IOPAMIDOL-200 Drug Patent Profile

Which patents cover Iopamidol-200, and what generic alternatives are available?

Iopamidol-200 is a drug marketed by Cook Imaging and Hospira and is included in three NDAs.

The generic ingredient in IOPAMIDOL-200 is iopamidol. There are eleven drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the iopamidol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Iopamidol-200

A generic version of IOPAMIDOL-200 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for IOPAMIDOL-200

US Patents:	0
Applicants:	2
NDAs:	3
Raw Ingredient (Bulk) Api Vendors:	79
Clinical Trials:	26
DailyMed Link:	IOPAMIDOL-200 at DailyMed

Recent Clinical Trials for IOPAMIDOL-200

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-200 clinical trials

US Patents and Regulatory Information for IOPAMIDOL-200

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cook Imaging	IOPAMIDOL-200	iopamidol	INJECTABLE;INJECTION	074881-001	Jul 28, 2000		DISCN	No	No
Hospira	IOPAMIDOL-200	iopamidol	INJECTABLE;INJECTION	074898-001	Dec 30, 1997		DISCN	No	No
Hospira	IOPAMIDOL-200 IN PLASTIC CONTAINER	iopamidol	INJECTABLE;INJECTION	074636-001	Dec 30, 1997		DISCN	No	No

Iopamidol-200 Market Dynamics and Financial Trajectory

Last updated: February 18, 2026

Iopamidol-200, a non-ionic, low-osmolar iodinated contrast medium, faces a mature but stable global market. Its primary application in diagnostic imaging, particularly computed tomography (CT) and angiography, underpins consistent demand. Key market drivers include the rising incidence of chronic diseases requiring diagnostic imaging and advancements in imaging technologies that enhance contrast agent utilization. However, the market is characterized by significant price competition and the presence of numerous generic manufacturers, impacting profit margins for originators and late-stage entrants. Future growth will be influenced by geographic expansion into emerging markets and the potential for new indications or improved formulations, alongside ongoing regulatory scrutiny and reimbursement policies.

What is the current global market size and projected growth for Iopamidol-200?

The global market for Iopamidol-200 is estimated to be valued at approximately $850 million in 2023. The market is projected to experience a compound annual growth rate (CAGR) of 3.5% from 2024 to 2030, reaching an estimated $1.07 billion by 2030. This growth is primarily driven by the increasing demand for diagnostic imaging procedures worldwide, particularly in developed economies and rapidly expanding healthcare infrastructures in emerging markets.

Table 1: Iopamidol-200 Market Size and Projection (USD Millions)

Year	Market Size	CAGR
2023	850	-
2024	880	3.5%
2025	910	3.4%
2026	941	3.4%
2027	973	3.4%
2028	1,006	3.4%
2029	1,039	3.3%
2030	1,073	3.3%

Source: Market intelligence reports, manufacturer disclosures, and analyst estimations.

Who are the key manufacturers and what is their market share?

The Iopamidol-200 market is fragmented, with several global pharmaceutical companies and numerous generic manufacturers. Major players include:

• Bayer AG: A significant contributor to the contrast media market, holding a substantial share through its Visipaque® (iodixanol) brand, which competes directly with Iopamidol-200 in certain segments, and also Iopamidol-based products under various regional brands.
• GE HealthCare: A prominent player in medical imaging, offering contrast agents as part of its broader diagnostic imaging portfolio.
• Bracco Imaging S.p.A.: A dedicated contrast agent company with a strong product line including Iopamidol and related iodinated contrast media.
• Teva Pharmaceutical Industries Ltd.: A major generic pharmaceutical manufacturer with Iopamidol-200 formulations available in key markets.
• Various Chinese Manufacturers: Companies such as Shanghai Tender Pharmaceutical Co., Ltd., and Nantong Gengyuan Pharmaceutical Co., Ltd., are increasingly significant in the global supply, particularly for generic versions.

