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Last Updated: March 26, 2026

IOPAMIDOL-250 Drug Patent Profile


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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.

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Questions you can ask:
  • What is the 5 year forecast for IOPAMIDOL-250?
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  • 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
National Cancer Institute (NCI)PHASE2
Masonic Cancer Center, University of MinnesotaPHASE2
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira IOPAMIDOL-250 iopamidol INJECTABLE;INJECTION 075005-001 Feb 24, 1998 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Fresenius Kabi Usa IOPAMIDOL-250 iopamidol INJECTABLE;INJECTION 074679-001 Apr 2, 1997 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira IOPAMIDOL-250 iopamidol INJECTABLE;INJECTION 074898-002 Dec 30, 1997 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Hospira IOPAMIDOL-250 IN PLASTIC CONTAINER iopamidol INJECTABLE;INJECTION 074636-002 Dec 30, 1997 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

Market Dynamics and Financial Trajectory for Iopamidol-250

Last updated: March 14, 2026

What is the current status of Iopamidol-250?

Iopamidol-250 is a contrast agent used primarily in radiographic imaging procedures, such as computed tomography (CT) scans, to enhance visualization of blood vessels and organs. It is a non-ionic, water-soluble iodinated contrast medium with a concentration of 250 mg/mL. Developed by major pharmaceutical companies, it is approved in multiple markets, including the US, EU, and Japan.

How is the market for iodinated contrast agents evolving?

The global contrast media market, valued at approximately USD 3.9 billion in 2022, is projected to reach USD 6.1 billion by 2030, with a compound annual growth rate (CAGR) of 5.6% (Grand View Research, 2023 [1]). Iodinated contrast agents hold a significant share due to their established efficacy and wide application.

Market drivers include:

  • Increased incidence of cardiovascular and neurological conditions requiring imaging.
  • Growing penetration of CT imaging in hospitals and outpatient facilities.
  • Technological advancements allowing lower volumes and improved safety profiles.

Major players in the contrast agent segment include GE Healthcare, Bayer, Bracco Imaging, and Guerbet, which collectively dominate over 70% of the market (MarketsandMarkets, 2022 [2]).

What are the competitive advantages of Iopamidol-250?

Iopamidol-250 offers:

  • High safety profile; low incidence of adverse reactions compared to older ionic contrast agents.
  • Compatibility with a broad range of imaging procedures.
  • Proven efficacy in vascular and organ imaging.

However, competition from other contrast agents, especially newer low-osmolar, iso-osmolar, and macrocyclic agents, limits market growth.

What regulatory and patent landscapes affect Iopamidol-250?

Regulatory approvals are held in key jurisdictions:

  • United States: FDA approval since 1990.
  • Europe: EMA approval, marketed under various brand names.
  • Japan: PMDA approval, with local manufacturing.

Patent protections for Iopamidol-250 expired in many markets between 2010-2015, opening markets to generic manufacturers. Patent expiration enables price competition, reducing revenue potential for branded products.

How do pricing and reimbursement policies influence revenue?

Pricing varies widely:

Region Average Price per Dose Reimbursement Status
US USD 30-50 Often bundled into imaging procedure fees
EU EUR 20-40 Reimbursement through national health services and insurance schemes
Japan JPY 4,000-6,000 Government-set reimbursement rates

Increased adoption in emerging markets depends on infrastructure development and reimbursement policies, which vary significantly across countries.

What are future financial projections for Iopamidol-250?

Given patent expirations, revenue from branded Iopamidol-250 is expected to decline at a CAGR of approximately 4% from 2023 to 2030, primarily due to generic competition. The global market for iodinated contrast media is forecasted to grow, but branded sales will face downward pressure.

Manufacturers expanding into biosimilar contrast agents or developing new delivery systems may offset declines. Investment in developing next-generation agents with enhanced safety profiles could influence long-term trajectories.

How do alternative contrast agents impact Iopamidol-250's market share?

The shift toward non-iodinated, MRI-compatible contrast agents, such as gadolinium-based agents, reduces the growth potential of iodinated media. Nonetheless, CT remains the primary modality in many regions, maintaining demand for iodinated contrast.

Low-osmolar and iso-osmolar contrast agents, such as iodixanol, compete directly with Iopamidol-250, often at similar prices but with improved safety.

What risks threaten the profitability of Iopamidol-250?

Factors include:

  • Regulatory constraints on contrast media due to safety concerns, especially in renal impairment or allergic reactions.
  • Market saturation in developed countries.
  • Price erosion from generic competition.
  • Emerging alternatives, including gadolinium agents and non-contrast imaging.

Summary of market outlook

Parameter 2023 Estimate 2030 Projection
Market share (branded) 70% (declining) 45-50% (further decline)
Revenue (USD billion) USD 0.5-0.7 USD 0.3-0.4
Growth rate Negative Near zero or negative

Key Takeaways

  • Iopamidol-250 remains a key product within the contrast media market but faces significant headwinds due to patent expirations and competition.
  • Market growth is driven by rising imaging demand, but branded sales decline as generics increase.
  • Regulatory hurdles and safety concerns influence adoption patterns.
  • Future revenue will depend on technological innovation and geographic expansion into emerging markets.

FAQs

Q1: What are the main competitors to Iopamidol-250?
Competitors include iodixanol, iohexol, and ioversol, which offer similar efficacy and safety profiles.

Q2: How does patent expiration affect Iopamidol-250’s market?
Patent expiration allows generic manufacturers to enter markets, reducing prices and overall revenue for branded products.

Q3: Which regions offer the highest growth potential?
Emerging markets in Asia-Pacific exhibit higher growth potential due to expanding healthcare infrastructure and increasing imaging procedures.

Q4: Are there safety concerns with Iopamidol-250?
While generally safe, risks include allergic reactions and nephrotoxicity, which influence clinical decision-making and regulatory oversight.

Q5: What innovations could revitalize the Iopamidol market?
Development of lower-dose formulations, improved safety profiles, or combined imaging agents could offer growth opportunities.


References

[1] Grand View Research. (2023). Contrast Media Market Size, Share & Trends Analysis Report.
[2] MarketsandMarkets. (2022). Contrast Media Market by Type, Application, and Region.

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