Last Updated: May 2, 2026

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 5% And Potassium Chloride 0.075% In Plastic Container, and what generic alternatives are available?

Dextrose 5% And Potassium Chloride 0.075% In Plastic Container is a drug marketed by Baxter Hlthcare and B Braun and is included in two NDAs.

The generic ingredient in DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER is dextrose; potassium chloride; sodium 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; sodium chloride profile page.

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Summary for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 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
Baxter Hlthcare DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 017634-004 Approved Prior to Jan 1, 1982 AP RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-011 Jan 18, 1986 DISCN 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 Dextrose 5% and Potassium Chloride 0.075% in Plastic Containers

Last updated: January 25, 2026

Executive Summary

The combination of Dextrose 5% and Potassium Chloride 0.075% in plastic containers addresses critical needs in medical rehydration and electrolyte management. The global market for intravenous (IV) fluids, particularly hypertonic solutions, is projected to grow substantially driven by rising healthcare demands, aging populations, and increasing incidences of chronic diseases. This report analyzes the market's current state, key drivers, competitive landscape, regulatory considerations, and forecasting trends relevant to this specific pharmaceutical formulation.


1. Market Overview: Dextrose 5% and Potassium Chloride in Plastic Containers

1.1 Product Profile

  • Formulation: Dextrose 5% (a 5% glucose solution) combined with 0.075% potassium chloride.
  • Delivery Container: Prefilled, sterile plastic IV bags/containers.
  • Application: Fluid and electrolyte replenishment, hypoglycemia management, and in surgical or critical care settings.

1.2 Clinical Indications

Indication Description
Rehydration Restoring fluid balance in dehydration cases.
Electrolyte Balance Correcting hypokalemia.
Hyperglycemia Management Maintaining glycemic control in IV therapy.
Surgical and Critical Care Maintaining electrolyte homeostasis during procedures.

2. Market Drivers

2.1 Rising Global Healthcare Expenditure

Global healthcare spending is escalating at a CAGR of approximately 5.4% (2018-2028), spurring increased procurement of IV fluids.

2.2 Demographic Shifts

  • Aging Population: The world's population over 60 is projected to reach 2.1 billion by 2050 [2], increasing the demand for electrolyte management and supportive therapies.
  • Chronic Diseases: Higher incidence of diabetes, renal disease, and gastrointestinal disorders enhances the need for IV solutions.

2.3 Expansion in Critical Care Settings

Intensive care unit (ICU) admissions are increasing globally, especially in emergent regions, elevating the demand for electrolyte-balanced IV fluids.

2.4 Regulatory & Policy Environment

  • Stringent regulations for sterile, ready-to-use IV solutions bolster demand for prefilled plastic containers.
  • Governments and health agencies promote standardized, portable, and safe formulations.

3. Market Segmentation

Segment Description Estimated Market Share (2022)
End-users Hospitals, clinics, ambulatory surgical centers 65%
Geography North America, Europe, Asia-Pacific, Latin America, MEA North America (35%), APAC (30%) dominant
Container Type Plastic (PVC, non-PVC) 90% in use

4. Competitive Landscape & Key Players

Company Market Share (Estimated, 2022) Notable Products Strategic Initiatives
Baxter International 35% Dextrosol & Potassium chloride solutions Expansion of prefilled bag offerings
B. Braun 20% Preservative-free IV fluids Improving manufacturing capacity
Fresenius Kabi 15% Critical care solutions Emphasizing regional manufacturing hubs
Other Players 30% Various generics Focused on affordability & distribution

4.1 Innovation & Differentiation

  • Use of non-PVC, ethylene vinyl acetate (EVA) containers to reduce leaching risk.
  • Incorporation of smart packaging with traceability features.
  • Efforts to improve shelf life and compatibility with infusion devices.

5. Regulatory & Policy Considerations

5.1 Approval Pathways

  • FDA (U.S.): 510(k) or NDA pathways.
  • EMA (Europe): Centralized approval via MAA.
  • Country-specific: Stringent Good Manufacturing Practices (GMP), sterile processing, and labeling.

5.2 Quality & Safety Standards

  • Must comply with ISO 13485, USP, and other international standards.
  • Focus on biocompatibility testing and leachables/extractables testing.

