IOPAMIDOL-300 Drug Patent Profile

Which patents cover Iopamidol-300, and what generic alternatives are available?

Iopamidol-300 is a drug marketed by Abbvie, Cook Imaging, Fresenius Kabi Usa, and Hospira. and is included in seven NDAs.

The generic ingredient in IOPAMIDOL-300 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-300

A generic version of IOPAMIDOL-300 was approved as iopamidol by HAINAN POLY on February 27^th, 2023.

Summary for IOPAMIDOL-300

US Patents:	0
Applicants:	4
NDAs:	7

US Patents and Regulatory Information for IOPAMIDOL-300

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074638-001	Apr 30, 1997		DISCN	No	No
Hospira	IOPAMIDOL-300 IN PLASTIC CONTAINER	iopamidol	INJECTABLE;INJECTION	074637-001	Apr 3, 1997		DISCN	No	No
Hospira	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074898-003	Dec 30, 1997		DISCN	No	No
Cook Imaging	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074881-003	Jul 28, 2000		DISCN	No	No
Fresenius Kabi Usa	IOPAMIDOL-300	iopamidol	INJECTABLE;INJECTION	074679-002	Apr 2, 1997		DISCN	No	No
Hospira	IOPAMIDOL-300 IN PLASTIC CONTAINER	iopamidol	INJECTABLE;INJECTION	074636-003	Dec 30, 1997		DISCN	No	No

IOPAMIDOL-300: Market Fundamentals and Investment Outlook

Last updated: February 19, 2026

Iopamidol-300, a non-ionic, low-osmolar contrast agent, holds a significant position in diagnostic imaging. Its established efficacy and safety profile support a stable market, albeit one subject to evolving market dynamics and competitive pressures. This analysis examines the fundamental drivers, patent landscape, and future investment considerations for Iopamidol-300.

What is the Market Landscape for Iopamidol-300?

The global market for iodinated contrast media, including Iopamidol-300, is driven by the increasing demand for diagnostic imaging procedures. These procedures, such as computed tomography (CT) and angiography, are crucial for the detection, diagnosis, and monitoring of various medical conditions.

Key Market Drivers

• Aging Global Population: The demographic shift towards an older population is a primary driver, as age-related diseases often require extensive diagnostic imaging. The World Health Organization projects that the proportion of people aged 60 years and over will increase from 12% in 2015 to 22% in 2050 [1]. This demographic trend directly correlates with higher utilization of diagnostic imaging services.
• Prevalence of Chronic Diseases: The rising incidence of cardiovascular diseases, cancer, and neurological disorders necessitates frequent imaging for diagnosis and management. For instance, cancer is the leading cause of death globally, with over 19 million new cases diagnosed in 2020 [2]. CT scans are a cornerstone of cancer diagnosis and staging.
• Technological Advancements in Imaging: Improvements in CT and magnetic resonance imaging (MRI) technology, including higher resolution and faster scan times, have led to increased demand for contrast agents to enhance image quality. The introduction of dual-energy CT scanners, for example, allows for more detailed tissue characterization, often employing contrast agents.
• Growing Healthcare Expenditure: Increased investment in healthcare infrastructure and accessibility, particularly in emerging economies, expands the reach of diagnostic imaging services. Global healthcare spending is projected to reach $10.059 trillion by 2022 [3].

Market Segmentation

The Iopamidol-300 market can be segmented by:

• Application:
  • Computed Tomography (CT) Angiography
  • Conventional Angiography
  • Urography
  • Other applications (e.g., venography, myelography)
• End-User:
  • Hospitals
  • Diagnostic Imaging Centers
  • Academic and Research Institutions
• Distribution Channel:
  • Hospital Pharmacies
  • Retail Pharmacies
  • Direct Sales

Competitive Landscape

The market for iodinated contrast media is competitive, with several established players and generic manufacturers. Key competitors offering Iopamidol-300 or similar agents include:

• Bracco Imaging S.p.A. (Omnipaque, Iohexol)
• GE Healthcare (Ultravist, Iopromide)
• Bayer AG (Gadovist, Magnevist - though these are gadolinium-based contrast agents, they compete for diagnostic imaging market share)
• Tapo Pharmaceutical Industry Co., Ltd. (Iopamidol)
• LPI (Shanghai) Pharmaceutical Co., Ltd. (Iopamidol)

The market is characterized by a mix of branded and generic products. Once patents expire, generic competition can lead to price erosion.

What is the Patent Landscape for Iopamidol-300?

Iopamidol itself is a well-established molecule with its foundational patents long expired. However, patent protection can extend to various aspects of the drug, including manufacturing processes, specific formulations, and novel delivery methods.

