Last Updated: May 4, 2026

POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Potassium Chloride 0.3% In Dextrose 5% In Plastic Container, and when can generic versions of Potassium Chloride 0.3% In Dextrose 5% In Plastic Container launch?

Potassium Chloride 0.3% 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 0.3% 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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  • What is the 5 year forecast for POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What are the global sales for POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER?
Summary for POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 0.3% 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 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-006 Feb 17, 1988 RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 019699-006 Sep 29, 1989 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-024 Feb 17, 1988 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-012 Feb 17, 1988 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-018 Feb 17, 1988 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 018744-004 Nov 9, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 019630-030 Feb 17, 1988 AP 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 0.3% in Dextrose 5% in Plastic Container

Last updated: February 15, 2026


What is the current market size and growth rate for potassium chloride in dextrose solutions?

The global market for intravenous (IV) potassium chloride, including formulations like 0.3% in 5% dextrose, is projected to grow at a compound annual growth rate (CAGR) of approximately 4.2% from 2022 to 2028. As of 2022, the market size was valued around $400 million, with growth driven by the increasing prevalence of electrolyte imbalances, chronic kidney disease, and GOP in hospitals.

Regional demand exceeds $200 million in North America, with Asia-Pacific and Europe each contributing roughly $100 million. The demand is highest in hospital settings, especially in intensive care units (ICUs) for managing hypokalemia.


What are the key drivers influencing demand for this formulation?

Growing Prevalence of Electrolyte Imbalances

Chronic diseases, especially kidney failure and gastrointestinal disorders, require electrolyte replacement therapies. Potassium chloride is a frontline treatment for hypokalemia, especially in hospital settings.

Increase in Hospitalizations

An aging population and higher incidence of chronic illnesses lead to more hospital admissions requiring IV electrolyte therapy.

Medical Guideline Adoption

Clinical guidelines recommend IV potassium supplementation in cases of severe hypokalemia, supporting consistent demand.

Healthcare Spending and Infrastructure

Rising healthcare expenditure and expanding hospital infrastructure in emerging markets contribute to increased usage.


How does product formulation and packaging impact the market?

Formulation Specifics

The 0.3% potassium chloride in dextrose 5% in a plastic container offers stability, ease of use, and compatibility with existing IV practices. The isotonic nature reduces tissue irritation risk, making it suitable for rapid correction of electrolyte deficits.

Packaging

Plastic containers facilitate single-use applications, reduce contamination, and support hospital sterilization standards. Market players prefer blister packs or sealed bottles with clear labeling for safety and compliance.

Regulatory Standards

U.S. FDA and EMA require compliance with pharmacopeia standards, affecting manufacturing and pricing strategies.


What is the competitive landscape?

Major manufacturers include Baxter International, B. Braun Melsungen AG, Pfizer, and West-Ward Pharmaceuticals. The market is characterized by high entry barriers due to stringent regulatory requirements, patent protections, and the need for sterile manufacturing facilities.

Increased presence of generics and regional players aims to enhance market access, which pressures pricing but expands volume sales.


What are the revenue and profit outlooks?

Revenue Trends

Revenue is projected to grow steadily, with hospitals and clinics accounting for approximately 80% of sales. Price points fluctuate depending on formulation size, regulatory environment, and regional reimbursement policies.

Profit Margins

Gross margins for established manufacturers are around 25-35%, influenced by manufacturing costs, regulatory compliance, and distribution channels.

Investment Outlook

Manufacturers investing in capacity expansion, especially in emerging markets, can expect annual growth rates surpassing industry averages by 1-2 percentage points.


What risks and challenges influence market stability?

Price Pressure

Increased generic competition and regional manufacturing can lead to declining prices.

Regulatory Barriers

Changing standards, such as Good Manufacturing Practices (GMP), and import/export restrictions pose challenges.

Supply Chain Disruptions

Dependence on raw materials and specialized sterile production facilities increases vulnerability to geopolitical or logistic issues.


What is the strategic outlook?

Investors and manufacturers should monitor regional health policies, reimbursement developments, and technological advances such as pre-filled syringes or novel stability formulations that may disrupt existing supply chains.

Expansion into emerging markets presents growth opportunities but requires navigating varying regulatory pathways and infrastructure constraints.


Key Takeaways

  • The global market for IV potassium chloride solutions is growing at approximately 4.2% CAGR (2022–2028).
  • Demand driven by electrolyte imbalance treatment, an aging population, hospitalizations, and clinical guidelines.
  • The product’s packaging in plastic containers supports safety, compliance, and ease of use, influencing market uptake.
  • The competitive landscape features large multinational firms with high barriers to entry; generics are increasing market share.
  • Revenue prospects are positive, with profit margins affected by manufacturing costs and regulatory compliance.
  • Risks include pricing pressures, regulatory changes, and supply chain vulnerabilities.
  • Investment in capacity expansion, especially in emerging regions, offers potential upside.

FAQs

1. How does regional regulation impact the market?
Regulatory standards vary globally, affecting approval times and manufacturing costs. Regions like North America enforce strict GMP standards, increasing compliance expenses but ensuring product safety.

2. What is the typical pricing range for a plastic container of this formulation?
Prices vary based on volume, region, and supplier, generally ranging from $5 to $15 per 100 mL unit in hospitals.

3. How significant is the role of generics in this market?
Generics occupy over 70% of volume sales in mature markets, exerting downward pressure on prices but allowing higher sales volumes.

4. What innovations could influence future demand?
Developments such as pre-filled syringes, stability-enhanced formulations, or smarter IV delivery systems can improve safety and efficiency, impacting demand.

5. How is the COVID-19 pandemic affecting this market?
Pandemic-related disruptions caused supply chain delays and increased demand for hospital IV solutions, but normalization is under way. Healthcare prioritization may temporarily influence procurement patterns.


Sources
[1] MarketsandMarkets, "Intravenous Solutions Market," 2022.
[2] Grand View Research, "Electrolyte Imbalance Treatment Market," 2022.
[3] U.S. FDA, "Guidelines for Injectable Drugs," 2022.
[4] IQVIA, "Global Pharmaceutical Market Data," 2022.

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