IODOXAMATE MEGLUMINE - Generic Drug Details

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

Iodoxamate meglumine is the generic ingredient in one branded drug marketed by Bracco and is included in two NDAs. Additional information is available in the individual branded drug profile pages.

Summary for IODOXAMATE MEGLUMINE

US Patents:	0
Tradenames:	1
Applicants:	1
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	5
DailyMed Link:	IODOXAMATE MEGLUMINE at DailyMed

US Patents and Regulatory Information for IODOXAMATE MEGLUMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bracco	CHOLOVUE	iodoxamate meglumine	INJECTABLE;INJECTION	018076-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Bracco	CHOLOVUE	iodoxamate meglumine	INJECTABLE;INJECTION	018077-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Expired US Patents for IODOXAMATE MEGLUMINE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	CHOLOVUE	iodoxamate meglumine	INJECTABLE;INJECTION	018077-001	Approved Prior to Jan 1, 1982
Bracco	CHOLOVUE	iodoxamate meglumine	INJECTABLE;INJECTION	018076-001	Approved Prior to Jan 1, 1982

Market Dynamics and Financial Trajectory for Iodoxamate Meglumine

Introduction
Iodoxamate meglumine, a radiopaque contrast agent primarily utilized in angiography, myelography, and other diagnostic imaging procedures, holds a specialized position within the pharmaceutical and medical device sectors. As a chemical compound featuring iodine for radiopacity, its demand is closely linked to advancements in medical imaging technology, regulatory landscapes, and the evolving needs for diagnostic accuracy. This analysis explores market dynamics and the financial trajectory of iodoxamate meglumine, emphasizing key drivers, competitive landscape, regulatory factors, and future growth prospects.

Market Overview
Iodoxamate meglumine belongs to the broader class of iodine-based contrast agents (IBCA), distinguished by their safety profile and diagnostic efficacy. The global diagnostic imaging market, estimated at over USD 40 billion in 2022, drives the demand for contrast agents, with iodine compounds comprising a substantial share due to their high contrast enhancement capabilities. Despite competition from other classes, such as gadolinium-based agents for MRI and microbubble agents for ultrasound, iodine contrast media remain essential in angiography and digital subtraction angiography (DSA).

Market Drivers

1. Growing Prevalence of Cardiovascular Diseases
   Rising cardiovascular disease (CVD) incidence globally propels demand for detailed vascular imaging. Contrast agents like iodoxamate meglumine are integral to catheter-based procedures, supporting early diagnosis and intervention. The World Health Organization reports CVD remains the leading cause of death worldwide, with an increasing burden in low- and middle-income countries (LMICs), augmenting demand for accessible diagnostic solutions.

2. Advancements in Imaging Technologies
   Innovations in digital angiography, computed tomography (CT), and fluoroscopy systems demand high-quality contrast agents. Increased adoption of minimally invasive procedures, such as endovascular therapy for aneurysms, further amplifies the need for reliable contrast media. Moreover, automation and dose reduction features in modern imaging equipment promote the use of agents like iodoxamate meglumine that offer optimized contrast enhancement with minimal adverse effects.

3. Aging Population and Chronic Disease Burden
   The aging demographic globally expands the pool of patients requiring diagnostic imaging. Elderly populations are more likely to suffer from conditions necessitating contrast-enhanced scans, bolstering consumption of agents such as iodoxamate meglumine.

4. Regulatory and Patent Dynamics
   While many iodine contrast agents are off-patent or have expiring patents, this facilitates market entry and competitive pricing, encouraging widespread utilization. New formulations with improved safety profiles or reduced adverse reactions also stimulate market expansion.

Market Challenges

1. Safety and Side Effect Concerns
   Potential nephrotoxicity, allergic reactions, and thyroid effects associated with iodine-based contrast media curtail overuse, especially in patients with compromised renal function. Awareness of contrast-induced nephropathy (CIN) necessitates cautious application, influencing prescribing patterns and demand stability.

2. Availability of Alternatives
   Gadolinium-based agents and non-ion contrast media are expanding alternatives, especially in MRI diagnostics, which may limit iodine contrast agents’ growth in certain segments.

3. Stringent Regulatory Standards
   Increasing scrutiny from agencies such as the FDA and EMA imposes rigorous safety and efficacy requirements, potentially delaying approvals for new formulations and influencing pricing strategies.

Competitive Landscape

Major players involved in the production and distribution of iodine contrast agents include Guerbet, Lantheus Medical Imaging, and Bracco Diagnostics. Guerbet, with a portfolio including ioxaglate and iohexol, is a significant player, while Lantheus specializes in contrast media and imaging solutions. The market also encompasses generics and regional manufacturers, which exert competitive pressure through price competition.