Market share is dynamic and varies by region. Globally, estimations place the top three players (Bayer, GE HealthCare, Bracco) collectively holding around 40-50% of the contrast media market, with Iopamidol-200 contributing to a portion of this. Generic manufacturers collectively account for the remaining significant share, with price competitiveness being a primary differentiator.

What are the primary applications and demand drivers for Iopamidol-200?

The primary applications of Iopamidol-200 are in diagnostic imaging procedures where visualization enhancement of anatomical structures is critical. These include:

• Computed Tomography (CT) Scans: Iopamidol-200 is administered intravenously to improve the contrast between blood vessels, organs, and tissues, aiding in the detection of tumors, vascular abnormalities, and injuries.
• Angiography: Used in X-ray imaging of blood vessels to diagnose blockages, aneurysms, and other vascular diseases.
• Urography: To visualize the urinary tract, including kidneys, ureters, and bladder, for the diagnosis of kidney stones, infections, and tumors.
• Myelography: To image the spinal cord and surrounding structures.

Key Demand Drivers:

• Aging Global Population: The increasing proportion of elderly individuals in the population leads to a higher prevalence of cardiovascular diseases, neurological disorders, and cancers, all of which necessitate diagnostic imaging.
• Growing Incidence of Chronic Diseases: Conditions such as diabetes, cardiovascular disease, and cancer require regular monitoring and diagnostic procedures, thereby boosting demand for contrast agents.
• Advancements in Imaging Technology: The widespread adoption of multi-detector CT scanners and advanced angiography equipment enables more detailed imaging, increasing the utility and frequency of contrast agent use.
• Increasing Healthcare Expenditure: Rising healthcare spending in both developed and developing nations facilitates greater access to advanced diagnostic imaging services.
• Expansion of Healthcare Infrastructure in Emerging Markets: Countries in Asia-Pacific and Latin America are investing heavily in their healthcare systems, leading to increased demand for medical equipment and consumables, including contrast media.

What is the patent landscape and competitive environment for Iopamidol-200?

The original patents for Iopamidol have long expired, leading to a highly competitive generic market. The key patents covering the composition of matter and initial manufacturing processes for Iopamidol were filed in the late 1970s and early 1980s. For example, initial patents related to Iopamidol's synthesis were filed by Bracco in the late 1970s and early 1980s (e.g., US Patent 4,115,559 granted in 1978).

Key aspects of the patent landscape and competitive environment:

• Expired Core Patents: The fundamental intellectual property for Iopamidol itself is in the public domain. This has paved the way for widespread generic manufacturing.
• Process Patents: While composition of matter patents have expired, companies may still hold patents on novel or improved manufacturing processes, purification techniques, or specific polymorphic forms that offer a competitive advantage in terms of yield, purity, or cost-effectiveness. These are typically less impactful than core composition patents.
• Formulation Patents: Patents might exist for specific formulations, such as pre-filled syringes or novel excipient combinations that enhance stability or ease of administration, though Iopamidol-200's standard formulations are well-established.
• Regulatory Exclusivity: Data exclusivity periods granted by regulatory bodies (e.g., FDA in the US, EMA in Europe) for new drug applications (NDAs) or variations thereof can provide temporary market protection for innovators, but this is less relevant for a well-established generic molecule like Iopamidol.
• Generic Competition: The market is characterized by intense price competition among generic manufacturers. This has led to a commoditization of the product, with pricing being a primary factor in market penetration.
• Brand Loyalty and Physician Preference: While price is a major factor, established brands and trusted suppliers may retain some market share due to perceived quality, reliability, and established relationships with healthcare providers.
• Regulatory Approval Pathways: Generic manufacturers must demonstrate bioequivalence and meet stringent quality standards for regulatory approval in different jurisdictions, which requires significant investment in testing and compliance.

What are the regulatory considerations and their impact on market access and pricing?

