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Last Updated: December 19, 2025

POTASSIUM CHLORIDE IN PLASTIC CONTAINER Drug Patent Profile


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When do Potassium Chloride In Plastic Container patents expire, and what generic alternatives are available?

Potassium Chloride In Plastic Container is a drug marketed by Fresenius Kabi Usa and is included in two NDAs.

The generic ingredient in POTASSIUM CHLORIDE IN PLASTIC CONTAINER is potassium chloride. There are two hundred and forty drug master file entries for this compound. Eighty-six suppliers are listed for this compound. Additional details are available on the potassium chloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Potassium Chloride In Plastic Container

A generic version of POTASSIUM CHLORIDE IN PLASTIC CONTAINER was approved as potassium chloride by ACTAVIS LABS FL INC on April 10th, 2002.

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Summary for POTASSIUM CHLORIDE IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 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
Fresenius Kabi Usa POTASSIUM CHLORIDE IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 088901-001 Jan 25, 1985 AP RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Fresenius Kabi Usa POTASSIUM CHLORIDE IN PLASTIC CONTAINER potassium chloride INJECTABLE;INJECTION 088908-001 Jan 25, 1985 AP RX 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 Potassium Chloride in Plastic Containers

Last updated: August 1, 2025


Introduction

Potassium chloride (KCl) pharmaceuticals form a crucial segment within electrolyte replacement and correction therapies. The formulation of potassium chloride in plastic containers has seen notable growth driven by expanding clinical applications, manufacturing innovations, and evolving regulatory environments. This analysis delineates the current market dynamics, forecasted growth trajectories, and key factors influencing the financial outlook for potassium chloride packaged in plastic containers.


Market Overview

Potassium chloride is primarily used to treat and prevent low blood potassium levels (hypokalemia), with applications extending into dialysis, cardiac care, and nutritional supplementation. The shift toward plastic containers—mainly polyethylene or polypropylene—stems from safety, cost-effectiveness, and logistic advantages over glass packaging, including reduced breakage risks and enhanced shelf life.

The pharmaceutical packaging landscape indicates a significant pivot from traditional glass vials to plastic containers. According to a report by Grand View Research, the global pharmaceutical packaging market is projected to reach USD 125.3 billion by 2028, expanding at a CAGR of 8.0% from 2021 to 2028. The segment involving liquid pharmaceuticals, including potassium chloride solutions, commands a substantial share, driven by patient safety and accessibility priorities.


Key Market Drivers

  1. Rising Incidence of Chronic Diseases
    An aging population worldwide has increased the prevalence of chronic kidney disease (CKD) and cardiac disorders, heightening demand for electrolyte management solutions. The Global Burden of Disease study highlights a 30% increase in CKD cases over the past decade, underpinning steady demand for potassium chloride therapies.

  2. Advancement in Packaging Technologies
    Plastic containers offer advantages such as ease of handling, disposability, and compatibility with various infusion systems. Innovations like pre-filled, ready-to-use plastic bottles with tamper-evidence and child-proof caps align with modern safety standards, fostering market expansion.

  3. Regulatory and Safety Considerations
    Stringent safety and quality requirements, including contamination prevention and light protection, favor the adoption of plastic packaging. Moreover, the durability of plastic packaging reduces product loss during transportation and storage, influencing manufacturers’ packaging choices.

  4. Cost Optimization
    Plastic containers typically reduce manufacturing and logistics costs relative to glass, incentivizing pharmaceutical companies to adopt them at scale, especially in emerging markets.


Market Challenges

  • Material Compatibility and Stability
    Concerns regarding the interaction between potassium chloride solutions and plastic materials necessitate rigorous validation. Some plastics may permeate or leach substances, posing regulatory hurdles.

  • Environmental Impact and Sustainability
    The push toward eco-friendly packaging options imposes challenges relating to plastic waste management and recyclability. Regulatory bodies and consumers are increasingly favoring biodegradable and recyclable materials, influencing formulation designs.

  • Regulatory Variability
    Different jurisdictions impose diverse standards for plastic container safety, influencing market entry strategies and compliance costs.


Financial Trajectory and Forecasting

Market Size and Revenue Trends

The global market for potassium chloride in liquid form (primarily supplied in plastic containers) is projected to grow from approximately USD 400 million in 2022 to over USD 600 million by 2030, reflecting a compound annual growth rate (CAGR) of approximately 5.5%. This growth rate exceeds the broader pharmaceutical packaging CAGR, attributable to the increasing clinical adoption and improved packaging technologies.

