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Last Updated: December 12, 2025

SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Sodium Chloride 0.9% And Potassium Chloride 0.22% In Plastic Container, and when can generic versions of Sodium Chloride 0.9% And Potassium Chloride 0.22% In Plastic Container launch?

Sodium Chloride 0.9% And Potassium Chloride 0.22% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% 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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  • What is the 5 year forecast for SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER?
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Summary for SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
Drug patent expirations by year for SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER

US Patents and Regulatory Information for SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% 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
B Braun SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 018722-003 Nov 9, 1982 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 Sodium Chloride 0.9% and Potassium Chloride 0.22% in Plastic Containers

Last updated: August 4, 2025


Introduction

The combination of Sodium Chloride 0.9% and Potassium Chloride 0.22% in plastic containers constitutes a vital formulation widely used in intravenous therapy, primarily for fluid and electrolyte replenishment. Their market trajectory is shaped by evolving medical needs, technological advancements, manufacturing trends, and regulatory environments. This analysis examines market dynamics, growth drivers, challenges, and financial prospects associated with these electrolyte solutions.


Market Overview

The global electrolyte solutions market, encompassing sodium chloride and potassium chloride formulations, is projected to experience sustained growth driven by increasing hospital admissions, rising prevalence of chronic diseases, and expanding surgical procedures. The specific segment of Sodium Chloride 0.9% and Potassium Chloride 0.22% in plastic containers caters primarily to hospitals, clinics, and emergency care centers requiring sterile, ready-to-use intravenous solutions.


Market Dynamics

1. Driving Factors

a. Rising Healthcare Expenditure and Hospitalizations:
Global healthcare expenditure expansion correlates with increased hospital admissions, where electrolyte solutions are critical for managing dehydration, electrolyte imbalances, and fluid therapy. The World Bank reports increased healthcare investments across emerging economies, fueling demand [1].

b. Prevalence of Chronic and Acute Conditions:
Chronic diseases, notably renal failure, heart failure, and electrolyte disorders, necessitate continual electrolyte monitoring and replacement, elevating demand for sodium and potassium chloride solutions. The American Kidney Foundation highlights the increasing burden of kidney disease driving IV electrolyte therapy [2].

c. Growth in Surgical Procedures:
Electrolyte imbalance management during and post-surgery remains essential. The rise in minimally invasive and outpatient surgeries propels the need for pre- and post-operative electrolyte hydration solutions.

d. Advancements in Manufacturing and Packaging Technologies:
Development of sterile, ready-to-use plastic container formats enhances safety, convenience, and shelf life, driving adoption in clinical settings. The preference for plastic over glass containers aligns with safety and cost-effectiveness considerations.

e. Regulatory Approvals and Quality Standards:
Stringent compliance with pharmacopeial standards (USP, EP) ensures safety and efficacy, bolstering market confidence and expansion.

2. Restraints and Challenges

a. Competition from Generic and Alternative Formulations:
Market saturation with generic electrolyte solutions exerts pricing pressure. Additionally, newer formulations like buffered solutions or those with added nutrients may compete for market share.

b. Price Volatility of Raw Materials:
Fluctuations in sodium chloride and potassium chloride raw material prices influence manufacturing costs. Supply chain disruptions can affect availability and costs.

c. Stringent Regulatory Surveillance:
Product approvals, post-market surveillance, and compliance impose costs and delays, hindering rapid market entry or expansion.

d. Limited Differentiation:
Electrolyte solutions are relatively homogenous commodities, which restricts competitive differentiation solely based on formulation. Innovation focus on packaging, delivery systems, and adjunct features becomes critical.


Financial Trajectory and Market Forecasts

1. Market Size and Growth Projections

The global intravenous (IV) solutions market was valued at approximately USD 10 billion in 2022, with electrolyte solutions accounting for a significant share. The segment specifically comprising Sodium Chloride 0.9% and Potassium Chloride 0.22% in plastic containers is projected to grow at a CAGR of 5-7% over the next five years, driven by expanding healthcare infrastructure and technological innovation [3].