Core Compound Patent Status

The original patents covering the chemical entity iopamidol have expired. This means that the active pharmaceutical ingredient (API) itself is no longer under compound patent protection in major markets. The molecule was first developed by Bracco.

Potential Areas of Ongoing Patent Protection

While the core compound is off-patent, manufacturers may hold patents related to:

• Manufacturing Processes: Novel or improved synthetic routes for producing iopamidol with higher purity, reduced impurities, or greater efficiency can be patented. This is particularly relevant for generic manufacturers seeking to establish their own production capabilities.
• Formulations: Patents may cover specific excipient combinations, stabilizers, or pH adjustments that improve the stability, solubility, or injectability of iopamidol solutions. This can include cryoprotective agents or buffering systems.
• Delivery Systems: Innovations in how iopamidol is delivered, such as pre-filled syringes with specialized tips, novel vial designs, or even combinations with other imaging agents, could be patentable.
• Polymorphs and Salts: Discovery and patenting of specific crystalline forms (polymorphs) or salt forms of iopamidol with advantageous properties (e.g., enhanced stability, easier handling) can provide additional layers of protection.
• Combination Therapies: While less common for contrast agents, if iopamidol were to be combined with another therapeutic agent for a specific diagnostic or therapeutic purpose, that combination could be patented.

Impact of Patent Expirations

The expiration of original iopamidol patents has paved the way for generic manufacturers to enter the market. This has led to:

• Increased Competition: A rise in the number of suppliers offering iopamidol products.
• Price Reductions: Generic competition typically drives down prices, increasing affordability and accessibility.
• Market Share Shifts: Branded manufacturers may see a gradual erosion of market share to lower-cost generic alternatives.

Companies that previously held strong market positions based on the original iopamidol patents must now compete on manufacturing efficiency, supply chain reliability, and product quality.

What are the Regulatory Considerations for Iopamidol-300?

Iopamidol-300 is a pharmaceutical product requiring stringent regulatory approval and ongoing compliance in all markets where it is sold.

Key Regulatory Aspects

• Approval Pathways: Manufacturers must obtain marketing authorization from regulatory agencies such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and national regulatory bodies in other countries. This typically involves submitting extensive dossiers detailing the drug's chemistry, manufacturing, and controls (CMC), non-clinical studies, and clinical trial data demonstrating safety and efficacy.
• Generic Drug Approvals: For generic versions of iopamidol, regulatory submissions (e.g., Abbreviated New Drug Applications in the US) must demonstrate bioequivalence to the reference listed drug. This requires proving that the generic product has the same active ingredient, dosage form, strength, and route of administration, and that it performs in the same way as the reference product in the body.
• Good Manufacturing Practices (GMP): Manufacturing facilities must adhere to strict GMP regulations to ensure consistent product quality and safety. Regular inspections by regulatory authorities are standard.
• Pharmacovigilance: Post-market surveillance is critical. Manufacturers are responsible for monitoring and reporting adverse events associated with their products. This includes establishing robust systems for collecting, analyzing, and reporting safety data to regulatory agencies.
• Labeling and Prescribing Information: Product labeling must be accurate, comprehensive, and comply with regulatory requirements. This includes detailing indications, contraindications, warnings, precautions, adverse reactions, and dosage and administration.
• Quality Control: Robust quality control measures throughout the manufacturing process, from raw material testing to finished product release, are mandatory.

Recent Regulatory Trends

• Increased Scrutiny on Supply Chains: Regulatory agencies are placing greater emphasis on the security and reliability of pharmaceutical supply chains. This includes monitoring for potential drug shortages and ensuring that manufacturing sites are adequately controlled.
• Focus on Impurity Profiling: There is heightened regulatory attention on identifying and controlling process-related impurities and degradation products. Manufacturers must have sophisticated analytical methods to detect and quantify these substances.
• Digital Health and Data Integration: While not directly impacting iopamidol's core formulation, regulatory bodies are increasingly considering how digital health technologies interact with pharmaceutical products, which could influence future device-based delivery systems.

What are the Investment Considerations for Iopamidol-300?

Investing in Iopamidol-300 requires a thorough assessment of its market position, competitive pressures, and the long-term viability of its manufacturing and distribution.

Investment Rationale

• Established Market Demand: Iopamidol-300 is a mature product with consistent demand driven by the ongoing need for diagnostic imaging. This provides a degree of market stability.
• Cost-Effectiveness of Generics: The availability of generic iopamidol makes it an attractive option for healthcare providers seeking to manage costs, especially in price-sensitive markets.
• Essential Diagnostic Tool: As a widely used contrast agent, iopamidol-300 remains a critical component in many standard diagnostic protocols.

