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Last Updated: December 12, 2025

IOPAMIDOL-370 IN PLASTIC CONTAINER Drug Patent Profile


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When do Iopamidol-370 In Plastic Container patents expire, and when can generic versions of Iopamidol-370 In Plastic Container launch?

Iopamidol-370 In Plastic Container is a drug marketed by Hospira and is included in one NDA.

The generic ingredient in IOPAMIDOL-370 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-370 In Plastic Container

A generic version of IOPAMIDOL-370 IN PLASTIC CONTAINER was approved as iopamidol by HAINAN POLY on February 27th, 2023.

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Summary for IOPAMIDOL-370 IN PLASTIC CONTAINER
Drug patent expirations by year for IOPAMIDOL-370 IN PLASTIC CONTAINER
Recent Clinical Trials for IOPAMIDOL-370 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-370 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-370 IN PLASTIC CONTAINER iopamidol INJECTABLE;INJECTION 074636-004 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 Iopamidol-370 in Plastic Container

Last updated: July 30, 2025


Introduction

The pharmaceutical sector continually evolves with innovations aimed at improving drug delivery, safety, and patient compliance. Iopamidol-370, a contrast agent used in medical imaging, particularly in computed tomography (CT) scans, exemplifies recent advancements. Its transition into pre-filled plastic containers signifies an important shift, influencing market dynamics, manufacturing efficiencies, and financial performance. This analysis assesses the current market landscape, growth drivers, challenges, and financial trajectory for Iopamidol-370 in plastic containers.


Market Overview

Iopamidol-370 is an iodinated radiocontrast agent primarily used to enhance imaging clarity in diagnostic procedures. As a third-generation contrast agent, it offers improved safety profiles over older formulations, with a reduced risk of adverse reactions [1]. Traditionally, the drug was supplied in glass vials; however, shifting towards plastic containers aims to enhance safety, storage efficiency, and ease of administration.

The global contrast media market is projected to grow at a CAGR of approximately 6.5% through 2028, driven by rising prevalence of chronic diseases requiring diagnostic imaging, technological advancements, and increased healthcare infrastructure investments [2]. Iopamidol, retailing in various concentrations, notably 370 mg/mL, constitutes a significant share of this market owing to its widespread clinical utility.


Market Dynamics

1. Drivers

  • Rising Demand for Diagnostic Imaging
    An ageing population globally, coupled with increasing incidences of cardiovascular, oncological, and neurological diseases, propels demand for contrast agents like Iopamidol-370. The growth in outpatient imaging procedures further fuels market expansion [3].

  • Innovations in Drug Delivery
    The shift from glass vials to plastic containers facilitates safer handling, reduces breakage, and streamlines administration. Pre-filled plastic syringes and containers encourage faster deployment in acute settings, enhancing operational efficiency and patient safety.

  • Regulatory Favorability
    Regulatory agencies favor innovations that mitigate risks, such as glass fragment contamination. The integration of plastic containers aligns with safety protocols, easing approval processes and fostering market acceptance.

  • Manufacturing and Cost Advantages
    Plastic containers reduce manufacturing costs associated with glass production, sterilization, and disposal burdens. These savings are transferred downstream, offering more competitive pricing models.

2. Challenges

  • Regulatory and Safety Concerns
    The migration of plastic materials into pharmaceuticals raises concerns over leachates and stability. Ensuring compliance with stringent quality standards, such as those set by the FDA and EMA, infers rigorous testing and validation costs.

  • Market Penetration Barriers
    Established supply chains and vendor relationships for glass bottles create inertia against transition. Additionally, validation of compatibility between plastic formulations and drug stability remains crucial.

  • Environmental Impact
    Although plastics offer logistical benefits, environmental concerns over plastic waste and pollution pose regulatory and societal challenges, potentially impacting adoption.


Financial Trajectory

1. Revenue Projections

The deployment of Iopamidol-370 in plastic containers is likely to boost sales volume growth by improving product safety and accessibility. Market analysts forecast a compound annual growth rate (CAGR) of 7-9% over the next five years for contrast agents in pre-filled plastic formats, potentially increasing Iopamidol-370 sales revenues proportionally [4].

2. Cost Structure and Profitability

Transitioning to plastic containers entails upfront investment in new manufacturing lines, validation studies, and quality assurance protocols. However, these are offset over time by reduced material costs, streamlined logistics, and enhanced product differentiation. Margins may improve as the plastic format gains acceptance, especially in high-volume markets like North America and Europe.

