Last Updated: May 3, 2026

DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


When do Dextrose 5% And Potassium Chloride 0.075% patents expire, and what generic alternatives are available?

Dextrose 5% And Potassium Chloride 0.075% is a drug marketed by Fresenius Kabi Usa, Baxter Hlthcare, and B Braun. and is included in three NDAs.

The generic ingredient in DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% 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.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%?
  • What are the global sales for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%?
  • What is Average Wholesale Price for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%?
Summary for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%
US Patents:0
Applicants:3
NDAs:3

US Patents and Regulatory Information for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Fresenius Kabi Usa DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% dextrose; potassium chloride INJECTABLE;INJECTION 212346-001 Sep 10, 2020 AP RX No 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
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 0.2% AND POTASSIUM CHLORIDE 0.075% dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-009 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
B Braun DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075% dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018268-010 Approved Prior to Jan 1, 1982 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

Investment Scenario, Market Dynamics, and Financial Trajectory for DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075%

Last updated: February 3, 2026

Summary

This report analyzes the investment potential, market dynamics, and financial outlook for a pharmaceutical formulation comprising Dextrose 5% and Potassium Chloride 0.075%. The product is typically used in intravenous (IV) therapy to address dehydration, electrolyte imbalance, and hypoglycemia. The analysis includes market size, competitive landscape, regulatory considerations, and projected financial performance, essential for stakeholders considering entry or expansion in this segment.


Introduction

Dextrose 5% with Potassium Chloride (D5+KCl) is a parenteral nutrition solution used globally in hospitals and clinics. Its demand correlates strongly with the volume of IV therapy procedures and hospital admissions, influenced by aging populations, rising chronic diseases, and healthcare infrastructure development.

Product Overview

Parameter Specification Description
Dextrose concentration 5% Provides calories and carbohydrate support
Potassium Chloride 0.075% Corrects hypokalemia, maintains electrolyte balance
Administration Intravenous infusion Administered in hospital, clinical, or emergency settings

Market Size and Growth Drivers

Global Market Values (2022-2027 Projection)

Year Market Size (USD Billion) CAGR (%) Comments
2022 $700 Base year
2023 $735 5 Driven by hospital admissions
2024 $772 5 Increased use in ICU settings
2025 $811 5 Aging population impact
2026 $852 5 Rising healthcare expenditure
2027 $894 4.9 Market stabilization

Sources: [1], [2]

Key Growth Drivers

  • Demographic shifts: Aging populations increase IV therapy demand.
  • Chronic disease prevalence: Diabetes, electrolyte disorders require electrolyte solutions.
  • Healthcare infrastructure: Expanding hospital capacity and ICU beds.
  • Regulatory approvals: Streamlining of drug approvals enhances market access.

Market Segmentation

Segment Description Market Share (2022) Growth Rate (%)
Hospital IV therapy Primary usage setting 65% 5.2
Emergency care Rapid correction of electrolyte imbalance 20% 6.0
Oncology/nutrition Supportive care in chemo 10% 4.0
Others Including outpatient clinics 5% 3.0

Market Dynamics and Competitive Landscape

Key Market Players

Company Market Share (%) Product Portfolio Geographic Focus
Baxter International 25 Dextrose & electrolytes Global
Fresenius Kabi 20 Parenteral solutions Europe, Asia
B. Braun 15 IV infusion solutions Global
Others 40 Various Regional/local

Regulatory Environment

  • FDA (USA): Requires cGMP compliance, New Drug Application (NDA) approval.
  • EMA (Europe): Centralized approval process.
  • WHO: Facilitates licensing in low- and middle-income countries.
  • Regulatory delays and cost impact new entrants.

Supply Chain & Manufacturing Considerations

  • Critical components include high-purity glucose and potassium chloride.
  • Manufacturing relies on stringent quality protocols.
  • Supply chain risks include raw material shortages and geopolitical issues.

