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Last Updated: December 30, 2025

POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Potassium Chloride 0.037% In Dextrose 5% In Plastic Container, and when can generic versions of Potassium Chloride 0.037% In Dextrose 5% In Plastic Container launch?

Potassium Chloride 0.037% In Dextrose 5% In Plastic Container is a drug marketed by B Braun and is included in two NDAs.

The generic ingredient in POTASSIUM CHLORIDE 0.037% 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 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 0.037% 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 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-001 Feb 17, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-019 Feb 17, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-007 Feb 17, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-013 Feb 17, 1988 RX No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 019699-001 Sep 29, 1989 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
B Braun POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-025 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 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER

Last updated: July 27, 2025


Introduction

Potassium chloride 0.037% in dextrose 5% within a plastic container is a critical parenteral electrolyte replenishment formulation predominantly used in clinical settings. This formulation, integral to intravenous therapy, addresses hypokalemia and electrolyte imbalances in hospitalized and outpatient patients. Analyzing its market dynamics and financial trajectory reveals insights into its growth drivers, competitive landscape, and future potential amidst evolving healthcare trends.


Market Overview

The global pharmaceutical market for intravenous (IV) solutions, particularly electrolyte and nutrient infusions, is robust, supported by increasing prevalence of electrolyte disorders, chronic diseases, and the expanding scope of hospital and outpatient care. Potassium chloride solutions constitute a significant segment, owing to their essential role in maintaining cellular functions, cardiac stability, and neuromuscular activity.

The segment characterized by potassium chloride 0.037% in dextrose 5% in plastic containers occupies a niche limited to hospital pharmacies and clinical settings. Its clinical utility combined with advantages such as ease of administration, stability, and reduced infection risk under aseptic manufacturing practices underscore its consistent demand.


Key Market Drivers

1. Growing Prevalence of Electrolyte Imbalances

The rising incidence of electrolyte disturbances driven by aging populations, chronic kidney disease, heart failure, and gastrointestinal losses fuels demand for potassium supplementation. According to the CDC, chronic health conditions such as CKD are accelerating, directly influencing IV electrolyte therapy needs.

2. Expanding Hospital and Outpatient Care Infrastructure

Global healthcare infrastructure expansion, especially in emerging economies, enhances access to advanced IV therapies. Increased adoption of parenteral nutrition regimens in hospitals, clinics, and surgical centers sustains consistent demand.

3. Advancements in Drug Delivery and Packaging

The shift toward prefilled, sterile plastic containers offers advantages like reduced contamination risk, easier handling, and longer shelf life — making this formulation favorable among healthcare providers.

4. Regulatory Approvals and Healthcare Policies

Stringent safety and manufacturing standards mandated by authorities such as the FDA and EMA promote high-quality, reliable formulations. Policy initiatives aimed at reducing healthcare-associated infections (HAIs) indirectly support the use of sealed plastic container formulations.


Market Challenges

1. Pricing and Market Competition

The commoditized nature of electrolyte solutions faces price sensitivities, especially in price-pressured markets. Generic manufacturers dominate, constraining profit margins and incentivizing cost-effective manufacturing.

2. Supply Chain Vulnerabilities

Disruptions in raw material availability, especially potassium salts and plastic packaging components, can hinder steady supply and inflate costs.

3. Alternative Formulations and Administration Routes

Emerging therapies, such as oral potassium supplements and specialized low-volume infusions, may limit growth in specific patient populations.


Financial Trajectory and Market Forecasts

1. Market Size and Growth Rates

The global electrolyte infusion market was valued at approximately USD 3.3 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 4%-6% through 2030, driven by increased hospital admissions and geriatric care needs [1].

Within this, potassium chloride solutions hold a significant share, estimated at over 25%, with specific formulations like 0.037% in dextrose solution expected to mirror this growth pace.

2. Revenue Drivers

  • Hospital procurement contracts: Bulk purchasing agreements for IV fluids provide stable revenue streams.
  • Emerging markets expansion: Increasing healthcare infrastructure in Asia-Pacific, Latin America, and Africa offers substantial revenue potential.
  • Product innovations: Development of ready-to-use, stable formulations in plastic containers bolster sales.

3. Competitive Landscape

Major players include Baxter International, B. Braun Melsungen AG, Fresenius Kabi, and local generic manufacturers. These companies leverage economies of scale, access to procurement channels, and regulatory expertise to capture market share.

4. Pricing Trends

While generic competition exerts downward pressure, value-added innovations, regulatory approvals, and supply chain efficiency are enabling sustained profit margins for leading firms.


Market Trends Impacting Financial Trajectory

a. Product Diversification

Introduction of newer formulations such as dual electrolyte solutions and customizable infusion bags expand market options, catering to tailored patient needs.

b. Regulatory Compliance and Quality Assurance

Stringent quality standards necessitate investments in manufacturing facilities and validation processes, increasing upfront costs but ensuring market access and premium pricing.

c. Digital and Supply Chain Optimization

Utilization of digital platforms for procurement and inventory management enhances cost efficiencies and improves forecast accuracy.


Future Outlook and Strategic Considerations

The trajectory for potassium chloride 0.037% in dextrose 5%, in plastic containers, is optimistic but contingent upon favorable healthcare infrastructure evolution and regulatory climates. Innovations in formulation stability, safety, and delivery methods will serve as key differentiators. Companies focusing on expanding into emerging markets, investing in quality manufacturing, and aligning with healthcare policy shifts will likely experience sustained growth.


Key Challenges and Risks

  • Supply chain disruptions could limit availability, impacting revenue.
  • Pricing pressures in saturated markets threaten margins.
  • Regulatory changes may impose additional compliance costs.
  • Competition from oral potassium supplements and alternative therapies could erode demand in specific settings.

Conclusion

The market for potassium chloride 0.037% in dextrose 5%, delivered via plastic containers, exhibits steady growth, driven by demographic trends, healthcare infrastructure expansion, and product innovation. Companies that strategically navigate supply chain challenges, strengthen regulatory compliance, and capitalize on emerging market opportunities will position themselves for profitable expansion.


Key Takeaways

  • The IV electrolyte market is projected to grow at 4-6% CAGR through 2030 due to rising global healthcare demands.
  • Strategic focus on product innovation, regulatory compliance, and supply chain management will be critical for sustained profitability.
  • Expanding into emerging markets presents significant revenue opportunities owing to increasing healthcare infrastructure.
  • Competitive differentiation hinges on quality manufacturing, packaging advancements, and tailored formulations.
  • Market risks include price competition, supply disruptions, and evolving regulatory landscapes.

FAQs

1. What factors influence the demand for potassium chloride solutions in plastic containers?
Demand is primarily driven by the prevalence of electrolyte imbalances, hospital procurement practices, and the advantages of sealed plastic containers for safety and convenience.

2. How does the market for this formulation compare globally?
While North America and Europe dominate due to advanced healthcare infrastructure, rapid growth is observed in emerging regions like Asia-Pacific and Latin America, driven by expanding hospital networks.

3. What are the main competitors in this market segment?
Major pharmaceutical companies such as Baxter International, B. Braun, and Fresenius Kabi lead the market, complemented by regional generic manufacturers.

4. How do regulatory standards affect market dynamics?
Strict compliance requirements enhance product quality, increasing manufacturing costs but also ensuring market access and consumer safety, ultimately influencing pricing and profitability.

5. What future innovations could impact this market?
Development of more stable formulations, prefilled infusion systems, and tailored electrolyte solutions will shape the market landscape and influence financial trajectories.


Sources

[1] Markets and Markets, "IV Solutions Market," 2022.

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