Risks and Challenges

• Generic Competition and Price Erosion: The primary risk is intense competition from generic manufacturers, which can lead to significant price declines and reduced profit margins.
• Technological Obsolescence: While iopamidol is effective, newer contrast agents or alternative imaging modalities could emerge that offer superior performance or safety profiles, potentially diminishing iopamidol's market share over time.
• Supply Chain Disruptions: Like all pharmaceutical products, iopamidol manufacturing and distribution can be vulnerable to supply chain disruptions, including raw material shortages, manufacturing issues, or logistics challenges.
• Regulatory Changes: Evolving regulatory requirements or increased scrutiny on manufacturing processes could lead to additional compliance costs or market access challenges.
• Limited Innovation Potential: As a mature, off-patent molecule, the potential for significant product innovation or differentiation is limited, unless through novel delivery systems or formulation enhancements.

Investment Strategies

• Focus on Manufacturing Efficiency: For manufacturers, investing in optimized production processes, economies of scale, and robust quality control is crucial to maintaining competitiveness in a generic market.
• Supply Chain Dominance: Companies that can ensure reliable supply and efficient distribution, particularly to large hospital networks or government tenders, can secure stable revenue streams.
• Geographic Market Expansion: Identifying and penetrating emerging markets with growing healthcare infrastructure can provide opportunities for growth.
• Niche Formulation or Delivery Innovation: While challenging, developing and patenting improved formulations or novel delivery devices for iopamidol could create a competitive advantage and justify premium pricing.
• Acquisition of Manufacturing Capabilities: For investment funds, acquiring established generic manufacturers with strong operational control and established market access for iopamidol can be a viable strategy.

Key Takeaways

• Iopamidol-300 is a widely used, non-ionic, low-osmolar contrast agent with sustained demand driven by demographic trends and the prevalence of chronic diseases requiring diagnostic imaging.
• The core compound patent for iopamidol has expired, leading to a competitive generic market. Ongoing patent protection is typically limited to manufacturing processes, specific formulations, or delivery methods.
• Regulatory compliance, including GMP adherence and robust pharmacovigilance, is critical for market access and maintaining product integrity.
• Investment in Iopamidol-300 presents a stable but highly competitive landscape. Success hinges on manufacturing efficiency, supply chain reliability, and cost management rather than novel drug development.
• Risks include intense generic price erosion, potential technological obsolescence, and supply chain vulnerabilities.

Frequently Asked Questions

1. What is the primary advantage of Iopamidol-300 over older, ionic contrast agents? Iopamidol-300 is a non-ionic, low-osmolar contrast agent, which generally leads to a lower incidence of adverse reactions, such as pain, heat sensation, and vasodilation, compared to older, high-osmolar ionic contrast media. Its osmolality is closer to that of blood, reducing physiological disruption.

2. How significant is the impact of generic competition on Iopamidol-300 pricing? The impact of generic competition is substantial. Following patent expiry, multiple manufacturers enter the market, leading to increased supply and driving down prices significantly. This can reduce profit margins for both branded and generic players, necessitating a focus on high-volume production and operational efficiency.

3. Are there any emerging applications or novel uses for Iopamidol-300 being explored? While Iopamidol-300 is a mature product primarily used in established diagnostic imaging procedures (CT, angiography, urography), research into novel delivery systems or formulations that improve patient comfort or streamline administration might occur. However, significant expansion into entirely new therapeutic or diagnostic areas for the molecule itself is unlikely due to its established role.

4. What are the typical adverse effects associated with Iopamidol-300? While generally well-tolerated, adverse effects can occur. Common reactions include mild warmth, nausea, vomiting, and transient changes in blood pressure or heart rate. More severe, but rarer, reactions can include allergic-type responses, anaphylaxis, or contrast-induced nephropathy, particularly in patients with pre-existing renal impairment.

5. How does Iopamidol-300 compare to other common non-ionic, low-osmolar contrast agents like Iohexol or Iopromide? Iopamidol-300, Iohexol, and Iopromide are all classified as non-ionic, low-osmolar contrast media and share similar safety and efficacy profiles. Minor differences may exist in their exact osmolality, viscosity, or excipient compositions, which can lead to subtle variations in patient tolerability or specific procedural suitability. Clinicians select agents based on patient factors, procedural requirements, and formulary availability.

Citations

[1] United Nations Department of Economic and Social Affairs, Population Division (2019). World Population Prospects 2019: Highlights. [2] Sung, H., Ferlay, J., Siegel, R. L., Laversanne, M., Soerjomataram, I., Jemal, A., & Bray, F. (2021). Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA: A Cancer Journal for Clinicians, 71(3), 209–249. [3] Deloitte (2020). Global Health Care Outlook 2020.