Last Updated: June 18, 2026

DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K) Drug Patent Profile


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When do Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 15meq (k) patents expire, and when can generic versions of Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 15meq (k) launch?

Dextrose 5%, Sodium Chloride 0.2% And Potassium Chloride 15meq (k) is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K) 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%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)

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%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K) dextrose; potassium chloride; sodium chloride INJECTABLE;INJECTION 018037-004 Approved Prior to Jan 1, 1982 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

Investment Scenario and Fundamentals Analysis for Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15 mEq (K)

Last updated: February 23, 2026

Market Overview

The IV fluid market, driven by emergency care, surgery, and chronic illness management, is expanding. The global demand for infusion therapies is expected to grow at a compound annual growth rate (CAGR) of roughly 6–8% over the next five years, reaching USD 21 billion by 2027 [1].

The specific formulation—Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15 mEq (K)—commonly used for rehydration, electrolyte balance, and calorie replacement, is a standard in hospital settings. It is a generic, low-cost formulation with high volume production and widespread use.

Key Market Drivers

  • Increased hospitalizations and surgeries globally.
  • Growing prevalence of dehydration, electrolyte imbalances, and metabolic disorders.
  • Rising adoption of intravenous therapy in outpatient settings.
  • Healthcare policies promoting generic and cost-effective therapeutics.

Product Fundamentals

Composition and Use

  • Dextrose 5%: Provides energy through glucose, used in hypoglycemia or calorie deficiency.
  • Sodium Chloride 0.2%: Restores sodium levels, prevents hyponatremia.
  • Potassium Chloride 15 mEq: Corrects and maintains potassium balance, critical for cardiac and muscular function.

Manufacturing and Regulatory Status

  • Typically produced under Good Manufacturing Practices (GMP).
  • Approved by regulatory agencies (FDA, EMA, others) as compatible with standard infusion protocols.
  • Marketed as sterile, ready-to-use solutions.

Cost and Pricing

  • Market prices vary by region and supplier but generally remain low—USD 0.50 to USD 2.00 per unit.
  • Margin potential is limited due to high competition and standardized formulation.

Competitive Landscape

Company Market Share Presence Key Notes
Baxter International 35–40% Global Major supplier of IV solutions, broad distribution
B. Braun 25–30% Global Extensive manufacturing capacity, wide portfolio
Pfizer (Hospira) 10–15% Global Focused on hospital supplies
Others 15–20% Regional Numerous regional manufacturers, generic focus

The market remains highly fragmented with dominant players engaging in commoditized product lines. Barriers to entry are moderate, primarily regulatory compliance and manufacturing scale.

Investment Considerations

Market Opportunity

  • The product's broad hospital use offers a stable demand base.
  • Growth is driven by healthcare infrastructure expansion, particularly in emerging markets.
  • Due to the commoditized nature, profitability hinges on manufacturing efficiency and regulatory compliance.

Risks

  • Pricing pressures from generic competition.
  • Supply chain disruptions affecting raw materials or sterile manufacturing.
  • Regulatory changes impacting approval or labeling.

Strategic Opportunities

  • Contract manufacturing for larger firms.
  • Product line extension, such as combination infusions tailored to specific conditions.
  • Entry into emerging markets with growing infrastructure investment.

Financial Outlook

  • Low profit margins typical; profitability relies on high-volume sales and cost control.
  • R&D investments are minimal; emphasis on scale, quality, and compliance.
  • Potential for private label formulations with existing manufacturers.

Conclusion

The valuation of the Dextrose 5%, Sodium Chloride 0.2%, and Potassium Chloride 15 mEq (K) formulation leans toward a stable, low-margin commodity, with growth tied to broader healthcare infrastructure trends. Investment is most relevant for entities with manufacturing scale, supply chain robustness, and regional market penetration capabilities.

Key Takeaways

  • The IV solution market is growing, driven by healthcare needs.
  • The specific formulation is a standard, low-cost commodity with high volume but limited differentiation.
  • Major players dominate, reducing entry barriers but intensifying price competition.
  • Profitability depends on manufacturing efficiency and regional expansion.
  • Risks include pricing pressures and supply chain vulnerabilities.

FAQs

1. What are the main applications of this IV solution?
It is used for rehydration, electrolyte balance correction, and energy supply in hospitalized and outpatient settings.

2. How does the market for this formulation compare regionally?
North America and Europe dominate with mature markets, while Asia-Pacific is experiencing rapid growth due to expanding healthcare infrastructure.

3. What regulatory hurdles exist for entry into this market?
Manufacturers must adhere to GMP standards, obtain necessary approvals (e.g., FDA, EMA), and demonstrate product sterility and stability.

4. How sensitive is the market to pricing changes?
Very sensitive; as a low-margin commodity, pricing pressures from generic competitors can significantly impact profitability.

5. Are there opportunities for product differentiation?
Limited; differentiation is challenging due to the standardized nature, but regional supply chain efficiency or added features such as better stability could provide competitive edges.


References

[1] Market Research Future. (2022). Global infusion therapy market forecast. Retrieved from https://www.marketresearchfuture.com

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