Last Updated: May 4, 2026

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
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
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 ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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: March 14, 2026

What are the key market drivers influencing demand?

The primary drivers for potassium chloride (KCl) 0.037% in dextrose 5% in plastic containers include its use in intravenous (IV) therapy, electrolyte replenishment, and fluid management in hospitals and clinics. The increasing prevalence of chronic diseases such as renal failure, gastrointestinal disorders, and cardiac conditions sustains steady demand in hospital settings.

The global rise in surgeries and healthcare infrastructure development, especially in emerging economies, enhances market reach. The expanding geriatric population, prone to electrolyte imbalances, further contributes to demand growth. The drug's formulation in plastic containers aligns with safety standards, ease of handling, and sterilization requirements, supporting market stability.

How does the competitive landscape affect pricing and adoption?

Key manufacturers include Baxter International, B. Braun Melsungen AG, Fresenius Kabi, and Hikma Pharmaceuticals. These firms participate in a competitive environment characterized by:

  • Strategic partnerships with hospitals and healthcare providers.
  • Differentiated formulations targeting specific patient needs.
  • Investment in manufacturing capacities aligned with regulatory standards.

Market prices are influenced by raw material costs, regulatory compliance costs, and manufacturing scale efficiency. Economies of scale enable large producers to offer more competitive pricing, impacting newer entrants' market penetration.

What regulatory factors influence market approval and sales?

Regulatory approval is fundamental. Agencies like the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and local regulators require evidence of safety, efficacy, and quality controls.

Key policies include:

  • Good Manufacturing Practices (GMP) compliance.
  • Stability testing for specific formulations.
  • Labeling and packaging regulations to ensure safety and traceability.

Variations in regulatory timelines can delay market entry and influence financial forecasts.

What are the revenue expectations and growth prospects?

The global IV fluids market, which includes potassium chloride solutions, was valued at approximately USD 7.9 billion in 2021, with a compound annual growth rate (CAGR) of 4.5% forecast through 2028 [1].

Potassium chloride solutions represent a significant share, driven by hospital demand. The specific segment of potassium chloride 0.037% in dextrose 5% in plastic containers is projected to grow at the same CAGR, assuming continuous hospital dependence and expanding healthcare infrastructure.

Pricing benchmarks suggest:

Region Typical Price (USD per unit) Notes
North America USD 0.50 – USD 1.00 Volume discounts apply
Europe USD 0.45 – USD 0.90 Regulatory factors influence pricing
Asia-Pacific USD 0.30 – USD 0.75 Lower manufacturing costs

Projected revenues depend on factors such as average sales price, market share, and hospital procurement volume.

How does raw material and manufacturing capacity influence profitability?

Raw material costs for potassium chloride and dextrose directly affect margins. Market prices for bulk potassium chloride fluctuate based on global supply-demand dynamics.

Manufacturing capacity investments enable cost efficiencies. Larger players have capacity for high-volume production, which drives down per-unit costs. Regulatory compliance costs involve GMP certification, quality-assurance testing, and packaging standards, adding to operational expenses.

What risks could impact the financial outlook?

  • Regulatory delays or restrictions.
  • Supply chain disruptions affecting raw material availability.
  • Pricing pressures from generic competitors.
  • Changes in healthcare policies or reimbursement models.

Any of these could reduce profit margins or slow revenue growth.

Key Takeaways

  • Demand driven by clinical necessity, aging populations, and healthcare infrastructure expansion.
  • Competitive environment shaped by large manufacturers with scale advantages.
  • Regulatory compliance is critical; delays impact market entry and revenue.
  • Revenue growth aligns with the global IV fluids market CAGR (~4.5%).
  • Profitability is influenced by raw material costs and manufacturing efficiencies.

FAQs

  1. What are the main application areas for potassium chloride 0.037% in dextrose 5%?
    Mainly used in intravenous therapy for electrolyte replenishment and fluid management in hospitals.

  2. How do regulatory standards impact market entry?
    They require compliance with GMP, safety testing, and proper labeling, which can cause delays and increase costs.

  3. Is the market saturated?
    The market remains competitive but not saturated; growth is driven by healthcare needs and capacity expansion in emerging markets.

  4. What are the key cost components?
    Raw materials, manufacturing processes, regulatory compliance, and packaging.

  5. What is the future outlook?
    Moderate growth aligned with the overall IV fluids market, supported by healthcare infrastructure growth and technological advancements in drug delivery.


References

[1] MarketWatch. (2022). IV Fluids Market Size, Share & Trends Analysis Report. Retrieved from https://www.marketwatch.com/

[2] Grand View Research. (2022). Intravenous (IV) Fluids Market Size, Share & Trends. Retrieved from https://www.grandviewresearch.com/

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