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Last Updated: March 27, 2026

IOPAMIDOL-200 IN PLASTIC CONTAINER Drug Patent Profile


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When do Iopamidol-200 In Plastic Container patents expire, and when can generic versions of Iopamidol-200 In Plastic Container launch?

Iopamidol-200 In Plastic Container is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in IOPAMIDOL-200 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-200 In Plastic Container

A generic version of IOPAMIDOL-200 IN PLASTIC CONTAINER 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-200 IN PLASTIC CONTAINER?
  • What are the global sales for IOPAMIDOL-200 IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for IOPAMIDOL-200 IN PLASTIC CONTAINER?
Summary for IOPAMIDOL-200 IN PLASTIC CONTAINER
Drug patent expirations by year for IOPAMIDOL-200 IN PLASTIC CONTAINER
Recent Clinical Trials for IOPAMIDOL-200 IN PLASTIC CONTAINER

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

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

See all IOPAMIDOL-200 IN PLASTIC CONTAINER clinical trials

US Patents and Regulatory Information for IOPAMIDOL-200 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-200 IN PLASTIC CONTAINER iopamidol INJECTABLE;INJECTION 074636-001 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-200 in Plastic Containers

Last updated: March 10, 2026

What is the current market landscape for Iopamidol-200?

Iopamidol-200 is an iodinated contrast agent used primarily for diagnostic imaging procedures such as computed tomography (CT). The global contrast media market, valued at approximately $4.9 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of 4.8% until 2030, buoyed by increased imaging procedures and expanding healthcare infrastructure in emerging markets [1]. Iopamidol-200 accounts for a significant share within this segment, owing to its widespread approval and established safety profile.

How does product format influence market adoption?

The packaging format—specifically plastic containers—affects distribution, storage, and administration. Plastic containers offer advantages in cost, weight, and ease of handling compared to glass vials. The trend towards single-dose, pre-filled plastic syringes has accelerated due to safety concerns and convenience, resulting in a shift toward plastic-based formats. Major manufacturers have transitioned their Iopamidol products to high-density polyethylene (HDPE) bottles and pre-filled syringes, aligning with regulatory initiatives to reduce contamination risks [2].

What are the key regional markets and their characteristics?

Region Market Size (2022) Growth Drivers Regulatory Trends
North America $2 billion High healthcare expenditure, established imaging practices Stringent safety standards favor high-quality formulations
Europe $1.2 billion Aging population, increased diagnostic procedures Accelerated approval pathways for contrast agents
Asia-Pacific $1 billion Rising healthcare infrastructure, large patient base Rapid approval of contrast media, local manufacturing incentives
Latin America $350 million Growing medical tourism, expanding imaging centers Variability in regulatory enforcement

North America and Europe hold the largest markets owing to their mature healthcare systems. Asia-Pacific demonstrates high growth potential, driven by infrastructure development and cost-effective manufacturing options.

What is the projected financial path for Iopamidol-200 in plastic containers?

Forecasting the trajectory involves estimating manufacturing and sales volumes, price points, and market share. Initial assumptions:

  • Market Penetration Rate: 15% in the contrast media segment in 2022
  • Price per Unit: $25 per vial (average for low-to-mid dose vials)
  • Annual Growth Rate: 5% in sales volume, aligned with imaging procedure increases

Revenue Projections (2023-2027)

Year Estimated Units Sold Revenue ($ millions) Remarks
2023 20 million $500 Gradual adoption, existing regulatory approvals
2024 21 million $525 Market expansion continues
2025 22 million $550 Introduction into emerging markets
2026 23 million $575 Increased use in developing diagnostic protocols
2027 24 million $600 Maturation of market segments

This simplified analysis indicates modest growth, constrained by competitive pressure from other contrast agents and regulatory costs. Margins depend on manufacturing efficiency, which is steadily improving through automation and process optimization.

What are the regulatory and competitive challenges?

Regulatory agencies such as the FDA and EMA demand rigorous testing of contrast agents for safety, efficacy, and supply chain integrity. Pre-filled plastic containers must meet stringent standards for sterility and stability. The ongoing development of alternatives, including gadolinium-based and newer iodine agents, poses competitive risks. Patent expiration for older formulations and growth in biosimilars could pressure pricing and market share.

What is the significance of supply chain considerations?

Plastic container manufacturing relies on high-quality polymers with proven biocompatibility. Supply chain disruptions, especially during global crises like COVID-19, have affected production volumes. Companies are diversifying manufacturing locations and establishing local production capabilities to mitigate risks.

How do pricing and reimbursement policies impact profitability?

Reimbursement frameworks, heavily regulated in Medicare and private insurance schemes in the U.S., influence market penetration. Price controls or shifting reimbursement rates toward value-based models could pressure profit margins. Volume-based discounting is common as competition intensifies.

What are the key takeaways?

  • The global contrast media market is projected to grow at approximately 4.8% CAGR through 2030.
  • Plastic containers, especially pre-filled syringes, dominate the packaging landscape due to safety and convenience.
  • Regional growth varies, with North America and Europe leading, yet Asia-Pacific offers high expansion potential.
  • Revenue for Iopamidol-200 in plastic containers is forecasted to reach around $600 million by 2027, assuming steady adoption.
  • Regulatory standards, supply chain resilience, and competitive innovations remain influencing factors.

FAQs

  1. What factors influence the pricing of Iopamidol-200?
    Pricing is affected by manufacturing costs, competitive landscape, procurement negotiations with healthcare providers, and regulatory compliance costs.

  2. How does patent status impact market strategy?
    Patent expirations allow generic manufacturers to introduce lower-cost alternatives, intensifying price competition and eroding margins of branded products.

  3. Are there safety concerns associated with plastic containers for contrast agents?
    Regulatory bodies require plastics to meet biocompatibility standards; no significant safety issues are reported when compliance is maintained.

  4. What role does technological innovation play in market growth?
    Development of pre-filled, single-use plastic syringes enhances safety and convenience, boosting adoption rates.

  5. How might regulatory changes affect future market prospects?
    Stricter safety and environmental regulations may increase production costs but can also favor higher-quality, branded products, potentially strengthening market positions.


References

[1] MarketAndMarkets. (2022). Contrast Media Market by Type, Application, Route of Administration, and Region.
[2] Smith, J., & Lee, S. (2021). Trends in Contrast Media Packaging and Distribution. Journal of Medical Packaging, 37(4), 120-127.

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