3. Competitive Positioning

Major players such as Bracco Imaging, GE Healthcare, and Bayer have initiated transitions toward plastic container formats for contrast agents, seeking to capture health system efficiency gains and improve patient outcomes. Proactive adaptation positions manufacturers favorably within an increasingly health-conscious and safety-oriented marketplace.

4. Regulatory Impact

Easing of regulatory pathways, driven by safety improvements related to plastic packaging, can accelerate market entry and product launches. Conversely, delays due to regulatory scrutiny can impact financial projections, underscoring the importance of comprehensive validation and documentation.


Market Opportunities

  • Emerging Market Penetration
    Developing regions present significant growth opportunities due to increasing healthcare infrastructure and rising diagnostic imaging volumes. Light-weight, portable plastic containers facilitate broader distribution.

  • Product Line Extensions
    The integration of Iopamidol-370 into multi-dose or pre-filled disposable systems aligns with trends toward convenience and infection control, creating new revenue streams.

  • Partnerships and Collaborations
    Strategic alliances between manufacturers and packaging firms can accelerate innovation cycles and reduce time-to-market, positively influencing long-term financial performance.


Risks and Mitigation

  • Supply Chain Disruptions
    Reliance on plastic raw materials mandates resilient sourcing strategies. Inventory buffers and supplier diversification can mitigate risks.

  • Technological Failures
    Ensuring compatibility and stability of the drug in plastic containers requires rigorous validation. Investing in research and development curtails the risk of product recalls or negative market perception.

  • Regulatory Setbacks
    Early engagement with regulatory authorities and adherence to strict quality standards help preempt delays and compliance issues.


Conclusion

The integration of Iopamidol-370 into plastic containers signifies a strategic evolution aligned with safety, efficiency, and market demand trends. This shift is anticipated to generate favorable financial trajectories driven by enhanced sales volumes, cost efficiencies, and market penetration. Nevertheless, companies must navigate regulatory complexities, environmental considerations, and technological validation to fully capitalize on growth opportunities.


Key Takeaways

  • The transition to plastic containers positions Iopamidol-370 favorably within a growing contrast media market driven by diagnostic imaging demand.
  • Cost efficiencies and safety benefits bolster the financial outlook, with projected CAGR of 7-9% over five years.
  • Market expansion into emerging regions and product line extensions offer substantial growth avenues.
  • Achieving regulatory approval hinges on demonstrated compatibility, stability, and safety of plastic packaging.
  • Strategic collaborations and investment in validation processes are essential to mitigate risks and accelerate market adoption.

FAQs

1. What are the primary advantages of packaging Iopamidol-370 in plastic containers?
Plastic containers offer safety benefits by reducing breakage risk, simplifying logistics, enabling pre-filled and easy-to-use dosing formats, and lowering manufacturing costs. They also improve patient safety by minimizing contamination risks associated with glass.

2. How does the shift to plastic packaging impact regulatory approval processes?
Regulators require comprehensive validation to demonstrate stability, compatibility, and absence of harmful leachates. While initial validation may delay time-to-market, successful approval facilitates wider adoption and commercialization.

3. What are the environmental considerations associated with plastic containers for pharmaceuticals?
Plastic packaging raises concerns over waste and pollution. Industry efforts focus on developing recyclable plastics and environmentally sustainable disposal methods to mitigate ecological impacts.

4. Which regions are expected to benefit most from the adoption of Iopamidol-370 in plastic containers?
Developed markets such as North America and Europe will likely lead adoption due to existing infrastructure and regulatory familiarity, with emerging markets providing substantial growth opportunities due to expanding healthcare access.

5. How do manufacturing cost savings influence the pricing strategy for Iopamidol-370?
Reduced material and logistics costs allow manufacturers to offer competitive pricing, potentially increasing market share and enhancing profitability, especially in price-sensitive markets.


References

[1] Market Research Future, "Contrast Media Market – Forecast to 2028," 2021.
[2] Grand View Research, "Contrast Media Market Size & Share," 2022.
[3] World Health Organization, "Global Diagnostic Imaging Trends," 2020.
[4] Deloitte Insights, "Medical Imaging Market Outlook," 2022.

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