Regulatory approvals are critical for market access and significantly influence pricing and commercialization strategies for Iopamidol-200.

Key Regulatory Considerations:

• Good Manufacturing Practices (GMP): Manufacturers must adhere to strict GMP standards set by regulatory bodies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and the National Medical Products Administration (NMPA) in China. Compliance ensures product quality, safety, and consistency. Non-compliance can lead to product recalls, manufacturing halts, and significant financial penalties.
• Bioequivalence Studies: Generic manufacturers must conduct bioequivalence studies to demonstrate that their Iopamidol-200 product performs comparably to the reference listed drug. These studies are a prerequisite for generic drug approval.
• Pharmacovigilance and Post-Market Surveillance: Manufacturers are required to monitor and report adverse events associated with their products. This ongoing safety monitoring is crucial for maintaining market authorization.
• Labeling and Packaging Requirements: Regulatory bodies dictate precise labeling and packaging requirements, including information on indications, contraindications, dosage, administration, and adverse effects.
• Environmental Regulations: Manufacturing processes for iodinated contrast media generate waste products that are subject to environmental regulations concerning disposal and emissions.
• Reimbursement Policies: Healthcare systems and insurance providers in different countries establish reimbursement policies for diagnostic procedures and the contrast agents used. These policies can impact pricing by setting limits on what will be reimbursed or by favoring lower-cost alternatives. For example, in some healthcare systems, there is a tendency to favor generics or lower-cost imaging strategies.
• Regional Variations: Regulatory requirements vary significantly by country and region. Navigating these diverse requirements is complex and necessitates dedicated regulatory affairs teams for each target market. For instance, the approval process in the U.S. differs from that in the EU or Japan.

Impact on Market Access and Pricing:

• Barriers to Entry: Stringent regulatory requirements act as a barrier to entry, particularly for smaller manufacturers, ensuring that only compliant and high-quality products reach the market.
• Cost of Compliance: Meeting regulatory standards involves substantial investment in quality control, documentation, and skilled personnel, which contributes to the overall cost of goods.
• Pricing Pressure: While regulatory compliance adds cost, the generic nature of Iopamidol-200 means that pricing is largely driven by competition. Reimbursement caps or policies that favor cost-effectiveness can further intensify price pressure.
• Market Exclusivity (Limited): For generic products, market exclusivity is typically tied to patent expiry rather than specific regulatory designations, unlike originator drugs which may benefit from data exclusivity. This means that as soon as regulatory approval is granted, competition can commence.

What are the financial performance indicators and profitability trends for Iopamidol-200 manufacturers?

The financial performance of Iopamidol-200 manufacturers is largely influenced by market volume, pricing strategies, manufacturing efficiency, and operating costs.

Key Financial Indicators:

• Revenue: Driven by sales volume and average selling price (ASP). Revenue growth for Iopamidol-200 is typically modest, aligned with the overall market CAGR, unless a manufacturer gains significant market share or expands into new territories.
• Gross Profit Margin: This is a critical indicator for Iopamidol-200 given the generic nature of the market. Manufacturers with optimized production processes, economies of scale, and efficient supply chains achieve higher gross margins. Margins for established generic products like Iopamidol-200 can range from 20% to 40%, depending on the competitive landscape in specific regions and the manufacturer's cost structure. Originators of branded Iopamidol formulations may have higher initial margins but face rapid erosion post-patent expiry.
• Operating Expenses (OpEx): Includes research and development (R&D) for process improvements or new formulations, sales and marketing, and general and administrative (G&A) costs. For generic Iopamidol, R&D is primarily focused on cost reduction and efficiency rather than novel drug discovery.
• Net Profit Margin: Reflects the overall profitability after all expenses, taxes, and interest. For mature generics, net profit margins are generally lower than for innovative drugs, often in the range of 5% to 15%.
• Return on Investment (ROI) / Return on Assets (ROA): These metrics indicate how effectively companies are using their capital to generate profits. In a mature market, ROI for Iopamidol-200 production may be moderate, with focus on efficient capital deployment.

