Iodixanol Market, 2016-2020 & 2021-2025 - ResearchAndMarkets.com
2. Capital Markets Day 2023 Presentation - Fresenius
3. Clinical Review Karen Bleich NDA 020351 Supplement 44 - FDA
4. Global Iodixanol API Market Size, Scope And Forecast Report - Market Research Intellect