2. Geographical Market Insights

  • North America: Dominates due to high healthcare spending, advanced medical infrastructure, and regulatory standards. The U.S. market alone is estimated to account for over 40% of the global electrolyte solutions market.
  • Europe: Progressive healthcare systems and stringent regulatory frameworks bolster market stability.
  • Emerging Markets: Countries such as China and India exhibit rapid market expansion owing to increasing healthcare initiatives, urbanization, and expanding hospital networks.

3. Commercial Trends

a. Mergers and Acquisitions:
Major players, including Baxter International, Hospira (a Pfizer spinoff), and B. Braun, pursue consolidation to enhance manufacturing capacity, diversify product portfolios, and improve distribution networks.

b. Innovation and Differentiation:
Investments in formulation stability, container materials, and smart infusion systems create new revenue streams and competitive edges.

c. Supply Chain Optimization:
Manufacturers are adopting lean supply chain models to mitigate raw material costs and enhance delivery efficiency, impacting profit margins positively.


Regulatory and Market Challenges

Regulatory bodies, including the FDA and EMA, enforce stringent testing and quality standards, impacting time-to-market and compliance costs. Recent global disruptions, such as COVID-19, strained supply chains, leading to increased raw material costs and bottlenecks, affecting profit margins. Furthermore, increasing scrutiny of sterile manufacturing practices and quality assurance processes necessitates continuous investment.


Future Outlook and Strategic Opportunities

The outlook remains optimistic, with anticipated innovations in container materials, such as biodegradable plastics, and integration with smart infusion systems, offering differentiation. The rising focus on personalized medicine and home infusion therapy presents growth avenues. Companies investing in R&D, supply chain resilience, and regulatory engagement are strategically positioned for profitable expansion.


Key Market Drivers

  • Growing healthcare infrastructure investment.
  • Rising prevalence of electrolyte-depleting conditions.
  • Technological advances in container and infusion system design.
  • Increased hospital and outpatient procedure volume.

Key Market Challenges

  • Market commoditization and pricing pressures.
  • Stringent regulatory and quality compliance requirements.
  • Raw material price volatility.
  • Competition from alternative formulations and delivery mechanisms.

Key Takeaways

  • The electrolyte solution market, especially Sodium Chloride 0.9% and Potassium Chloride 0.22% in plastic containers, is poised for steady growth driven by global healthcare expansion and technological innovation.
  • Manufacturers should focus on differentiation through packaging, safety features, and integration with advanced infusion systems.
  • Strategic positioning in emerging markets offers high growth potential, provided regulatory and supply chain challenges are adeptly managed.
  • Cost management, raw material sourcing, and compliance are critical to maintain profitability amid competitive pressures.
  • Continued innovation targeted at stability, safety, and user convenience will underpin sustainable growth.

FAQs

1. What factors influence the pricing of Sodium Chloride and Potassium Chloride solutions?
Pricing is influenced by raw material costs, manufacturing expenses, regulatory compliance, distribution logistics, and market competition.

2. How is technological innovation impacting the market for these electrolyte solutions?
Innovations such as advanced sterilization, smart infusion systems, and biodegradable packaging improve safety, convenience, and shelf-life, enhancing market competitiveness.

3. What are the primary regulatory considerations for manufacturers?
Manufacturers must adhere to standards set by bodies like the FDA and EMA, including good manufacturing practices (GMP), stability testing, and quality assurance.

4. How does market competition affect product differentiation?
Given the homogeneity of electrolyte solutions, differentiation is shifting towards packaging innovation, safety features, and integration with infusion technologies rather than formulation variation.

5. What are emerging market opportunities for growth?
Growing healthcare infrastructure in Asia-Pacific, increasing demand in home infusion therapy, and the development of eco-friendly container materials present significant expansion opportunities.


References

[1] World Bank. Global Healthcare Expenditure Data, 2022.
[2] American Kidney Foundation. Kidney Disease Facts and Figures, 2022.
[3] MarketsandMarkets. Intravenous Solutions Market Forecast, 2023-2028.

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