Financial Trajectory and Market Projections

The global iodine contrast media market, driven significantly by agents like iodoxamate meglumine, is projected to grow at a compound annual growth rate (CAGR) of approximately 4-6% through 2030, reaching an estimated USD 6-8 billion. Several factors underpin this trajectory:

• Expanding Diagnostic Procedures: As imaging procedures grow in volume and complexity, the demand for high-contrast agents remains strong.
• Emerging Markets: Increasing healthcare infrastructure development and rising awareness in Asia-Pacific, Latin America, and Africa contribute substantially to the market growth. For instance, India’s diagnostic imaging market is expected to grow at a CAGR of over 8%, fostering demand for contrast media.
• Innovation and New Formulations: Efforts to develop lower-osmolar, iso-osmolar, and safer contrast agents improve safety profiles, expanding patient eligibility and usage scope. Pharmaceutical companies investing in R&D will influence market availability and competitive positioning.

Pricing and Profitability Considerations

Pricing strategies for iodoxamate meglumine fluctuate based on formulation, regional regulatory approval, and competitive dynamics. As patent protection diminishes, generic manufacturers enter the market, exerting downward pressure on prices. Nonetheless, high-volume demand, especially in hospitals and outpatient centers, sustains profitability for market leaders. Margin preservation hinges on production efficiency, safety profile enhancements, and differentiated formulations.

Regulatory Outlook and Market Entry Strategies

The regulatory environment remains pivotal. Fast-track approvals for new formulations and clear safety profiles facilitate market entry. Companies that effectively navigate the approval process and establish strong relationships with healthcare providers will capitalize on the projected growth. Conversely, delays due to safety concerns or regulatory barriers can impede financial performance.

Future Opportunities

• Personalized Imaging Solutions: Integration with AI-driven imaging analysis and tailored contrast protocols could enhance utility and revenue streams.
• Nanotechnology: Emerging research focuses on nanoparticle-based contrast agents, offering potentially superior safety and efficacy, representing future investment avenues.
• Expanding Indications: Broader use cases in interventional radiology, oncologic imaging, and interventional cardiac procedures will contribute to sustained demand.

Key Takeaways

• The demand for iodoxamate meglumine remains closely tethered to technological advances in imaging, demographic trends, and cardiovascular disease prevalence.
• Market growth is expected at 4-6% CAGR through 2030, propelled by emerging markets, innovation, and expanding indications.
• Price competition due to generic entries and safety profile improvements influence profitability, emphasizing the need for strategic differentiation.
• Regulatory pathways are complex; proactive engagement enhances market access and financial returns.
• Opportunities in personalized healthcare and nanotechnology present significant future revenue prospects.

FAQs

1. What factors most influence the demand for iodoxamate meglumine globally?
   The primary drivers include the rise in cardiovascular and chronic diseases, technological advances in imaging, aging populations, and expanding healthcare infrastructure, particularly in emerging markets.

2. How does regulatory scrutiny impact the market for iodine contrast agents?
   Stringent safety and efficacy standards can delay product approvals, influence pricing strategies, and necessitate ongoing safety evaluations, all of which directly affect market growth and profitability.

3. What are the main competitive challenges faced by manufacturers of iodoxamate meglumine?
   Challenges encompass safety concerns related to adverse reactions, competition from alternative imaging agents, price erosion due to generics, and regulatory complexities.

4. Are there emerging technological innovations that could disrupt the iodine contrast media market?
   Yes, nanotechnology-based contrast agents and AI-integrated imaging solutions could enhance safety, efficacy, and personalization, potentially reshaping demand patterns.

5. What strategies should pharmaceutical companies adopt to capitalize on future growth opportunities?
   Companies should focus on innovation—developing safer formulations and new indications—navigate regulatory pathways effectively, foster strategic partnerships, and penetrate emerging markets through tailored offerings.

References

Last updated: July 29, 2025

[1] Grand View Research, "Iodine Contrast Media Market Size, Share & Trends, Report, 2022."
[2] World Health Organization, " Cardiovascular Diseases Factsheet," 2022.
[3] MarketsandMarkets, "Diagnostic Imaging Market by Modality and Geography," 2022.
[4] Statista, "Global Market Share of Iodine-Based Contrast Agents," 2022.
[5] U.S. Food and Drug Administration (FDA), "Safety Guidance for Contrast Agents," 2021.