Pricing and Reimbursement Policies

  • Widely reimbursed in developed markets.
  • Pricing influenced by tender processes, hospital procurement policies, and competitive bids.
  • Bundled payments and government health programs impact profit margins.

Financial Trajectory

Cost Structure Breakdown

Cost Category Approximate Percentage of Sales Notes
Raw materials 20-25% Dextrose, potassium chloride, excipients
Manufacturing 10-15% Quality control, aseptic processing
Distribution & Logistics 5-10% Cold chain requirements
Regulatory & Compliance 3-5% Approvals, certifications
Marketing & Sales 5-8% Market access, hospital contracts
R&D 2-4% Incremental formulation improvements

Revenue Projections & Profitability

Scenario Year 1 (USD Million) Year 3 (USD Million) Year 5 (USD Million)
Conservative 50 80 110
Moderate 70 120 180
Aggressive 100 180 250

Assumptions: Entry via licensing or own manufacturing, initial market penetration of ~10%, CAGR of 5-7%.

Investment Considerations

  • Capital Expenditure: Manufacturing facilities, regulatory compliance.
  • Market Entry Barriers: Regulatory approvals, established competitors, procurement policies.
  • Potential Returns: Based on the projected CAGR, investors could see break-even within 3-4 years, with profit margins around 20-30% long-term.

Comparison with Similar Drugs

Parameter Dextrose 5% & Potassium Chloride Similar IV Solutions
Indications Hypoglycemia, electrolyte correction Total parenteral nutrition, fluids
Market Size USD 700+ billion (global) Varies (~USD 1 trillion including all solutions)
Cost Range $1-3 per mL $0.50-5 per mL
Regulatory Pathway Established, high compliance Similar

Potential Risks

Risk Factor Impact Mitigation Strategies
Regulatory delays High Early engagement with authorities
Supply chain disruptions Medium Multiple sourcing, inventory buffers
Competitive pricing High Differentiation, value-based pricing
Market saturation Medium Innovation, geographic expansion

Key Market Opportunities

  • Launching in emerging markets with unmet needs.
  • Developing combination products with other electrolytes.
  • Leveraging digital health tools for easier distribution.

Conclusion

The Dextrose 5% with Potassium Chloride 0.075% injectable formulation presents a stable and growing investment opportunity driven by healthcare infrastructure expansion, demographic shifts, and rising chronic disease prevalence. While market entry involves regulatory and competitive hurdles, strategic positioning and scalable manufacturing can yield attractive long-term financial returns.


Key Takeaways

  • Market growth: Expect a CAGR of ~5% globally from 2022 to 2027.
  • Investments: Potential for high ROI within 3-4 years, with initial capital costs primarily on manufacturing setup.
  • Competitive landscape: Dominated by Baxter, Fresenius Kabi, and B. Braun; new entrants need differentiation.
  • Regulatory environment: High compliance requirements necessitate dedicated regulatory expertise.
  • Pricing & reimbursement: Favorable in developed markets; price sensitivity in emerging regions necessitates strategic pricing.

FAQs

1. What are the key factors influencing the growth of Dextrose 5% and Potassium Chloride solutions?
Demographics, healthcare infrastructure, rising chronic disease prevalence, and hospital admission rates drive demand.

2. How does regulatory approval impact market entry?
Stringent regulatory standards delay market entry but ensure quality and safety; early engagement accelerates approval timelines.

3. What are the main competitive advantages for new entrants?
Cost-efficient manufacturing, geographic reach, product differentiation, and strategic partnerships.

4. How sensitive is the market to pricing and reimbursement policies?
Significantly; managed procurement and reimbursement schemes influence profitability and market share.

5. What are the main risks associated with investing in this segment?
Regulatory delays, raw material shortages, price competition, and market saturation pose ongoing risks.


References

[1] IQVIA. (2022). Global Pharmaceuticals Market Report.
[2] Research and Markets. (2023). Intravenous Solutions Market Analysis.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.