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Last Updated: December 30, 2025

POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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When do Potassium Chloride 0.22% In Dextrose 5% In Plastic Container patents expire, and what generic alternatives are available?

Potassium Chloride 0.22% In Dextrose 5% In Plastic Container is a drug marketed by B Braun and is included in three NDAs.

The generic ingredient in POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER is dextrose; potassium chloride. There are nine drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the dextrose; potassium chloride profile page.

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Summary for POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% 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 POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-005 Feb 17, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 019699-005 Sep 29, 1989 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-023 Feb 17, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-011 Feb 17, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-017 Feb 17, 1988 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 0.22% in Dextrose 5% in Plastic Container

Last updated: August 4, 2025


Introduction

Potassium chloride (KCl) 0.22% in dextrose 5% in a plastic container represents a critical electrolyte therapy solution widely used in clinical settings for fluid and electrolyte management. Its market trajectory is shaped by a confluence of clinical demand, technological innovation, regulatory frameworks, and competitive forces. This article delineates key market dynamics and forecasts the financial trajectory of this vital pharmaceutical product, providing insights for stakeholders seeking strategic growth opportunities.


Market Overview

Potassium chloride solutions are primarily employed for treating hypokalemia, preventing potassium deficiency during therapy involving diuretics, and managing various electrolyte imbalances. The specific formulation—0.22% KCl in 5% dextrose—serves as a controlled, balanced infusion fluid suitable for intravenous administration, especially suited for outpatient care, hospitals, and long-term care facilities.

The global infusion therapies market, encompassing intravenous fluids like this potassium chloride solution, is projected to grow at a CAGR of approximately 7-8% during 2023-2028, driven by rising incidences of chronic diseases, increasing hospitalizations, and expanding outpatient care services[1].


Market Drivers

1. Rising Incidence of Electrolyte Imbalances

The increasing prevalence of conditions such as chronic kidney disease (CKD), congestive heart failure, and diabetes mellitus is elevating the demand for electrolyte replenishment solutions. The global CKD population alone is expected to reach over 700 million by 2040, surging the need for prophylactic and therapeutic electrolyte solutions like potassium chloride infusions[2].

2. Aging Population and Increased Healthcare Access

Elderly populations are more susceptible to electrolyte disturbances, necessitating reliable infusion therapies. Additionally, expanding healthcare infrastructure in emerging economies enhances access to intravenous treatments, supporting market growth.

3. Technological Advancements and Formulation Optimization

Innovation in infusion device design, plastic container safety standards, and stability enhancements extend product shelf life and reduce contamination risks. These technological improvements favor adoption and facilitate newer formulations.

4. Regulatory Environment

Stringent compliance with safety regulations (e.g., USP, European Pharmacopoeia, FDA guidelines) ensures product quality, encouraging hospital procurement and reinforcing market confidence. Continuous updates to standards regarding infusion fluid composition and container safety further shape market evolution.


Market Challenges

1. Competitive Landscape and Pricing Pressure

The presence of numerous manufacturers, both multinational and regional, exerts downward pressure on pricing. Market consolidation, especially post-pandemic, heightens competition, with some companies engaging in price wars to expand market share.

2. Regulatory and Safety Concerns

Incidents related to contamination, bag integrity breach, or improper formulation can impact market perceptions. Regulatory agencies have intensified scrutiny, requiring stringent quality controls, which might raise manufacturing costs.

3. Supply Chain Constraints

Disruptions in the supply of raw materials like potassium chloride or dextrose, especially amid global geopolitical tensions or pandemics, can hinder manufacturing output and delay procurement cycles.


Financial Trajectory and Market Forecast

1. Revenue Projections

Based on current trends, the global market value for potassium chloride infusion solutions, including 0.22% KCl in dextrose 5%, is projected to reach USD 1.2-1.5 billion by 2028, expanding at a CAGR of approximately 7-8%. Key regional markets such as North America, Europe, and Asia-Pacific will drive growth, with emerging economies exhibiting rapid adoption.

2. Regional Insights

  • North America: Dominating market share (~40%) attributable to advanced healthcare infrastructure, high patient volume for electrolyte replenishment, and high regulatory standards. Predicted steady growth driven by aging demographics and chronic disease prevalence.

  • Europe: A mature but evolving market with stringent regulatory oversight and high awareness of infusion safety; growth primarily fueled by modernization and hospital procurement policies.

  • Asia-Pacific: The fastest-growing segment (~9-10% CAGR), owing to burgeoning healthcare infrastructure, increasing healthcare expenditure, and growing awareness about electrolyte management.

3. Pricing and Profitability

Manufacturers expect to see moderate gross margins (~20-30%), with profitability influenced by manufacturing costs, regulatory compliance expenses, and competitive pricing strategies. Technological innovations and scale economies will be critical to sustaining margins.

4. Strategic Opportunities

  • Generic and Branded Competition: Companies investing in biosimilar or generic formulations will face price-based competition, but differentiation through quality assurance and formulation stability can foster market share.

  • Product Differentiation: Innovations targeting container design for safety, compatibility with infusion devices, or extended shelf-life will create competitive advantages.

  • Partnerships and Market Expansion: Collaborations with healthcare providers and government tenders can unlock new revenue streams.


Future Outlook and Strategic Recommendations

The growth prospects for potassium chloride 0.22% in dextrose 5% in plastic containers are promising, contingent upon continued technological innovations, adherence to safety standards, and strategic penetration into emerging markets. Key focus areas include:

  • Emphasizing product safety and stability improvements.
  • Capitalizing on regional healthcare infrastructure development.
  • Engaging in competitive pricing strategies without compromising quality.
  • Pursuing strategic alliances with healthcare providers and distributors.

Key Takeaways

  • The global infusion therapy market, driven by electrolyte replenishment needs, is set for sustained growth at approximately 7-8% CAGR through 2028.
  • Rising chronic disease prevalence, aging demographics, and healthcare infrastructure expansion underpin demand for potassium chloride infusion solutions.
  • Innovation in formulation, container safety, and cost-efficiency will be pivotal for market players to enhance profitability.
  • Regional dynamics favor North America and Europe in maturity, while Asia-Pacific offers rapid growth opportunities.
  • Competitive and regulatory pressures necessitate focus on quality assurance, safety, and strategic branding to secure market share.

Frequently Asked Questions

1. What are the primary clinical indications for potassium chloride 0.22% in dextrose 5%?
Potassium chloride solutions are essential for managing hypokalemia, preventing potassium deficiency during certain therapies, and maintaining electrolyte balance in hospitalized and outpatient settings.

2. How do technological innovations impact the market for potassium chloride infusion solutions?
Innovations improve stability, safety (such as leak-proof container design), and compatibility with infusion devices, thereby enhancing product adoption and reducing adverse events.

3. What regional trends influence the market trajectory of potassium chloride solutions?
North America leads due to advanced healthcare infrastructure, Europe maintains steady growth through regulatory compliance, while Asia-Pacific exhibits rapid market expansion driven by healthcare development.

4. How do regulatory standards affect the manufacturing and market access for these solutions?
Strict compliance with pharmacopeial standards ensures product quality and safety, facilitating market approval and reducing liability and recalls.

5. What strategic moves can manufacturers adopt to succeed in this competitive landscape?
Investing in product safety, quality improvements, regional market expansion, forming strategic alliances, and offering cost-competitive solutions are vital for sustained growth.


References

[1] MarketsandMarkets. "Infusion Therapy Market by Product, Application, and Region," 2022.

[2] Global Kidney Foundation. "Chronic Kidney Disease and Electrolyte Management," 2021.

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