You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 11, 2025

IOPAMIDOL-250 Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Iopamidol-250 patents expire, and when can generic versions of Iopamidol-250 launch?

Iopamidol-250 is a drug marketed by Cook Imaging, Fresenius Kabi Usa, and Hospira. and is included in five NDAs.

The generic ingredient in IOPAMIDOL-250 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-250

A generic version of IOPAMIDOL-250 was approved as iopamidol by HAINAN POLY on February 27th, 2023.

  Get Started Free

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for IOPAMIDOL-250?
  • What are the global sales for IOPAMIDOL-250?
  • What is Average Wholesale Price for IOPAMIDOL-250?
Summary for IOPAMIDOL-250
US Patents:0
Applicants:3
NDAs:5
Raw Ingredient (Bulk) Api Vendors: 79
Clinical Trials: 26
DailyMed Link:IOPAMIDOL-250 at DailyMed
Drug patent expirations by year for IOPAMIDOL-250
Recent Clinical Trials for IOPAMIDOL-250

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Masonic Cancer Center, University of MinnesotaPHASE2
National Cancer Institute (NCI)PHASE2
Chongqing Emergency Medical CenterN/A

See all IOPAMIDOL-250 clinical trials

US Patents and Regulatory Information for IOPAMIDOL-250

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-250 iopamidol INJECTABLE;INJECTION 074881-002 Jul 28, 2000 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira IOPAMIDOL-250 iopamidol INJECTABLE;INJECTION 075005-001 Feb 24, 1998 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa IOPAMIDOL-250 iopamidol INJECTABLE;INJECTION 074679-001 Apr 2, 1997 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira IOPAMIDOL-250 iopamidol INJECTABLE;INJECTION 074898-002 Dec 30, 1997 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Hospira IOPAMIDOL-250 IN PLASTIC CONTAINER iopamidol INJECTABLE;INJECTION 074636-002 Dec 30, 1997 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: IOPAMIDOL-250

Last updated: July 30, 2025


Introduction

The pharmaceutical landscape continues to evolve rapidly, driven by technological innovation, regulatory shifts, and the increasing demand for specialized imaging agents. Iopamidol-250, a radiographic contrast agent used primarily in computed tomography (CT) imaging, exemplifies this trend. As a non-ionic, low-osmolar contrast medium, Iopamidol-250 has carved a strategic niche within medical diagnostics. Understanding its market dynamics and financial trajectory provides vital insights for stakeholders, including biopharmaceutical companies, healthcare providers, and investors.


Market Overview

Global CT Contrast Media Market

The global CT contrast media market is projected to reach approximately USD 3.2 billion by 2027, growing at a CAGR of 4.8% from 2022 (1). Key drivers include the rising prevalence of cardiovascular and oncological diseases, aging populations, and technological advancements in imaging quality. Iopamidol-250, a derivative of the iohexol group, captures a significant share due to its favorable safety profile and efficacy.

Competitive Landscape

Major players in the contrast media segment include Bayer Healthcare, GE Healthcare, and Guerbet. Bayer's Omnipaque (iohexol-based contrast agent) dominates the market; however, Iopamidol-250 competes effectively through its optimized balance of iodine concentration and lower osmolarity, favoring patient safety.

Regulatory and Clinical Adoption Factors

Regulatory approvals from agencies such as the FDA and EMA influence market penetration. Iopamidol-250’s existing approvals, combined with demonstrated safety and diagnostic efficacy, facilitate broader adoption in developed markets like North America and Europe. Emerging markets increasingly adopt such agents as healthcare infrastructure improves.


Market Drivers

Advancements in Imaging Technology

Enhanced resolution and lower radiation doses in modern CT devices increase demand for superior contrast agents, favoring Iopamidol-250’s low-osmolarity formulation. The agent’s compatibility with latest imaging protocols accelerates its clinical acceptance.

Rising Incidence of Diseases

An escalation in cardiovascular and oncological cases necessitates high-quality diagnostic imaging. The increasing utilization of contrast-enhanced CT scans directly correlates with higher demand for contrast media.

Healthcare Infrastructure Development

Emerging markets, especially in Asia-Pacific, witness healthcare infrastructure upgrades, leading to increased adoption of advanced diagnostic tools, including contrast agents like Iopamidol-250.


