Dextrose; sodium chloride - Generic Drug Details

What are the generic drug sources for dextrose; sodium chloride and what is the scope of freedom to operate?

Dextrose; sodium chloride is the generic ingredient in twenty-five branded drugs marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Abbott, Miles, and Otsuka Icu Medcl, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

Five suppliers are listed for this compound.

Summary for dextrose; sodium chloride

US Patents:	0
Tradenames:	25
Applicants:	7
NDAs:	32
Finished Product Suppliers / Packagers:	5
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	6
DailyMed Link:	dextrose; sodium chloride at DailyMed

Pharmacology for dextrose; sodium chloride

Drug Class	Osmotic Laxative
Mechanism of Action	Osmotic Activity
Physiological Effect	Increased Large Intestinal Motility Inhibition Large Intestine Fluid/Electrolyte Absorption

Anatomical Therapeutic Chemical (ATC) Classes for dextrose; sodium chloride

A12CA	Sodium
A12C	OTHER MINERAL SUPPLEMENTS
A12	MINERAL SUPPLEMENTS
A	Alimentary tract and metabolism

B05CB	Salt solutions
B05C	IRRIGATING SOLUTIONS
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

B05XA	Electrolyte solutions
B05X	I.V. SOLUTION ADDITIVES
B05	BLOOD SUBSTITUTES AND PERFUSION SOLUTIONS
B	Blood and blood forming organs

US Patents and Regulatory Information for dextrose; sodium chloride

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% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	016678-001	Approved Prior to Jan 1, 1982	AP	RX	No	No
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631-014	Feb 24, 1988		RX	No	No
B Braun	DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631-006	Feb 24, 1988		RX	No	No
Miles	DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	018500-001	Approved Prior to Jan 1, 1982		DISCN	No	No
B Braun	DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	018030-003	Approved Prior to Jan 1, 1982		DISCN	No	No
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	018386-001	Approved Prior to Jan 1, 1982		DISCN	No	No

Market Dynamics and Financial Trajectory for Dextrose and Sodium Chloride

Last updated: July 29, 2025

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Introduction

Dextrose (glucose) and sodium chloride (common salt) are critical components in the pharmaceutical and medical sectors, primarily used for intravenous (IV) therapy, formulation excipients, and electrolyte replenishment. Their widespread application across healthcare settings influences their market dynamics and financial trajectory, shaped by factors such as technological advances, regulatory policies, demographic shifts, and global health trends.

Market Overview and Application Spectrum

Dextrose and sodium chloride are foundational to maintaining fluid-electrolyte balance, providing essential nutrients, and serving as carriers for active pharmaceutical ingredients. The global IV fluids market, estimated at USD 11.4 billion in 2022, incorporates significant volumes of these ingredients. Their use extends across hospitals, clinics, and in home healthcare, with growth driven by aging populations, the rising prevalence of chronic diseases, and advances in IV therapy formulations.

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Market Dynamics

Drivers of Growth

1. Rising Global Burden of Chronic Diseases
   The increasing incidence of diabetes, cancer, and other chronic conditions necessitates IV therapy for electrolyte balance and nutritional support. For example, dehydration from illnesses like gastroenteritis or during surgical procedures necessitates dextrose-sodium chloride solutions, fueling demand.

2. Aging Population and Geriatric Care
   The elderly demographic is more susceptible to electrolyte imbalances and requires frequent IV therapy. The WHO forecasts that by 2050, 16% of the world's population will be 65 or older, augmenting demand for these saline solutions.

3. Hospitalization and Surgical Procedures
   An expanding volume of surgeries worldwide, especially minimally invasive and outpatient procedures, increases the utilization of IV fluids. Enhanced recovery protocols often include dextrose and saline solutions, further stimulating demand.

4. Advancements in Formulation Technologies
   Innovations such as osmolarity customization and stability improvements prolong shelf-life and efficacy, bolstering market adoption.

5. Regional Healthcare Development
   Emerging markets are experiencing rapid healthcare infrastructure growth. Urbanization and increasing healthcare spending in Asia-Pacific and Latin America are expanding the reach of IV therapies.

Challenges and Restraints

• Price Volatility of Raw Materials
  The production of dextrose and sodium chloride depends heavily on agricultural commodities (for dextrose, primarily corn or sugar; for sodium chloride, salt mining or evaporation). Fluctuations in raw material prices, driven by climate change or geopolitical factors, can impact profit margins.

• Regulatory Barriers and Quality Standards
  Stringent pharmaceutical manufacturing regulations, quality assurance protocols, and import-export restrictions influence market entry and expansion.