5.3 Reimbursement & Pricing

  • Typically reimbursed under hospital pharmacy budgets.
  • Pricing strategies influenced by raw material costs, manufacturing efficiency, and regional healthcare policies.

6. Market Forecast & Financial Trajectory

6.1 Market Size & Growth Projections (2023-2030)

Year Market Size (USD billion) CAGR Notes
2022 2.8 Baseline
2023 3.0 6.4% Onset of post-pandemic recovery
2025 3.8 7.0% Increased ICU utilization
2030 5.5 8.1% Accelerated adoption and new product launches

6.2 Regional Growth Dynamics

Region 2022 Market Share CAGR (2023-2030) Drivers
North America 35% 6.5% Healthcare infrastructure, regulatory rigor
Europe 20% 6.7% Aging demographics, hospital modernization
Asia-Pacific 30% 9.2% Growing healthcare access, emerging markets
Latin America & MEA 15% 7.5% Increasing healthcare expenditure

6.3 Revenue Breakdown by Container & Formulation

Container Type Market Share Primary Material Reusability Impact on Market
Plastic PVC 70% PVC Single-use Cost-effective, widely used
Non-PVC (EVA, TPU) 20% Various Reusable/Leak-resistant Growing due to safety standards
Others 10% - - Smaller niche segments

7. Comparison with Similar Formulations

Attribute Dextrose 5% + KCl 0.075% Normal Saline (0.9%) Lactated Ringer's Hypertonic Saline
Primary Use Glucose + Electrolyte Hydrotonic fluid Electrolyte replenishment Sodium chloride solutions
Container Plastic (PVC/non-PVC) Plastic Plastic Plastic
Price Range USD 2-5 per 100mL USD 1-3 per 100mL USD 2-4 per 100mL USD 4-8 per 100mL
Growth Drivers Diabetes management, critical care General hydration Surgical recovery Emergency care

8. Potential Challenges & Risks

Challenge Impact Mitigation Strategies
Raw Material Volatility Cost fluctuations Long-term supplier contracts
Regulatory Delays Market entry delays Early engagement with regulators
Competition from Generics Price erosion Product differentiation, branding
Supply Chain Disruptions Distribution delays Diversified manufacturing base

Key Takeaways

  • The market for Dextrose 5% and Potassium Chloride 0.075% in plastic containers is positioned for steady growth driven by increasing healthcare needs and modernized hospital infrastructure.
  • Asia-Pacific outpaces other regions with a projected CAGR over 9%, primarily due to emerging markets with expanding healthcare systems.
  • The shift towards non-PVC, safety-enhanced containers presents opportunities for innovation and differentiation.
  • Regulatory compliance remains critical; early engagement with authorities facilitates smoother market entry.
  • Competitive advantage hinges on cost management, product safety, and accessibility, particularly in price-sensitive markets.

9. FAQs

Q1: What factors influence the pricing of Dextrose 5% + KCl solutions?
Pricing depends on raw material costs, manufacturing scale, container material, regulatory compliance expenses, and regional healthcare reimbursement policies.

Q2: How does the shift to non-PVC containers impact market dynamics?
It prompts manufacturers to invest in alternative materials, increasing production costs but potentially offering safety and compatibility advantages, thereby influencing pricing and adoption rates.

Q3: What regulatory hurdles are specific to electrolyte solutions in plastic containers?
Approval requires demonstration of sterility, stability, biocompatibility, and absence of leachables, alongside adherence to GMP and sterile processing standards.

Q4: Which regions are emerging markets for this formulation?
Asia-Pacific and Latin America exhibit rapid growth potential due to expanding healthcare infrastructure and increasing demand for IV solutions.

Q5: What are the key innovations driving market expansion?
Smart packaging, non-PVC materials, improved shelf-life, and customized delivery devices enhance safety, efficacy, and market appeal.


References

  1. Market Data Forecast, “Intravenous (IV) Solutions Market Analysis,” 2022.
  2. United Nations, “World Population Ageing 2050,” 2019.
  3. Global Industry Analysts, “Medical Packaging: Market Trends and Forecasts,” 2021.
  4. FDA, “Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing,” 2019.
  5. IQVIA, “Global Pharmaceutics Report,” 2022.

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