Iothalamate meglumine - Generic Drug Details

What are the generic sources for iothalamate meglumine and what is the scope of patent protection?

Iothalamate meglumine is the generic ingredient in five branded drugs marketed by Liebel-flarsheim and Mallinckrodt, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for iothalamate meglumine

US Patents:	0
Tradenames:	5
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	19
Patent Applications:	720
What excipients (inactive ingredients) are in iothalamate meglumine?	iothalamate meglumine excipients list
DailyMed Link:	iothalamate meglumine at DailyMed

Pharmacology for iothalamate meglumine

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

Medical Subject Heading (MeSH) Categories for iothalamate meglumine

Contrast Media

US Patents and Regulatory Information for iothalamate meglumine

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Liebel-flarsheim	CONRAY 30	iothalamate meglumine	INJECTABLE;INJECTION	016983-001	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Liebel-flarsheim	CONRAY 43	iothalamate meglumine	INJECTABLE;INJECTION	013295-002	Approved Prior to Jan 1, 1982		DISCN	Yes	No
Liebel-flarsheim	CONRAY	iothalamate meglumine	INJECTABLE;INJECTION	013295-001	Approved Prior to Jan 1, 1982		RX	Yes	Yes
Mallinckrodt	VASCORAY	iothalamate meglumine; iothalamate sodium	INJECTABLE;INJECTION	016783-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Liebel-flarsheim	CYSTO-CONRAY II	iothalamate meglumine	SOLUTION;INTRAVESICAL	017057-002	Approved Prior to Jan 1, 1982		RX	No	No

Iothalamate meglumine Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Iothalamate Meglumine

Introduction

Iothalamate meglumine, a versatile iodinated contrast agent, is widely used in medical imaging procedures such as CT scans, X-rays, and other diagnostic tests. This article delves into the market dynamics and financial trajectory of iothalamate meglumine, highlighting its current status, future projections, and key factors influencing its market.

Market Size and Growth

The global market for contrast agents, including iothalamate meglumine, is part of a broader pharmaceutical and diagnostic imaging sector. While specific data on iothalamate meglumine alone is not always segregated, the overall market for contrast agents is growing steadily.

• Current Market Size: The meglumine market, which includes iothalamate meglumine, was valued at USD 0.01 billion in 2023[1].
• Projected Growth: The market is expected to reach USD 0.02 billion by 2032, exhibiting a Compound Annual Growth Rate (CAGR) of 4% during this period[1].

Driving Factors

Several factors drive the demand for iothalamate meglumine:

• Diagnostic Needs: The increasing need for accurate diagnostic imaging in various medical conditions, such as cardiovascular diseases, neurological disorders, and gastrointestinal issues, fuels the demand for contrast agents like iothalamate meglumine[5].
• Technological Advancements: Advances in imaging technologies, including CT scans and MRI, enhance the utility and effectiveness of contrast agents, thereby driving their market[2].
• Aging Population: An aging global population with a higher incidence of chronic diseases contributes to the growing demand for diagnostic procedures and, consequently, contrast agents[5].

Key Players

The market for iothalamate meglumine is dominated by several key players:

• Merck: Known for its extensive portfolio of pharmaceuticals, including contrast agents.
• Tianma: A significant player in the production of meglumine-based products.
• Libang Healthcare Group: Active in the development and distribution of various pharmaceuticals, including contrast agents.
• New Hualian Pharm: Another major company involved in the production and marketing of meglumine-based products[1].

Product Applications

Iothalamate meglumine is used in a variety of medical imaging procedures:

• Diagnostic Imaging: It is used to help diagnose problems in the brain, back, heart, blood vessels, stomach, joints, pancreas, bladder, and other parts of the body during CT scans, X-rays, and other imaging tests[5].
• Contrast Enhancement: It enhances the contrast of structures or fluids within the body, making it easier to visualize and diagnose medical conditions.

Regulatory Environment

The regulatory landscape plays a crucial role in the market dynamics of iothalamate meglumine:

• FDA Approval: Iothalamate meglumine is approved by the FDA for use in various diagnostic procedures. Any changes in FDA regulations or approval processes can significantly impact the market[5].
• Safety and Efficacy: Continuous monitoring and reporting of safety and efficacy data are essential to maintain regulatory approval and public trust.

Challenges and Risks

Despite its growth potential, the market for iothalamate meglumine faces several challenges:

• Side Effects: The drug can cause serious side effects, including heart attack, stroke, blood clotting problems, and severe skin reactions. These risks necessitate careful patient monitoring and can impact market growth[5].
• Drug Shortages: Periodic shortages, such as the current shortage of iothalamate meglumine 17.2%, can disrupt supply chains and affect market stability[3].
• Competition: The market is competitive, with other contrast agents available, which can influence pricing and market share.

Financial Performance

The financial performance of the iothalamate meglumine market is closely tied to the overall demand for diagnostic imaging procedures and the availability of the drug:

• Revenue Growth: The projected growth to USD 0.02 billion by 2032 indicates a steady increase in revenue, driven by increasing diagnostic needs and technological advancements[1].
• Cost Considerations: The cost of production, distribution, and regulatory compliance can impact the profitability of companies involved in the market.

Future Outlook

The future outlook for iothalamate meglumine is positive, driven by several factors:

• Increasing Demand: The growing need for diagnostic imaging due to an aging population and rising incidence of chronic diseases will continue to drive demand[5].
• Technological Innovations: Advances in imaging technologies and contrast agent formulations will enhance the utility and safety of iothalamate meglumine, further boosting its market[2].

Key Takeaways

• The global meglumine market, including iothalamate meglumine, is expected to grow to USD 0.02 billion by 2032.
• The market is driven by diagnostic needs, technological advancements, and an aging population.
• Key players include Merck, Tianma, Libang Healthcare Group, and New Hualian Pharm.
• Iothalamate meglumine is used in various diagnostic imaging procedures and faces challenges such as side effects and drug shortages.

FAQs

1. What is iothalamate meglumine used for?

Iothalamate meglumine is used as an iodinated contrast agent to help diagnose or find problems in various parts of the body during medical imaging procedures such as CT scans and X-rays[5].

2. What are the potential side effects of iothalamate meglumine?

Potential side effects include heart attack, stroke, blood clotting problems, severe skin reactions, and other serious adverse reactions. It is crucial to monitor patients closely during and after administration[5].

3. Which companies are key players in the iothalamate meglumine market?

Key companies include Merck, Tianma, Libang Healthcare Group, and New Hualian Pharm[1].

4. What is the projected market size for iothalamate meglumine by 2032?

The global meglumine market, which includes iothalamate meglumine, is projected to reach USD 0.02 billion by 2032[1].

5. Why is there a current shortage of iothalamate meglumine 17.2%?

The current shortage of iothalamate meglumine 17.2% is due to various factors, including supply chain disruptions and manufacturing issues, which can impact the availability of the drug[3].

Cited Sources:

1. Business Research Insights: Meglumine Market Size, Share - [2024 To 2032] Growth Report.
2. Stanford Profiles: Curtis Langlotz.
3. ASHP: Drug Shortage Detail: Iothalamate Meglumine 17.2%.
4. GovInfo: Federal Register, Vol. 74, No. 27.
5. Mayo Clinic: Iothalamate meglumine (injection route).