Regional Market Insights

  • North America dominates, driven by high healthcare expenditure, advanced infrastructure, and established clinical practices. The US accounts for nearly 40% of revenue, with growth driven by aging demographics and regulatory advances promoting safety.
  • Europe showcases steady demand, with countries like Germany and the UK emphasizing safety standards and environmental sustainability.
  • Asia-Pacific presents the highest growth potential, projected to expand at a CAGR exceeding 7%. Rapid urbanization, healthcare expansion, and manufacturing capacity boosts underpin this trajectory.

Technology and Innovation Impact

Investment in smart packaging—such as integrated dosing counters and tamper-evident seals—is expected to add to the initial capital expenditure but improves market acceptability, premium positioning, and patient safety, thereby enhancing revenue streams.

Pricing Trends

Pricing for potassium chloride in plastic containers is expected to experience moderate increases aligned with raw material costs (notably polypropylene and polyethylene), manufacturing efficiencies, and regulatory compliance expenses. Nonetheless, economies of scale in large-volume manufacturing are expected to exert downward price pressures, balancing revenue growth.


Market Players and Competitive Landscape

Major players like Baxter International, B.Braun, and Pfizer dominate with established product lines, robust distribution networks, and ongoing innovation. Emerging manufacturers are developing environmentally sustainable container designs to gain market share, responding to regulatory and consumer pressures. Strategic acquisitions and R&D investments are common to sustain competitive advantage.


Regulatory Landscape

The US FDA and EMA govern device and packaging safety standards, emphasizing compatibility, leachables, and the integrity of pharmaceutical containers. Recent updates prioritize sustainability and environmental impact assessments, influencing future packaging designs.


Future Outlook

The financial outlook for potassium chloride in plastic containers is optimistic, with steady growth fueled by technological advancement, increasing clinical applications, and growing global healthcare access. The transition towards environmentally sustainable packaging is expected to influence product development, innovation investments, and regulatory pathways, shaping the market's long-term trajectory.


Key Factors Influencing Financial Success

  • Adoption of innovative, eco-friendly plastics that meet strict regulatory standards.
  • Expansion into emerging markets with sizable healthcare infrastructure investments.
  • Partnership strategies with medical device and packaging manufacturers to accelerate innovation.
  • Cost control amidst raw material volatility.
  • Navigating regulatory compliance efficiently to minimize market entry delays.

Key Takeaways

  • The market for potassium chloride in plastic containers is poised for consistent growth, driven by rising healthcare demands and packaging innovations.
  • Cost-effectiveness, safety, and environmental sustainability are central to manufacturers’ strategic positioning.
  • Regional dynamics vary, with North America leading and Asia-Pacific offering high growth opportunities.
  • Regulatory landscapes necessitate strict compliance to ensure market access and avoid liabilities.
  • Investing in smart, sustainable packaging solutions can provide competitive advantages and align with evolving safety standards and consumer expectations.

FAQs

1. What factors are driving the shift from glass to plastic containers for potassium chloride pharmaceuticals?
Cost efficiencies, safety considerations (reduction in breakage risk), and compatibility with modern infusion systems are primary drivers of this transition.

2. How does packaging influence the stability and efficacy of potassium chloride solutions?
Properly selected plastics are designed to be inert and barrier-protective, minimizing interactions and leaching, thereby maintaining solution stability and efficacy.

3. What environmental concerns are associated with plastic containers, and how are manufacturers addressing them?
Plastic waste contributes to environmental pollution; manufacturers are adopting recyclable materials, biodegradable plastics, and sustainable manufacturing practices to mitigate impacts.

4. How do regulatory standards affect the development and distribution of potassium chloride in plastic containers?
Regulations mandate comprehensive safety, compatibility, and stability testing, influencing packaging design, validation processes, and overall time to market.

5. What are the emerging technological innovations expected to impact this market?
Smart packaging with integrated dosing mechanisms, tamper-evident features, and environmentally friendly plastics are major innovations poised to influence future market trends.


References

  1. Grand View Research, "Pharmaceutical Packaging Market Size, Share & Trends Analysis," 2022.
  2. Global Burden of Disease Study, 2020.
  3. FDA & EMA regulatory guidelines on pharmaceutical packaging safety and standards.

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