Market Challenges

Safety and Regulatory Concerns

Adverse reactions, such as allergic responses and nephrotoxicity, pose challenges despite Iopamidol-250’s favorable profile. Regulatory vigilance and adverse event reporting impact market expansion.

Pricing and Reimbursement Dynamics

Pricing pressures and reimbursement policies influence profitability. In many markets, cost-containment measures limit pricing flexibility for contrast media.

Competition and Technological Alternatives

Emergence of new, safer contrast agents or alternative imaging modalities (e.g., MRI, ultrasound) could restrain demand growth.


Financial Trajectory and Revenue Projections

Historical Performance

Although publicly available data specific to Iopamidol-250 are limited due to its proprietary nature, the contrast media segment has exhibited steady growth. Bayer’s Omnipaque generated approximately USD 900 million in revenue in 2021, indicating the significant market size (2).

Forecasted Revenue Growth

Assuming Iopamidol-250 commands a 5-8% market share within the segment, driven by clinical preferences, hospital procurement strategies, and regional penetration, projected revenues could reach USD 150-200 million globally by 2027. This projection considers a compound annual growth rate aligned with market expansion and increased imaging procedures.

Impact of Patent Life and Competition

The expiration of patents and the entry of generic competitors will influence profit margins. Companies investing in formulation improvements and expanded indications could sustain growth over the next decade.

Pricing Trends

Global pricing strategies will evolve based on regional reimbursement schemes. In high-income countries, value-based pricing linked to diagnostic accuracy and safety profiles will dominate, potentially supporting higher margins.


Strategic Considerations for Stakeholders

Investment and R&D Focus

Investing in refining formulations that enhance safety and reduce side effects could expand the patient base. Additionally, pursuing new indications—such as pediatric or renal-compromised patient use—may open additional revenue streams.

Market Expansion Strategies

Targeting emerging markets with tailored pricing and education campaigns to build clinician confidence can accelerate market share. Partnering with local distributors and healthcare providers is pivotal.

Regulatory and Compliance Navigation

Proactive engagement with regulatory agencies ensures timely approvals for new indications or formulations, safeguarding the competitive positioning of Iopamidol-250.


Conclusion

The market dynamics surrounding Iopamidol-250 are shaped by technological innovation, increasing diagnostic demands, and regional healthcare development. While competitive pressures and safety considerations pose challenges, the overall financial trajectory remains promising, contingent upon strategic investments, regulatory navigation, and market expansion initiatives. Accurate forecasting underscores a growth trajectory aligned with the broader radiologic contrast media market, with substantial revenue potential for stakeholders aligned with industry trends.


Key Takeaways

  • Market growth aligns with advancements in CT imaging technology and rising global diagnostic procedures.
  • Iopamidol-250's favorable safety profile and low-osmolarity provide a competitive edge.
  • Emerging markets present significant expansion opportunities amid healthcare infrastructure development.
  • Patent expiries and generic competition necessitate innovation in formulation and indications.
  • Strategic investments in safety, efficacy, and regional partnerships are crucial for maximizing financial returns.

FAQs

1. What factors influence the demand for Iopamidol-250 globally?
Demand hinges on technological advancements in CT imaging, rising disease prevalence, and regional healthcare infrastructure. Clinical safety and efficacy also significantly impact adoption.

2. How does Iopamidol-250 compare to other contrast agents in safety and efficacy?
Iopamidol-250 offers low-osmolarity, reducing risks of adverse reactions compared to older ionic agents, thus favoring patient safety without compromising diagnostic quality.

3. What regions are primary targets for expanding Iopamidol-250 sales?
North America, Europe, and Asia-Pacific represent primary markets, with emerging economies in Asia and Latin America offering substantial expansion potential.

4. How are patent expirations impacting the Iopamidol-grade contrast media market?
Patent expirations lead to increased generic competition, exerting pricing pressure and prompting innovation to maintain profitability.

5. What strategies can companies adopt to sustain growth for Iopamidol-250?
Investing in formulation improvements, expanding approved indications, engaging in regional regulatory processes, and building local healthcare partnerships are key growth strategies.


References

  1. Grand View Research. Contrast Media Market Size, Share & Trends Analysis Report. 2022.
  2. Bayer Healthcare. Annual Report 2021.
  3. MarketsandMarkets. Contrast Media Market by Type, Application & Region—Forecast to 2027.

More… ↓

⤷  Get Started Free

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.