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Last Updated: March 27, 2026

IOPAMIDOL-250 IN PLASTIC CONTAINER Drug Patent Profile


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When do Iopamidol-250 In Plastic Container patents expire, and what generic alternatives are available?

Iopamidol-250 In Plastic Container is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in IOPAMIDOL-250 IN PLASTIC CONTAINER 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 In Plastic Container

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

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  • What is the 5 year forecast for IOPAMIDOL-250 IN PLASTIC CONTAINER?
  • What are the global sales for IOPAMIDOL-250 IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for IOPAMIDOL-250 IN PLASTIC CONTAINER?
Summary for IOPAMIDOL-250 IN PLASTIC CONTAINER
Drug patent expirations by year for IOPAMIDOL-250 IN PLASTIC CONTAINER
Recent Clinical Trials for IOPAMIDOL-250 IN PLASTIC CONTAINER

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SponsorPhase
Masonic Cancer Center, University of MinnesotaPHASE2
National Cancer Institute (NCI)PHASE2
Army Medical Center of PLAN/A

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US Patents and Regulatory Information for IOPAMIDOL-250 IN PLASTIC CONTAINER

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
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 in Plastic Container

Last updated: March 2, 2026

Overview of the Drug

Iopamidol-250 is an iodine-based contrast agent used in X-ray imaging procedures like computed tomography (CT). The formulation in a plastic container enhances portability and ease of use. Iopamidol-250 is marketed primarily for diagnostic imaging, with a focus on vascular and tissue imaging.

Market Size and Growth Projections

Global Contrast Agent Market

The contrast agent market, encompassing both iodine-based and gadolinium-based products, reached approximately USD 3.9 billion in 2022. The market is expected to grow at a CAGR of around 4.5% through 2030, driven by increasing imaging procedures and technological advances.

Iodine-based Contrast Agents Segment

Iodine-based contrast agents dominate the market, with a valuation of USD 2.1 billion in 2022. Key products include iohexol, iodixanol, and iopamidol. Iopamidol holds a significant share within this segment, estimated at 25%, with revenues of around USD 525 million in 2022.

Regional Market Breakdown

Region Market Share (2022) Growth Rate (2023-2030) Notes
North America 40% 4.0% Mature market, high imaging volume
Europe 25% 4.5% Strong healthcare infrastructure
Asia-Pacific 20% 6.0% Rapidly expanding imaging services
Latin America 8% 4.0% Growing healthcare access
Middle East & Africa 7% 4.5% Increasing adoption of CT scans

Drivers of Market Growth

  • Aging populations increasing demand for diagnostic imaging.
  • Advancements in imaging technology requiring contrast agents.
  • Rising healthcare expenditure in emerging markets.
  • Elevated concerns over contrast agent safety and improved formulations.

Competitive Landscape

Major manufacturers include GE Healthcare, Bracco Imaging, and Bayer HealthCare. Iopamidol-250 marketed in plastic containers is primarily supplied by regional and specialty pharmaceutical firms.

Company Market Share (Est.) Key Products Focus Areas
GE Healthcare 40% Omnipaque, Visipaque Broad imaging solutions
Bracco Imaging 35% Iohexol, Iopamiro Specialized contrast agents
Bayer Healthcare 15% Ultravist, Isovue Global presence, innovation
Others 10% Various regional brands Niche and specialty products

Pricing and Revenue Outlook

Pricing Structure

  • Average wholesale price per vial (250 mgI/mL) in a plastic container: USD 15–25.
  • Dose volume: generally 50–150 mL per injection.
  • Estimated cost per full dose: USD 750–3,750 depending on volume and market.

Revenue Forecast

Assuming a conservative market penetration with 10% of the iodine contrast segment and an annual utilization of 10 million doses globally:

Year Estimated Doses (millions) Revenue (USD millions) Notes
2023 1 150–250 Initial adoption stage
2025 3 450–750 Increased clinical use
2027 5 750–1,250 Market expansion
2030 8 1,200–2,000 Market maturity

Regulatory and Adoption Factors

  • Regulatory approvals influence market access; approvals in major markets like FDA (U.S.) and EMA (Europe) are required.
  • Preference for plastic containers hinges on safety, convenience, and cost.
  • Patient safety concerns, notably allergic reactions and renal impairment, influence product formulation and adoption.

Challenges and Opportunities

Challenges

  • Competition from ultrasound and MRI modalities reducing contrast need.
  • Stringent regulations on iodine contrast safety.
  • Limited differentiation among products; price sensitivity dominates purchasing decisions.

Opportunities

  • Development of lower-osmolarity formulations to reduce adverse events.
  • Incremental market growth via expanding imaging procedures in emerging economies.
  • Partnership opportunities with hospital networks and imaging centers.

Financial Risks

  • Regulatory delays can postpone product launches and revenue.
  • Price competition limits margins.
  • Patent expirations for comparator products may pressure pricing strategies.

Key Takeaways

  • The global contrast agent market, especially iodine-based agents like Iopamidol-250, exhibits steady growth driven by increased diagnostic imaging, aging populations, and technological advances.
  • Market share is dominated by large players, with regional firms filling niche segments.
  • Pricing remains sensitive, with unit cost strongly influenced by formulation, container type, and regional health policies.
  • Revenue projections indicate moderate growth potential, with a focus on expanding clinical use and emerging markets.
  • Challenges include regulatory hurdles and competitive pressures; opportunities exist in formulation improvements and global outreach.

5 FAQs

1. What is the primary driver for Iopamidol-250's market growth?
The increase in diagnostic imaging procedures globally, supported by aging populations and technological advancements, drives market growth.

2. How does plastic container packaging influence market acceptance?
Plastic containers improve safety, portability, and ease of administration, promoting adoption in clinical settings.

3. What regulatory considerations impact market entry?
Approvals from agencies like the FDA and EMA are necessary; safety profile and manufacturing standards influence approval timing and market access.

4. Who are the key competitors in this segment?
Major players include GE Healthcare, Bracco Imaging, and Bayer HealthCare, occupying substantial shares of the iodine contrast agent market.

5. What are the main cost factors for Iopamidol-250 in clinical use?
Pricing depends on formulation, container type, regional pricing policies, and competition. The average wholesale cost per vial ranges from USD 15 to 25.


References

[1] MarketsandMarkets. (2023). Contrast Agents Market by Type, Application, and Region. Retrieved from https://www.marketsandmarkets.com
[2] Grand View Research. (2022). Contrast Media Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com
[3] U.S. Food and Drug Administration. (2022). Safety of Iodinated Contrast Agents. https://www.fda.gov
[4] European Medicines Agency. (2022). Clinical Evaluation of Contrast Agents. https://www.ema.europa.eu

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