Iopamidol - Generic Drug Details

What are the generic drug sources for iopamidol and what is the scope of patent protection?

Iopamidol is the generic ingredient in eighteen branded drugs marketed by Baxter Hlthcare, Hainan Poly, Hospira, Cook Imaging, Fresenius Kabi Usa, Abbvie, Bracco, and Sanochemia Corp Usa, and is included in fourteen NDAs. Additional information is available in the individual branded drug profile pages.

There are eleven drug master file entries for iopamidol. Three suppliers are listed for this compound.

Summary for iopamidol

US Patents:	0
Tradenames:	18
Applicants:	8
NDAs:	14
Drug Master File Entries:	11
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	25
Patent Applications:	5,858
What excipients (inactive ingredients) are in iopamidol?	iopamidol excipients list
DailyMed Link:	iopamidol at DailyMed

Recent Clinical Trials for iopamidol

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

Sponsor	Phase
Chongqing Emergency Medical Center	N/A
Army Medical Center of PLA	N/A
M.D. Anderson Cancer Center	N/A

See all iopamidol clinical trials

Pharmacology for iopamidol

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

Medical Subject Heading (MeSH) Categories for iopamidol

Contrast Media

Anatomical Therapeutic Chemical (ATC) Classes for iopamidol

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 iopamidol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074898-003	Dec 30, 1997		DISCN	No	No
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	020327-004	Oct 12, 1994		RX	Yes	Yes
Hainan Poly	IOPAMIDOL	iopamidol	INJECTABLE;INJECTION	215382-001	Feb 27, 2023	AP1	RX	No	No
Sanochemia Corp Usa	SCANLUX-300	iopamidol	INJECTABLE;INJECTION	090394-001	Jun 18, 2010		DISCN	No	No

Expired US Patents for iopamidol

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-M 200	iopamidol	INJECTABLE;INJECTION	018735-001	Dec 31, 1985	4,001,323
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	020327-001	Oct 12, 1994	4,001,323
Bracco	ISOVUE-300	iopamidol	INJECTABLE;INJECTION	020327-003	Oct 12, 1994	4,001,323
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	018735-003	Dec 31, 1985	4,001,323

Market Dynamics and Financial Trajectory for Iopamidol

Introduction to Iopamidol

Iopamidol is a nonionic, low-osmolar contrast agent widely used in diagnostic imaging, particularly for angiography and computed tomography (CT) scans. Developed by Bracco, it is known for its safety profile and effectiveness in visualizing internal structures of the body[3].

Market Size and Forecast

The global iopamidol injection market is anticipated to experience significant growth over the forecast period from 2023 to 2031. The market size is expected to increase at a Compound Annual Growth Rate (CAGR) of 3 to 5 percent, driven by the increasing demand for diagnostic imaging procedures and advancements in medical technology[1][4].

Segmentation of the Market

The iopamidol injection market is segmented based on several key factors:

By Application

• Hospitals: These are the primary users of iopamidol, given the high volume of diagnostic procedures conducted in these settings.
• Clinics: Smaller clinics also utilize iopamidol, though to a lesser extent compared to hospitals[1].

By Product

• 9 g I/ 30 mL: This concentration is commonly used for various diagnostic procedures.
• 11.1 g I/ 30 mL: Another widely used concentration, particularly for more detailed imaging needs[1].

By Geography

• North America: A significant market due to advanced healthcare infrastructure and high demand for diagnostic imaging.
• Europe: Another major market with a strong focus on healthcare and diagnostic technologies.
• Asia-Pacific: This region is expected to grow rapidly due to increasing healthcare spending and technological advancements.
• South America and Middle-East & Africa: These regions also contribute to the market growth, though at a slower pace compared to North America and Europe[1].

Market Drivers

Several factors are driving the growth of the iopamidol injection market:

Increasing Demand for Diagnostic Imaging

The rising incidence of cardiovascular diseases and other conditions requiring diagnostic imaging is a key driver. Iopamidol's effectiveness in angiography and CT scans makes it a preferred choice for these procedures[2][3].

Technological Advancements

Advancements in medical imaging technologies, such as improved CT scanners and angiography equipment, enhance the utility and demand for contrast agents like iopamidol[4].

