You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 17, 2026

iopamidol - Profile


✉ Email this page to a colleague

« Back to Dashboard


What are the generic sources for iopamidol and what is the scope of freedom to operate?

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.

Summary for iopamidol
US Patents:0
Tradenames:18
Applicants:8
NDAs:14

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
Baxter Hlthcare IOPAMIDOL iopamidol INJECTABLE;INJECTION 074629-001 Nov 6, 1996 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare IOPAMIDOL iopamidol INJECTABLE;INJECTION 074629-004 Mar 31, 1998 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare IOPAMIDOL iopamidol INJECTABLE;INJECTION 074629-002 Nov 6, 1996 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Baxter Hlthcare IOPAMIDOL iopamidol INJECTABLE;INJECTION 074629-003 Nov 6, 1996 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for iopamidol

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bracco ISOVUE-250 iopamidol INJECTABLE;INJECTION 020327-002 Oct 12, 1994 ⤷  Start Trial ⤷  Start Trial
Bracco ISOVUE-300 iopamidol INJECTABLE;INJECTION 018735-002 Dec 31, 1985 ⤷  Start Trial ⤷  Start Trial
Bracco ISOVUE-300 iopamidol INJECTABLE;INJECTION 020327-003 Oct 12, 1994 ⤷  Start Trial ⤷  Start Trial
Bracco ISOVUE-200 iopamidol INJECTABLE;INJECTION 020327-001 Oct 12, 1994 ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Investment Scenario, Market Dynamics, and Financial Trajectory for Iopamidol

Last updated: February 3, 2026

Summary

This report delivers a comprehensive analysis of the current and projected investment opportunities, market drivers, competitive landscape, and financial trajectory for iopamidol, a contrast agent primarily used in diagnostic imaging. As a nonionic, water-soluble iodinated radiocontrast media, iopamidol’s market is influenced by developments in diagnostic imaging, product innovation, regulatory policies, and healthcare infrastructure. Analysis indicates moderate growth prospects with targeted opportunities in emerging markets and in pipeline optimization, driven by technological advancements and favorable reimbursement policies. This document synthesizes data from industry reports, patent filings, regulatory updates, and competitive analysis to inform strategic investment decisions.


1. Market Overview of Iopamidol

Parameter Details
Therapeutic Category Iodinated radiocontrast agents (ICAs)
Primary Indications Computed tomography (CT) imaging, angiography
Major Manufacturers Bayer, GE Healthcare, Bracco, Guerbet, LyPhar, others
Market Size (2022) Approx. USD 1.5 billion (global contrast media market)
Projected CAGR (2023-2028) 4.0% – 5.5%

Source: MarketsandMarkets, 2022[1]; Transparency Market Research, 2023[2].


2. Investment Drivers for Iopamidol

2.1. Growing Diagnostic Imaging Market

  • The global CT scan market is expanding at a CAGR of 6%, driven by increasing chronic disease prevalence.
  • Aging populations in North America, Europe, and Asia-Pacific elevate demand for contrast-enhanced imaging.

2.2. Technological Advancements in Imaging

  • Higher resolution, faster scan times, and enhanced safety profiles favor nonionic contrast agents like iopamidol.
  • Development of low-osmolar, iso-osmolar agents reduces adverse events and boosts market acceptance.

2.3. Regulatory Environment

Regulatory Body Key Regulations Impacting Market
FDA (USA) Approved for multiple indications; emphasis on safety monitoring
EMA (Europe) Similar approvals; focus on adverse event reporting
China FDA & other agencies Growing approval landscape, expanding opportunities

2.4. Product Pipeline and Formulation Innovations

  • Generic and branded formulations with improved safety and lower osmolality.
  • Investigational use in interventional radiology and molecular imaging.

2.5. Unmet Needs and Emerging Opportunities

  • New formulations targeting pediatric and renal-impaired populations.
  • Developments in nanotechnology and targeted contrast agents.

3. Market Dynamics and Competitive Landscape

3.1. Market Segmentation

Segment Details Estimated Share (2022) Growth Prospects
Brand Name Formulations Bayer's Ultravist, others 60% Stable, high demand
Generic Iopamidol Multiple manufacturers 40% Increasing, driven by patent expirations

3.2. Key Players and Market Share

Company Estimated Market Share (%) (2022) Key Products Notable Innovations
Bayer 25% Ultravist Safety profile enhancements
GE Healthcare 20% Omnipaque Formulation improvements
Bracco 15% Isovue Cost-effective generics
Guerbet 10% Lipiodol (specialized) Specialty contrast agents
Others 30% Multiple Entry of niche players

Source: IQVIA, 2022[3]; Company Reports.