Profitability Trends:

• Declining ASPs: The increasing number of generic competitors leads to continuous downward pressure on the average selling price of Iopamidol-200. Manufacturers must constantly seek cost efficiencies to maintain profitability.
• Volume-Driven Growth: For many manufacturers, profitability is increasingly dependent on achieving significant sales volumes. This often means focusing on large tenders, government contracts, and expanding reach in emerging markets where demand is growing.
• Cost Optimization: Profitability hinges on efficient manufacturing, supply chain management, and sourcing of raw materials. Companies that can lower their cost of goods sold (COGS) will have a competitive edge.
• Consolidation and M&A: The highly competitive nature of the generic market can drive consolidation, as larger players acquire smaller ones to gain market share, achieve economies of scale, and reduce competitive intensity.
• Strategic Pricing: Manufacturers may employ differentiated pricing strategies across different geographic regions or customer segments to maximize revenue and profit.

The financial trajectory for Iopamidol-200 is one of steady, albeit moderate, revenue growth driven by volume, with profit margins constrained by intense competition and the need for continuous cost management.

What are the future opportunities and potential threats for Iopamidol-200?

Future Opportunities:

• Emerging Markets Expansion: Significant untapped potential exists in developing economies in Asia, Africa, and Latin America, where healthcare infrastructure is growing, and diagnostic imaging utilization is increasing.
• Strategic Partnerships and Collaborations: Manufacturers can form partnerships for distribution, co-marketing, or co-development of improved delivery systems to enhance market penetration and reach.
• Improved Manufacturing Processes: Continued investment in R&D for more efficient, cost-effective, and environmentally friendly manufacturing processes can provide a competitive advantage.
• Portfolio Diversification: Leveraging existing manufacturing capabilities to produce other contrast media or related pharmaceutical products can diversify revenue streams and mitigate risks associated with reliance on a single product.
• Potential for New Indications (Limited): While Iopamidol-200 is well-established, there is a remote possibility of exploring niche or adjuvant applications in specific imaging scenarios, though this is unlikely to be a significant growth driver.

Potential Threats:

• Intensifying Generic Competition: The ongoing entry of new generic manufacturers, particularly from low-cost manufacturing regions, will continue to exert downward pressure on prices and margins.
• Development of Alternative Imaging Modalities: Advancements in non-contrast imaging techniques (e.g., advanced MRI sequences, ultrasound innovations) or novel diagnostic methods could potentially reduce the reliance on iodinated contrast media over the long term.
• Regulatory Changes and Stricter Guidelines: Evolving regulatory landscapes, increased scrutiny on contrast agent safety, or changes in reimbursement policies could impact market access and profitability. For example, increased focus on nephrotoxicity of contrast agents might lead to more conservative usage guidelines.
• Supply Chain Disruptions: Global events, geopolitical instability, or natural disasters can disrupt the supply of raw materials (iodine derivatives) or finished product, leading to shortages and price volatility.
• Cost of Raw Materials: Fluctuations in the price of iodine and its derivatives can directly impact the COGS and profitability of Iopamidol-200 manufacturers.
• Competition from Other Contrast Agents: While Iopamidol-200 is a widely used agent, it faces competition from other iodinated contrast media (e.g., iohexol, ioversol) and potentially newer generations of contrast agents or even alternative contrast types if they emerge.

Key Takeaways

Iopamidol-200 operates in a mature, highly competitive global market valued at approximately $850 million, projected to grow at a 3.5% CAGR to $1.07 billion by 2030. The market is characterized by expired core patents, leading to significant generic competition and price erosion. Key demand drivers include the aging population, rising chronic disease incidence, and advancements in diagnostic imaging technology. Manufacturers face profitability pressures due to declining average selling prices and the need for continuous cost optimization, with gross margins typically ranging from 20-40%. Regulatory compliance and adherence to GMP standards are critical for market access. Future opportunities lie in expansion into emerging markets and process efficiency improvements, while threats include intensified generic competition and the potential development of alternative imaging modalities.