Safety and Efficacy

Iopamidol's low osmolarity and nonionic properties reduce the risk of adverse events compared to other contrast agents, making it a safer option for patients. Studies have shown that iopamidol results in significantly fewer adverse events than other agents like diatrizoate[2].

Market Restraints

Despite the growth potential, there are several restraints to consider:

High Cost

The use of iopamidol, while safer, is more expensive than some other contrast agents. This higher cost can be a barrier, especially in regions with limited healthcare budgets[2].

Regulatory Challenges

Stringent regulatory requirements and the need for continuous compliance can pose challenges for manufacturers and distributors of iopamidol[1].

Competitive Landscape

The iopamidol injection market is competitive, with several key players:

Major Players

• Bracco Imaging: The developer of iopamidol and a leading player in the contrast agent market.
• Sanochemia: Known for its range of diagnostic imaging agents.
• Consentis: Another significant player with a focus on diagnostic solutions.
• Bayer, Takeda, Fuji Pharma, Hikari Pharmaceutical, BeiLu Pharma: These companies also have a substantial presence in the market[1].

Financial Performance and Projections

The financial performance of the iopamidol injection market is robust and expected to continue growing:

Revenue Projections

The market is projected to increase in value from its current estimated valuation, with a CAGR of 3 to 5 percent from 2023 to 2031. This growth is driven by the increasing demand for diagnostic imaging and the expanding healthcare infrastructure in various regions[1][4].

Cost Analysis

While iopamidol is more expensive than some other contrast agents, its lower rate of adverse events can lead to overall cost savings in terms of reduced treatment costs for complications. However, the initial cost of the agent remains a significant factor in the financial analysis[2].

Pharmacokinetics and Clinical Use

Understanding the pharmacokinetics of iopamidol is crucial for its effective use:

Distribution and Elimination

Iopamidol is distributed between the circulating blood volume and other extracellular fluid, with no significant deposition in tissues. It is excreted mainly through the kidneys, and its elimination half-life is approximately two hours in patients with normal renal function[5].

Clinical Applications

Iopamidol is used for various diagnostic imaging procedures, including angiography and CT scans. It enhances the visualization of internal structures by increasing x-ray absorption, making it particularly useful for detecting tumors and other abnormalities[3][5].

Key Takeaways

• The iopamidol injection market is expected to grow at a CAGR of 3 to 5 percent from 2023 to 2031.
• The market is driven by increasing demand for diagnostic imaging and technological advancements.
• Iopamidol's safety profile and efficacy are significant advantages, though its higher cost is a restraint.
• Major players like Bracco Imaging and others dominate the market.
• The financial performance is robust, with revenue projections indicating continued growth.

FAQs

Q: What is iopamidol used for?

A: Iopamidol is a diagnostic imaging agent used for angiography and computed tomography (CT) scans to visualize internal structures of the body.

Q: What are the key drivers of the iopamidol injection market?

A: The increasing demand for diagnostic imaging, technological advancements, and the safety and efficacy of iopamidol are key drivers.

Q: Which regions are expected to drive the growth of the iopamidol injection market?

A: North America, Europe, and the Asia-Pacific region are expected to be significant drivers of market growth.

Q: What are the main restraints to the iopamidol injection market?

A: The high cost of iopamidol and regulatory challenges are major restraints.

Q: Who are the major players in the iopamidol injection market?

A: Bracco Imaging, Sanochemia, Consentis, Bayer, Takeda, Fuji Pharma, Hikari Pharmaceutical, and BeiLu Pharma are among the key players.

Sources

1. Market Research Intellect: "Iopamidol Injection Sales Market Size And Forecast"
2. PubMed: "Randomized comparison of the cost and effectiveness of iopamidol and diatrizoate for cardiac angiography"
3. DrugBank: "Iopamidol: Uses, Interactions, Mechanism of Action"
4. News Channel Nebraska: "Iopamidol Injection Market Size 2024 by Recent Technological Advancements, Growth Drivers, Key Developments, and Strategies"
5. Drugs.com: "Iopamidol Injection: Package Insert / Prescribing Info"