DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075% Drug Patent Profile

When do Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.075% patents expire, and when can generic versions of Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.075% launch?

Dextrose 5%, Sodium Chloride 0.45% And Potassium Chloride 0.075% is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.45% 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.

Summary for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%

US Patents:	0
Applicants:	1
NDAs:	1

US Patents and Regulatory Information for DEXTROSE 5%, SODIUM CHLORIDE 0.45% 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
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

Investment Scenario and Fundamentals Analysis for DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075% Solution

Last updated: February 19, 2026

This analysis evaluates the market potential, manufacturing considerations, regulatory environment, competitive landscape, and financial viability of a pharmaceutical infusion solution containing 5% dextrose, 0.45% sodium chloride, and 0.075% potassium chloride.

Market Overview

Industry Size and Growth

• The global infusion therapy market was valued at approximately $34 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of 6% through 2028[1].
• Consumables such as intravenous (IV) fluids account for around 30% of the market, driven by increasing hospitalization rates, chronic disease prevalence, and outpatient therapy expansion.

Key Drivers

• Rising incidences of dehydration, diabetes, and electrolyte imbalances.
• Expanding outpatient and emerging markets.
• Advancements in infusion delivery systems.

Market Segmentation

• Primary users: Hospitals (60%), outpatient clinics (20%), long-term care facilities (15%), others (5%).
• Geographical focus: North America (40%), Europe (25%), Asia-Pacific (30%), rest of the world (5%).

Competitive Landscape

• Major manufacturers: Baxter International, Becton Dickinson, ICU Medical, Fresenius Kabi.
• Product differentiation primarily via manufacturing scale, quality standards, and integrated medical device offerings.

Product Fundamentals

Composition and Intended Use

The formulation serves as a balanced electrolyte and carbohydrate solution used primarily for:

• Hydration management.
• Electrolyte replenishment.
• Nutritional support.

Manufacturing Considerations

• Raw Materials: High-grade dextrose, pharmaceutical-grade sodium chloride, potassium chloride.
• Quality Standards: Must meet USP (United States Pharmacopeia) or EP (European Pharmacopeia) specifications.
• Sterilization: Autoclaving or filtration processes to ensure sterility.
• Shelf Life: Typically 24-36 months, limited by stability of electrolytes and dextrose.

Cost Structure

• Raw materials: 20-30% of unit cost.
• Manufacturing: 15-20% depending on scale.
• Packaging: 10-15%.
• Distribution and logistics: 10-15%.
• Regulatory compliance and quality assurance: 10%.

Regulatory Environment

Approval Pathways

• Approved as sterile injectable or infusion solutions.
• Countries require Good Manufacturing Practice (GMP) compliance.
• US: FDA approval via Abbreviated New Drug Application (ANDA) if generic, or new drug application (NDA) for innovative formulations.
• Europe: EMA marketing authorization.

Intellectual Property

• Composition patents unlikely due to standard formulation.
• Manufacturing process patents may provide competitive edge.

Investment Considerations

Aspect	Details	Risks/Opportunities
Market Potential	Sustained demand driven by healthcare needs	High demand stability, but sensitive to healthcare budget constraints
Manufacturing Scale	Requires significant capital outlay	Economies of scale reduce per-unit cost
Regulatory Hurdles	Time and cost of approval	Fast-track programs may expedite time-to-market in specific regions
Competition	Dominated by few global players	Entry barriers are high due to quality requirements and regulatory standards
Price Point	Competitive bid-driven pricing	Margin compression possible in commoditized segments

Financial Outlook

• Revenue estimates: Based on annual production volume of 10 million units, average selling price of $0.50 per unit, potential revenue of $5 million/year initially.
• Profitability: Gross margins of 30-40% feasible, depending on scale and efficiencies.
• Break-even timeline: 2-3 years, considering regulatory, manufacturing, and market entry costs.

Strategic Risks and Challenges

• Market saturation by established players.
• Fluctuations in raw material costs.
• Regulatory delays impacting time-to-market.
• Price competition in commoditized segments.

Key Takeaways

• The infusion formulation addresses a steady demand for hydration and electrolyte therapy.
• Entry into established markets requires high initial investment and compliance costs.
• Competitive advantage may be achieved through manufacturing efficiency, quality control, or supply chain integration.
• Growth opportunities exist in emerging markets and outpatient settings.
• Financial viability hinges on manufacturing scale and regulatory approval efficiency.

FAQs

1. What are the primary regulatory hurdles for this infusion solution?
   Compliance with GMP standards, approval via FDA or EMA pathways, and meeting pharmacopeia specifications are primary hurdles.

2. How does raw material pricing impact profitability?
   Variations in dextrose and electrolyte prices directly affect margins; securing long-term supply contracts mitigates risk.

3. What is the typical lead time for regulatory approval?
   US FDA approval can take 12-24 months; Europe’s EMA may take similar timelines, influenced by submission quality and review processes.

4. Is there a significant patent protection for such formulations?
   Standard electrolyte solutions generally lack composition patents; process patents may provide some defensibility.

5. What market segments hold the most growth potential?
   Outpatient clinics and emerging markets in Asia-Pacific exhibit fastest growth due to expanding healthcare infrastructure.

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References

[1] Allied Market Research. (2022). Infusion Therapy Market Size, Share & Trends Analysis Report.