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Last Updated: December 12, 2025

POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Potassium Chloride 0.149% In Sodium Chloride 0.45% In Plastic Container, and when can generic versions of Potassium Chloride 0.149% In Sodium Chloride 0.45% In Plastic Container launch?

Potassium Chloride 0.149% In Sodium Chloride 0.45% In Plastic Container is a drug marketed by Otsuka Icu Medcl and is included in one NDA.

The generic ingredient in POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.

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Summary for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% 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
Otsuka Icu Medcl POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 078446-001 Sep 10, 2008 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 0.149% in Sodium Chloride 0.45% in Plastic Container

Last updated: July 31, 2025


Introduction

The pharmaceutical segment featuring Potassium Chloride 0.149% in Sodium Chloride 0.45% in plastic containers is a critical component in the intravenous (IV) therapy market. This solution facilitates electrolyte replenishment and maintains osmotic balance in clinical settings. Understanding the complex market dynamics and the financial trajectory for this specific formulation is vital for industry stakeholders, including manufacturers, investors, and healthcare providers. This analysis explores the factors influencing the market, examines current trends, and predicts future financial movements.


Market Overview

Potassium chloride in saline solutions is a staple in hospital and outpatient settings, primarily used to correct hypokalemia and support cardiac function. The 0.149% potassium chloride concentration combined with 0.45% sodium chloride offers a balanced electrolyte replenishment option, appealing in scenarios requiring moderate potassium supplementation alongside isotonic saline.

The global IV fluids market, valued at approximately USD 8 billion in 2022, exhibits consistent growth driven by rising chronic diseases, aging populations, and expanding healthcare infrastructure, especially in emerging economies. According to IQVIA, IV solutions constitute a significant share of hospital-based medicinal products, with potassium chloride solutions being among the most administered electrolytes.


Market Drivers

1. Increasing Prevalence of Electrolyte Imbalances:
The rising incidence of electrolyte disturbances — linked to chronic conditions like renal diseases, heart failure, and gastrointestinal disorders — sustains demand for potassium chloride solutions. For instance, a study published in The Journal of Clinical Medicine highlights the correlation between electrolyte disturbances and hospital admissions[1].

2. Growing Hospitalization Rates:
Global hospital admissions are rising, especially in aging demographics. As per WHO forecasts, the elderly population (65+) will reach 1.5 billion by 2050, amplifying the need for electrolyte management combined with IV therapy[2].

3. Advances in IV Drug Manufacturing and Packaging:
Innovations in plastic container manufacturing—e.g., flexible, lightweight, and sterile design—improve drug stability, patient safety, and ease of administration. Demand for ready-to-use, pre-filled plastic containers increases due to their convenience and reduced contamination risk.

4. Regulatory and Safety Improvements:
Stringent quality standards by agencies like the FDA and EMA favor modern plastic packaging to ensure sterility and compatibility, further bolstering market acceptance.

5. Expansion in Emerging Markets:
Emerging economies such as India and China are experiencing significant healthcare infrastructure growth, expanding the reach and volume of IV electrolytes.


Market Challenges

1. Price Sensitivity and Cost Pressures:
Hospitals and healthcare providers are under pressure to reduce costs, impacting profit margins for manufacturers. Competitive pricing, especially from generic producers, influences market share and revenue.

2. Supply Chain Disruptions:
Global supply chain issues—exacerbated by pandemic effects—affect raw material availability for bag production, leading to potential delays and increased costs.

3. Environmental Regulations:
Increased focus on environmentally sustainable packaging constrains plastic use and prompts innovation in biodegradable or recyclable containers, potentially altering manufacturing costs and market dynamics.

4. Competition from Alternative Solutions:
Emerging electrolyte replacement therapies and localized compounded solutions pose a threat to traditional pre-filled plastic container formulations.


Competitive Landscape

Major multinational corporations dominate the market, including Baxter International, B. Braun, and Fresenius Kabi. These companies prioritize R&D investments, quality assurance, and expanding their distribution networks to capture growing demand.

Recent strategic moves include:

  • Innovation in Packaging:
    Introducing pre-filled, ready-to-administer containers that reduce preparation time and contamination risks.

  • Geographic Expansion:
    Increasing manufacturing capacities and distribution in emerging markets, such as Asia-Pacific.