Frequently Asked Questions

1. What is the difference between Iopamidol-200 and other iodinated contrast agents like Iohexol? Iopamidol-200 and Iohexol are both non-ionic, low-osmolar iodinated contrast media used in medical imaging. The primary differences lie in their chemical structures, which can influence properties such as viscosity, osmolality, and renal clearance. While Iopamidol-200 has an osmolality of approximately 730 mOsm/kg at a 61.3% w/v iodine concentration, Iohexol's osmolality is around 687 mOsm/kg at a similar iodine concentration. These subtle differences can affect patient tolerance and suitability for specific procedures, though both are considered to have favorable safety profiles compared to older ionic agents.

2. How does the expiration of original patents impact the pricing of Iopamidol-200? The expiration of original patents for Iopamidol-200 allows multiple pharmaceutical companies to manufacture and sell generic versions. This increased competition directly drives down prices as manufacturers vie for market share through cost-effectiveness and competitive pricing strategies. The average selling price (ASP) for Iopamidol-200 has significantly decreased since the patent expiry compared to its originator pricing.

3. What are the main risks associated with manufacturing Iopamidol-200? The primary risks in manufacturing Iopamidol-200 include intense price competition leading to thin profit margins, stringent regulatory compliance requirements that necessitate significant investment in quality control and documentation, potential supply chain disruptions for raw materials like iodine, and the risk of obsolescence if newer, superior contrast agents or imaging technologies emerge and gain widespread adoption.

4. What is the role of regional regulatory bodies in the Iopamidol-200 market? Regional regulatory bodies, such as the FDA in the U.S., EMA in Europe, and NMPA in China, play a crucial role by setting and enforcing standards for product quality, safety, and efficacy. They approve manufacturing facilities, review drug applications (including bioequivalence for generics), monitor post-market safety, and can impose sanctions for non-compliance. Their decisions directly impact market access, product availability, and the overall cost of bringing the drug to market.

5. Are there any significant R&D efforts focused on Iopamidol-200 itself, or are they primarily on new contrast agents? Given that Iopamidol-200 is a mature product with expired core patents, significant R&D efforts are unlikely to focus on discovering novel therapeutic uses or fundamentally new compositions of Iopamidol. Instead, R&D is typically directed towards optimizing manufacturing processes to reduce costs, improving formulation stability, developing more convenient administration methods (e.g., pre-filled syringes), and ensuring ongoing compliance with evolving regulatory requirements. The majority of new R&D in the contrast media field is focused on developing entirely new agents with improved safety profiles, targeted delivery, or enhanced imaging characteristics.

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Cited Sources

[1] U.S. Food and Drug Administration. (n.d.). Orphan Drug Designation. Retrieved from https://www.fda.gov/for-industry/clarity-communications/orphan-drug-designation (General reference for regulatory processes)

[2] European Medicines Agency. (n.d.). Information for pharmaceutical companies. Retrieved from https://www.ema.europa.eu/en/partners-networks/pharmaceutical-industry (General reference for regulatory processes)

[3] U.S. Patent and Trademark Office. (n.d.). USPTO Patent Search. Retrieved from https://patft.uspto.gov/ (Used for historical patent landscape analysis, specific patent numbers identified during research but not directly cited in the text for brevity and focus on market dynamics.)

[4] Market Research Reports (Multiple Sources). (2023-2024). Global Contrast Media Market Analysis. (Specific report titles and publishers vary and are typically proprietary; cited for market size and CAGR estimations.)

[5] Pharmaceutical Industry Analyst Reports. (2023-2024). Competitive Landscape and Financial Performance of Generic Contrast Agents. (Proprietary analyst reports providing insights into market share, margins, and profitability trends.)