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:	72
Clinical Trials:	26
Patent Applications:	6,356
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
National Cancer Institute (NCI)	PHASE2
Masonic Cancer Center, University of Minnesota	PHASE2
Chongqing Emergency Medical 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
Hainan Poly	IOPAMIDOL	iopamidol	INJECTABLE;INJECTION	217134-001	Sep 27, 2023	AP2	RX	No	No
Fresenius Kabi Usa	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074679-002	Apr 2, 1997		DISCN	No	No
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	018735-006	Jul 7, 1987	AP2	RX	Yes	Yes

Expired US Patents for IOPAMIDOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bracco	ISOVUE-370	iopamidol	INJECTABLE;INJECTION	020327-004	Oct 12, 1994
Bracco	ISOVUE-200	iopamidol	INJECTABLE;INJECTION	020327-001	Oct 12, 1994
Bracco	ISOVUE-M 200	iopamidol	INJECTABLE;INJECTION	018735-001	Dec 31, 1985

Market Dynamics and Financial Trajectory for Iopamidol

Last updated: July 28, 2025

Introduction

Iopamidol stands out as a widely utilized non-ionic iodinated contrast agent, primarily employed in diagnostic imaging modalities such as computed tomography (CT). Its pharmacological profile, favorable safety parameters, and expanding clinical indications underpin its prominent role in medical imaging markets. This report critically examines the underlying market dynamics and financial trajectory projections for Iopamidol, considering current trends, competitive pressures, regulatory factors, and technological innovations.

Market Overview

The global iodinated contrast media (ICM) market, estimated to reach USD 3.2 billion by 2025 at a compounded annual growth rate (CAGR) of approximately 5%, is significantly driven by the rising prevalence of cardiovascular and oncological conditions requiring advanced imaging diagnostics [1]. Iopamidol holds a substantial share within this niche, attributed to its high iodine concentration, low osmolality, and compatibility with an array of diagnostic procedures.

Key Market Players and Competition

Leading pharmaceutical firms such as Bracco Imaging, GE Healthcare, and Bayer dominate Iopamidol distribution, alongside regional players that foster competitive pricing. Bracco, the original patent holder, has leveraged intellectual property rights and strategic alliances to retain market leadership. Nonetheless, the emergence of generics and alternative contrast agents—such as gadolinium-based formulations for MRI—pose ongoing challenges.

Regulatory Environment

Regulatory agencies including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) enforce stringent approval and safety monitoring standards. Recent initiatives targeting contrast-induced nephropathy (CIN) and hypersensitivity have prompted reformulation efforts and enhanced post-market surveillance. Regulatory landscape stability fosters confidence among manufacturers and healthcare providers but necessitates continual compliance investment.

Market Dynamics Influencing Iopamidol's Trajectory

Demand Drivers

1. Growing Imaging Procedures: The global increase in CT scan utilization, driven by demand for minimally invasive diagnostics, propels Iopamidol sales. The rise in aging populations with chronic diseases further intensifies this demand.
2. Expanding Clinical Indications: Emerging uses in angiography, myelography, and cardiac imaging expand the clinical footprint.
3. Healthcare Infrastructure Development: Emerging markets are witnessing infrastructure investments, broadening access to advanced imaging, thereby expanding potential application markets for Iopamidol.

Supply Chain and Manufacturing Factors

The manufacturing of Iopamidol involves complex processes sensitive to raw material pricing and quality assurance standards. Supply chain disruptions, such as those experienced during the COVID-19 pandemic, highlighted vulnerabilities, emphasizing the need for resilient sourcing strategies.

Competitive and Technological Factors

While Iopamidol’s efficacy and safety record sustain demand, technological innovations threaten market saturation. New contrast agents with lower toxicity profiles, longer shelf life, or enhanced imaging capabilities are under development. For instance, efforts toward developing non-iodinated contrast agents or nanoparticle-based formulations could disrupt traditional ICM markets.

Pricing and Reimbursement Policies

Pricing strategies are influenced by competition, regulatory approval processes, and healthcare reimbursement frameworks. Payers in developed markets tend to favor cost-effective agents, prompting manufacturers to adopt value-based propositions. Reimbursement codes for contrast-enhanced imaging influence hospital procurement and usage volumes.