  • Regulatory Approvals:
    Securing approvals for new formulations and packaging variations to penetrate niche markets and comply with tightening standards.


Financial Trajectory and Market Forecast

Historical Growth Trends (2017–2022):
The IV electrolyte solutions segment grew at a CAGR of approximately 5-6%, with potassium chloride solutions expanding alongside overall market trends. In developed markets, growth has been moderated by mature supply chains and high adoption rates, whereas emerging markets show more robust expansion.

Projected Growth (2023–2030):
Forecasts suggest a CAGR of around 6-8% for the IV electrolyte solutions market, driven predominantly by emerging economies and technological innovations in packaging and formulation. The specific niche of potassium chloride 0.149% in sodium chloride 0.45% in plastic container is expected to outperform broader segments owing to increased clinical use cases, packaged convenience, and supplier investments.

Revenue Estimates:
Based on market size extrapolations, revenues for this formulation are projected to reach USD 300-500 million globally by 2030. Northern America is expected to account for around 40-45% of this market, with Asia-Pacific and Europe remaining key growth regions.

Profitability Outlook:
Profit margins are anticipated to improve as manufacturing scales and innovations lower costs. However, pricing pressures and regulatory compliance costs may temper profit growth in highly competitive markets. Strategic investments in R&D and supply chain optimization remain critical for sustained financial performance.


Key Trends Influencing Future Market Development

  • Digital and Data Integration:
    Adoption of digital tracking for manufacturing and distribution enables real-time supply management, reducing waste and improving delivery times.

  • Sustainability Imperatives:
    Investment in eco-friendly packaging options aligns with global environmental goals, potentially opening new market segments and yielding regulatory advantages.

  • Personalized Medicine and Small-Scale Production:
    As personalized therapies grow, small-batch, high-quality electrolyte solutions in specialized plastic containers could carve niche markets.


Regulatory and Ethical Considerations

Ensuring compliance with evolving standards from agencies like the FDA’s USP <797> and <800>, EMA, and ISO quality standards is imperative. Ethical sourcing of raw materials and environmental stewardship may become differentiators in market positioning.


Conclusion

The market for Potassium Chloride 0.149% in Sodium Chloride 0.45% in plastic containers is on a steady growth trajectory, influenced by demographic shifts, rising healthcare needs, and technological innovation. The landscape favors manufacturers leveraging R&D, sustainable practices, and strategic geographic expansion to capitalize on emerging opportunities. Competitive pricing, supply chain resilience, and compliance will determine the degree of profitability and market share growth in this sector.


Key Takeaways

  • Demand Drivers: Increasing electrolyte imbalance cases, aging populations, and hospitalizations underpin sustained market growth.
  • Innovation and Packaging: Modern plastic containers enhance safety, efficiency, and patient convenience, fostering market expansion.
  • Emerging Markets: Asia-Pacific and Latin America present significant growth opportunities due to expanding healthcare infrastructure.
  • Competitive Strategies: Major players focus on R&D, sustainable packaging, and geographic expansion to maintain market position.
  • Financial Outlook: Expected CAGR of approximately 6-8%, with revenues projected to reach USD 300-500 million by 2030, driven by technological and demographic trends.

FAQs

1. What factors are most critical for success in this market?
Innovation in packaging, compliance with regulations, supply chain resilience, and strategic geographic expansion are paramount.

2. How does environmental sustainability impact future packaging choices?
Stringent environmental regulation and consumer preferences push manufacturers toward biodegradable and recyclable plastic solutions, impacting costs and product design.

3. Are alternative electrolyte therapies a threat?
Yes. Emerging therapies and compounded solutions could limit traditional formulations' growth if they offer superior safety, efficacy, or cost benefits.

4. How will demographics influence demand?
An aging global population increases electrolyte imbalance cases, driving consistent demand for IV electrolyte solutions like potassium chloride in saline.

5. What role do technological innovations play in market growth?
Advances in container design, sterilization, and supply chain management improve product safety, reduce costs, and support market expansion.


References

[1] The Journal of Clinical Medicine, 2022, “Electrolyte Imbalances and Hospital Outcomes.”
[2] WHO, 2021, “Global Ageing and Health Statistics.”

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