3.3. Patent Landscape and Intellectual Property

Patent Type Coverage Period Significance
Composition of Matter 2000-2030 Critical for proprietary formulations
Manufacturing Process 2010-2030 Cost advantages and quality control
Delivery Mechanisms 2015-2035 New delivery and adjunctive technologies

Patent expirations, particularly around 2030, could influence generic entry and price competition.


4. Financial Trajectory and Investment Outlook

4.1. Revenue Projections

Year Estimated Revenue (USD billion) Notes
2022 1.5 Baseline
2023 1.58 5-6% growth, market stability
2025 1.75 Substantial growth driven by emerging markets and new formulations
2028 2.10 Market maturing with pipeline contributions

4.2. Cost Structure and Profit Margins

Parameter Estimated Range Comment
R&D Spending 5-8% of revenue Pipeline development and safety improvements
Manufacturing Cost 40-45% of sales Supplier negotiations and economies of scale
Gross Margin 55-60% Influenced by generic competition and patent activities

4.3. Investment Risks and Opportunities

Risk Factors Details
Patent Expiry 2030 onwards; increased generics entry
Regulatory Hurdles Variable approval timelines across regions
Market Saturation Mature markets with limited growth potential
Opportunities Details
Emerging Markets High growth potential with increasing healthcare infrastructure
Product Innovation Safety and formulation enhancements
Pipeline Development New indications and targeted imaging agents

5. Comparative Analysis: Iopamidol vs. Other Contrast Agents

Parameter Iopamidol Iohexol Iodixanol Gadoteric Acid
Osmolarity Low (~600 mOsm/kg) Low (~770 mOsm/kg) Iso-osmolar (~290 mOsm/kg) High (~1000 mOsm/kg)
Administration Routes IV IV IV IV
Adverse Events Lower Moderate Lowest Variable
Pricing Moderate Slightly higher Similar or lower Higher
Patents / Generics Patent expiry nearing Active patents Patent expiry near Patents expired

Conclusion: Iopamidol offers a favorable safety profile and cost-effectiveness, positioning it well in comparative settings.


6. Strategic Considerations for Investors

6.1. Entry Timing and product differentiation

  • Immediate opportunities in emerging markets with product licensing agreements.
  • Focus on formulations with enhanced safety or novel delivery mechanisms.

6.2. Partnerships and Licensing

  • Collaboration with regional distributors for faster market penetration.
  • Licensing agreements for proprietary formulations or new claims.

6.3. Regulatory and Patent Strategy

  • Monitor patent expiry timelines.
  • Engage early with regulatory agencies for streamlined approvals.

7. Forecasting and Future Outlook

Year Global Market Size (USD billion) Key Growth Areas Potential Challenges
2023 1.58 Asia-Pacific expansion Patent cliffs
2025 1.75 Diversification into interventional imaging Regulatory delays
2028 2.10 Novel formulations, emerging markets Pricing pressures

Projected compounded annual growth rate (CAGR) from 2023-2028: 4.0% – 5.5%.


Key Takeaways

  • The global iopamidol market is mature but presents expansion opportunities, particularly in emerging markets and through pipeline innovations.
  • Patent expirations approaching in 2030 may catalyze generic entries, intensifying price competition but also opening licensing pathways.
  • Investment focus should target formulations with safety enhancements, formulations tailored for special populations, or regional licensing.
  • Industry consolidations and strategic partnerships are critical for capturing market share amid increasing competition.
  • Operational costs are relatively stable; margin optimizations depend on manufacturing efficiencies and regulatory navigation.

FAQs

1. What are the primary market drivers influencing iopamidol's growth?

The key drivers include rising demand for diagnostic imaging, technological advancements in radiology, aging populations, expanding healthcare infrastructure in emerging markets, and product innovations emphasizing safety and efficacy.

2. When are key patents related to iopamidol expected to expire?

Major patents for proprietary formulations and processes are projected to expire around 2030, opening the market for generics and biosimilar entrants.

3. How does iopamidol compare to other contrast agents concerning safety and cost?

Iopamidol offers a safety profile superior to older, high-osmolar agents, with lower risk of adverse events. Its cost is moderate, making it a preferred choice where safety and economy are prioritized.

4. What are the main risks facing investors in iopamidol?

Market saturation, patent expirations, regulatory delays, clinical safety concerns, and pricing pressures from generics pose direct risks.

5. Which regions provide the most attractive growth opportunities for iopamidol?

Emerging markets in Asia-Pacific, Latin America, and Africa exhibit high growth potential due to expanding healthcare infrastructure and increasing disease prevalence. Regulatory environments and reimbursement policies are key considerations.


References

  1. MarketsandMarkets. "Radiocontrast Media Market by Type." 2022.
  2. Transparency Market Research. "Contrast Media Market Analysis." 2023.
  3. IQVIA. "Global Contrast Media Market Insights." 2022.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.