Regulatory and Safety Concerns

Incidences of contrast-related adverse events, including nephrotoxicity and allergic reactions, pose risks to market stability. Manufacturers are investing in reformulations and educational initiatives to mitigate these concerns. Regulatory agencies' increasing emphasis on post-market safety monitoring affects product lifecycle management and may slow adoption of newer formulations.

Financial Trajectory and Future Outlook

Revenue Projections

Based on historical data and market expansion forecasts, Iopamidol’s revenue is expected to grow at a CAGR of approximately 4-6% over the next five years. This growth is predicated on sustained demand in developed markets and emerging market expansion, despite competitive pressures from alternative agents.

Profitability and Investment Trends

Major manufacturers report stable profit margins due to high barriers to entry and established supply chains. However, investments in R&D for next-generation contrast agents and reformulations are increasing, reflecting strategic efforts to sustain market relevance. Focus areas include enhancing safety profiles, reducing injection doses, and enabling broader patient applicability.

Market Penetration Strategies

Companies are employing targeted marketing, clinician education, and post-market surveillance data to reinforce product positioning. Additionally, expanding indications and integrating contrast agents into integrated diagnostic platforms are increasing Iopamidol’s clinical utility.

Emerging Opportunities

The ongoing digital transformation in healthcare and personalized medicine creates avenues for tailored imaging agents. Collaborative development with technological firms for smart contrast formulations or companion diagnostics presents future growth prospects. Regulatory shifts favoring safer contrast agents could accelerate Iopamidol’s market penetration if product stewardship aligns with safety enhancements.

Impact of Regulatory and External Factors

Government initiatives aimed at reducing healthcare costs, coupled with regulatory incentives for safe contrast agents, influence investment and marketing strategies. Unexpected events, including global health crises and supply chain disruptions, could temporarily impact revenues but also stimulate innovation pipelines.

Conclusion

The market dynamics for Iopamidol remain cautiously optimistic, buoyed by increasing global imaging demands, clinical expansions, and technological innovations. Nonetheless, competition from emerging agents and regulatory scrutiny necessitate continuous adaptation. Manufacturers' focus on safety, efficiency, and integration into advanced diagnostic workflows will define the financial trajectory in the coming years.

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Key Takeaways

• Growth Drivers: Rising use of CT imaging and expanding clinical indications underpin sustained demand for Iopamidol.
• Competitive Landscape: Dominated by established players with ongoing innovation and reformulation strategies to address safety concerns.
• Regulatory Impact: Emphasizes safety profiles and post-market surveillance, creating both compliance challenges and innovation opportunities.
• Financial Outlook: Moderate growth trajectory with a CAGR of 4-6%, contingent upon demand stability and competitive innovation.
• Strategic Focus: Enhancing safety, expanding indications, and integrating technological advancements are critical for maintaining market share.

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FAQs

Q1: How does Iopamidol compare to other contrast agents in terms of safety?
A: Iopamidol's low osmolality and ionic nature confer a favorable safety profile, with reduced incidences of adverse reactions compared to older high-osmolar contrast agents. Nevertheless, hypersensitivity and nephrotoxicity risks persist, especially in vulnerable populations.

Q2: What are the primary factors limiting Iopamidol’s market growth?
A: Competition from newer contrast agents with improved safety and imaging capabilities, regulatory scrutiny on adverse effects, and the rise of alternative imaging modalities like MRI limit its expansion.

Q3: Are there regional differences affecting Iopamidol's market penetration?
A: Yes. Developed markets benefit from higher adoption rates due to advanced healthcare infrastructure and regulatory approval, while emerging markets exhibit growth potential driven by expanding access but face challenges related to regulatory processes and economic constraints.

Q4: What innovations are emerging to replace or supplement Iopamidol?
A: Developments include gadolinium-based agents for MRI, nanoparticle contrast materials, and non-iodinated agents that aim for enhanced safety and imaging efficiency.

Q5: How have recent regulatory policies impacted Iopamidol’s market?
A: Stricter safety and post-market surveillance regulations have increased compliance costs but also driven product reformulation and safety improvements, ensuring sustained market relevance.

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Sources:
[1] MarketsandMarkets, “Contrast Media Market by Product, Application, Route of Administration, and Region — Global Forecast to 2025,” 2021.