• Competition and Market Fragmentation
  A myriad of regional manufactures and multinationals compete for market share, often leading to pricing pressures.

Regulatory Environment

Global legislative agencies, such as the FDA (US), EMA (Europe), and other national regulators, impose strict standards for sterile manufacturing and labeling of injectable solutions containing dextrose and sodium chloride. Regulatory shifts towards stricter compliance intensify R&D and manufacturing costs but ensure market sustainability.

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Financial Trajectory and Market Forecast

Historical Financial Trends

The sector has demonstrated steady growth, with compounded annual growth rate (CAGR) estimates around 4-6% from 2017-2022. The escalating healthcare expenditure, particularly in Asia-Pacific and Latin America, supports this trend. Companies like Baxter International, B. Braun, and Hospira dominate the high-quality IV fluids market, generating billions annually.

Projected Market Growth (2023-2030)

Forecasts project the global IV fluids market to reach approximately USD 15.9 billion by 2030, growing at an estimated CAGR of 5.8%. Dextrose and sodium chloride solutions are anticipated to constitute over 60% of this volume, reflecting their fundamental role.

Key factors influencing this growth trajectory include:

• Technological Innovation: Development of customized electrolyte solutions and stable formulations expands clinical applications.

• Emerging Market Penetration: Increasing healthcare access in Africa, Asia-Pacific, and Latin America elevates demand.

• Telemedicine and Home Healthcare: Growth in outpatient IV therapy is expanding market size, although it requires portable and cost-effective solutions.

Revenue and Profitability Projections

Leading manufacturers' revenues are expected to grow in tandem with market expansion, with an average gross margin of 25-35% for IV fluid products. Investment in quality manufacturing and supply chain optimization will be pivotal to maintaining profitability.

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Pricing Trends and Cost Dynamics

Raw material prices and manufacturing costs directly influence product pricing. Market players have adopted strategies such as vertical integration, raw material procurement diversification, and process innovation to mitigate price volatility. Governments and healthcare payers' emphasis on cost containment pressures manufacturers to optimize production efficiencies.

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Competitive Landscape

Major multinational firms hold predominant positions owing to regulatory compliance, large-scale manufacturing capabilities, and distribution networks. Smaller regional players compete primarily on price and local supply reliability. Strategic alliances, joint ventures, and acquisitions are common to expand product portfolios and market penetration.

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Implications for Stakeholders

• Manufacturers: Emphasize innovation, quality assurance, and cost-efficiency to capture expanding markets.

• Investors: Opportunities exist in companies focusing on technology-driven formulations and emerging markets.

• Healthcare Providers: Need to balance cost considerations with safety and efficacy standards, prompting demand for high-quality, affordable solutions.

• Regulatory Bodies: Continued focus on quality standards influences market stability and product acceptance.

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Key Takeaways

• Growth driven by demographic shifts, disease burden, and technological innovation positions dextrose and sodium chloride as integral to future IV therapy markets.

• Regional healthcare development and emerging markets present significant growth opportunities, although raw material price variability remains a concern.

• Regulatory compliance and quality standards are critical to market access, with intensified scrutiny fostering product integrity.

• Market consolidation and innovation will shape competitive dynamics, influencing pricing and profitability.

• Sustainable supply chains and cost management will be decisive in maintaining margins amid price fluctuations and regulatory challenges.

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FAQs

1. What are the primary drivers behind the growth of dextrose and sodium chloride in pharmaceutical markets?
   The surge is mainly driven by increasing healthcare needs due to aging populations, rising chronic diseases, and expanding surgical procedures demanding IV therapy.

2. How do raw material fluctuations impact the market for these solutions?
   Variability in agricultural commodities and salt supply costs can lead to price volatility, influencing manufacturing costs and product pricing strategies.

3. What technological innovations are influencing market growth?
   Advances include customized electrolyte formulations, improved stability and sterilization processes, and portable IV solutions suited for home healthcare.

4. Which regions are expected to see the fastest growth in demand?
   Asia-Pacific and Latin America are positioned for rapid growth owing to healthcare infrastructure expansion and rising middle-class populations.

5. How are regulatory standards affecting market players?
   Strict quality requirements and sterilization protocols elevate manufacturing costs but ensure product safety, fostering market stability and trust.

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References

1. MarketWatch. (2022). IV fluids market size and forecast.
2. World Health Organization. (2022). Global health and aging statistics.
3. Transparency Market Research. (2022). IV Solutions Market – Industry Analysis.
4. US Food and Drug Administration. (2023). Regulatory guidelines for sterile injectable solutions.
5. Grand View Research. (2022). Healthcare Growth and IV Therapy Innovations.