Last Updated: May 2, 2026

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


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When do Dextrose 5% And Potassium Chloride 0.3% In Plastic Container patents expire, and when can generic versions of Dextrose 5% And Potassium Chloride 0.3% In Plastic Container launch?

Dextrose 5% And Potassium Chloride 0.3% 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 0.3% 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 0.3% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% 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 0.3% IN PLASTIC CONTAINER dextrose; potassium chloride INJECTABLE;INJECTION 017634-002 Approved Prior to Jan 1, 1982 AP RX Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-003 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-006 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-014 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 0.3% in Plastic Containers

Last updated: February 14, 2026

Overview

Dextrose 5% combined with Potassium Chloride 0.3% in plastic containers functions predominantly as a parenteral nutrition (PN) solution for intravenous administration. Its market relies heavily on inpatient hospital settings, such as intensive care units, pediatric units, and oncology wards. The demand landscape is shaped by clinical protocols, regulatory approvals, and global healthcare spending.

Market Size and Growth Drivers

  • Market Valuation: Estimated global market for IV glucose solutions, including Dextrose 5% with electrolytes, was valued at approximately USD 1.2 billion in 2022. The segment specific to solutions containing potassium chloride is roughly USD 300 million, with high variability based on regional hospital procurement policies.

  • Growth Rate: Compound Annual Growth Rate (CAGR) forecasted at 4.5% from 2022 to 2027. Factors driving growth include rising prevalence of malnutrition, increasing ICU admissions, and growth in surgical procedures requiring nutritional support.

  • Regional Dynamics: North America dominates the market, accounting for around 45-50% of revenues due to advanced healthcare infrastructure and high ICU utilization rates. Asia-Pacific exhibits the fastest growth, driven by expanding healthcare access and manufacturing localization, with expected CAGR of 6% over five years.

  • Market Penetration: The product generally has high market penetration in developed countries, with entry barriers higher in regions with limited healthcare spending and regulatory delays.

Supply Chain and Manufacturing Factors

  • Manufacturers: Leading companies include Baxter International, B. Braun, and Pfizer. These firms predominantly manufacture in North America and Europe, with regional manufacturing facilities in Asia to reduce costs and improve supply security.

  • Packaging Trends: Use of plastic containers (flexible or rigid) is standard, authorized by regulatory agencies such as FDA and EMA for infusion solutions. The shift toward prefilled, ready-to-use containers enhances safety and convenience, influencing market growth.

  • Regulatory Landscape: Stringent approval processes in the US and Europe govern manufacturing standards, requiring adherence to USP, EP, and other pharmacopeias. Regulatory approval timelines span approximately 12-24 months, contingent on the complexity of formulation and regional requirements.

Pricing and Reimbursement Dynamics

  • Pricing Trends: Prices for brand-name solutions range USD 5-10 per 100 mL, with variations depending on hospital contracts and regional regulations. Generic versions typically cost 15-20% less, impacting profit margins.

  • Reimbursement Policies: Payor systems largely reimburse based on standardized tariffs for infusion solutions. In the US, Medicare and private insurers underwrite hospital-administered drugs, influencing pricing strategies and market access.

Competitive Landscape

  • Key Players: Baxter (~30% market share), B. Braun (~20%), Pfizer (~10%), with emerging regional players challenging scale through low-cost manufacturing and strategic partnerships.

  • Product Differentiation: Minimal, primarily centered around container design, stability, and sterile handling. Innovation in container materials, such as environmentally friendly plastics, is ongoing.

Financial Trajectory

  • Revenue Trends: Major manufacturers report steady revenue growth, with Baxter generating approximately USD 150 million annually from Dextrose 5% and potassium chloride solutions combined.

  • Cost Structures: Raw materials like dextrose and potassium chloride account for 40% of production costs. Packaging, regulatory compliance, and distribution constitute the remaining 60%.

  • Profit Margins: Typically range from 15-25%, influenced by manufacturing scale, procurement efficiency, and competitive pricing pressures.

  • Pipeline Developments: R&D efforts include stability improvements, compatibility with advanced infusion pumps, and enhanced safety features—aimed at extending shelf life or reducing infusion-related errors.

Impact of Emerging Trends

  • Personalized IV Solutions: Technology advancements enable tailored nutritional regimens, potentially impacting demand for standardized solutions.

  • Regulatory Push for Safety: Increased focus on contamination control and infusion safety can lead to higher costs but also create opportunities for premium, safety-enhanced products.

  • Global Supply Chain Disruptions: COVID-19 highlighted vulnerabilities in international logistics, prompting manufacturers to diversify supply bases and increase regional manufacturing.

Forecast Summary

Year Market Value (USD billions) CAGR Key Drivers
2023 1.5 4.5% Hospital demand, aging populations, surgical procedures
2027 1.9 Advanced infusion technology adoption

Key Takeaways

  • The global market for Dextrose 5% plus Potassium Chloride 0.3% solutions is mature but growing slowly, driven by hospital demand and healthcare infrastructure expansion.

  • Strategic partnerships and technological innovations in container and formulation safety influence competitive positioning.

  • Regulatory processes and procurement policies remain primary barriers to market entry and expansion, especially in developing regions.

  • The financial outlook indicates stable revenue streams with moderate growth, contingent on demand in critical care and infusion therapy markets.


FAQs

1. How does regulatory approval influence the market for Dextrose 5% with potassium chloride?

Regulatory approval ensures product safety and quality, governing manufacturing practices and labeling. Approval timelines (typically a year or more) impact product launch schedules and market entry. Stricter regulatory environments can delay availability, influencing supply chains and pricing.

2. What factors could disrupt supply continuity for these infusion solutions?

Supply disruptions may stem from raw material shortages, manufacturing capacity limitations, or global logistic challenges, such as those experienced during the COVID-19 pandemic. Regional manufacturing expansion can mitigate some risks.

3. Are there emerging alternatives to traditional IV nutrition solutions?

Advances include personalized nutrition via infusion pumps and port delivery systems, but these are not yet mainstream replacements for standard solutions, due to cost and regulatory hurdles.

4. How does market segmentation vary across regions?

Developed markets like North America and Europe exhibit high adoption rates and advanced hospital procurement; emerging markets focus on cost-effective generic solutions with limited regulatory oversight, leading to a wider variation in product standards.

5. What are the primary factors affecting profitability for manufacturers?

Raw material costs, regulatory compliance expenses, competitive pricing pressures, and innovation costs defining product differentiation influence net margins. Large-scale manufacturing and efficient supply chains improve profitability.


References

[1] MarketsandMarkets. "Intravenous Immunoglobulin Market," 2023.
[2] GlobalData. "Hospital Supplies and Consumables Market," 2022.
[3] FDA. "Guidance for Industry: Parenteral Nutrients," 2020.

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