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 Icu Medical Inc, and is included in thirty-two NDAs. Additional information is available in the individual branded drug profile pages.

Four suppliers are listed for this compound.

Summary for dextrose; sodium chloride

US Patents:	0
Tradenames:	25
Applicants:	7
NDAs:	32
Finished Product Suppliers / Packagers:	4
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 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	016697-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
B Braun	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631-004	Feb 24, 1988	AP	RX	No	No
B Braun	DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631-013	Feb 24, 1988		RX	No	No
B Braun	DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631-016	Jan 19, 1990		RX	No	No
B Braun	DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	018030-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Fresenius Kabi Usa	DEXTROSE 5% AND SODIUM CHLORIDE 0.9%	dextrose; sodium chloride	INJECTABLE;INJECTION	211211-001	Sep 14, 2020	AP	RX	No	No

Dextrose; sodium chloride Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextrose and Sodium Chloride Solutions

Introduction

Dextrose and sodium chloride solutions are widely used in medical settings for various purposes, including the treatment of dehydration, hypoglycemia, and as a source of electrolytes and calories. Here, we will delve into the market dynamics and financial trajectory of these solutions.

Market Size and Growth

The global market for dextrose injections, which often include sodium chloride, is substantial and growing. As of 2020, the global dextrose injection market was valued at US$ 9,512.7 million and is expected to exhibit a Compound Annual Growth Rate (CAGR) of 5.7% from 2020 to 2027[1].

Driving Factors

Several factors are driving the growth of this market:

Increasing Incidence of Diabetes and Associated Conditions

The rising incidence of diabetes and related conditions such as hypoglycemia is a significant driver. According to the World Health Organization, the number of people with diabetes globally increased from 108 million in 1980 to 422 million in 2014[1].

Launch and Approval of New Products

Key players in the market are focusing on launching new products and obtaining approvals to expand their product portfolios. For instance, the approval of Clindamycin in dextrose injection (D5W) by the U.S. Food and Drug Administration in 2017 is a notable example[1].

Growing Awareness of Hydration

Increased awareness of the importance of hydration, particularly in medical settings, is also driving the demand for dextrose saline solutions. This is evident in the expanding market in India, driven by the growth of hospitals and clinics and the rising prevalence of diabetes[3].

Market Segmentation

The market for dextrose and sodium chloride solutions can be segmented based on several factors:

By Type

• Dextrose and Sodium Chloride Injection: Solutions with varying concentrations of dextrose and sodium chloride, such as 5% Dextrose and 0.45% Sodium Chloride Injection, are widely used[5].

By Application

• Medical Settings: These solutions are used in hospitals, clinics, and other healthcare facilities to treat dehydration, hypoglycemia, and to provide electrolytes and calories.
• Food and Beverage: Dextrose, in its anhydrous form, is also used in the food and beverage industry due to its long shelf life and sweet taste[4].

By Region

• Global Market: The market is expanding globally, with significant growth expected in regions like Asia Pacific Excluding Japan (APEJ), particularly in India and China[3][4].

Techno-Economic Viability

The production of dextrose saline solutions involves several steps and requires adherence to strict regulatory standards:

Manufacturing Process

• The process includes preparing saline and dextrose solutions, followed by sterilization through filtration or autoclaving[3].

Regulatory Compliance

• Manufacturers must comply with Good Manufacturing Practices (GMP) and obtain necessary licenses and clearances from regulatory bodies like the Drug Controller General of India (DCGI)[3].

Capital Investment

• The capital expenditure for setting up a dextrose saline manufacturing facility varies based on production capacity, infrastructure needs, and equipment costs[3].

Financial Trajectory

The financial trajectory of the dextrose and sodium chloride solutions market is promising:

Revenue Growth

• With a projected CAGR of 5.7% from 2020 to 2027, the market is expected to see significant revenue growth[1].

Profitability

• The techno-economic viability study indicates that the market demand for dextrose saline, driven by increasing diabetes prevalence and hydration awareness, contributes to its profitability[3].

Price Dynamics

• Recent data shows that prices for dextrose and sodium chloride solutions can fluctuate due to factors such as testing and validation processes and updates in test methods related to expiration dating. For example, B. Braun Medical Inc. has reported price increases for various dextrose and sodium chloride injection solutions in 2024[2].

Impact of COVID-19

The COVID-19 pandemic has had a mixed impact on the market:

Increased Demand

• The pandemic has led to an increased demand for intravenous fluids and nutrient replenishers, including dextrose and sodium chloride solutions, due to the need for intensive care and hydration in COVID-19 patients[1].

Supply Chain Disruptions

• However, the pandemic has also caused supply chain disruptions, affecting the production and distribution of these solutions[1].

Key Players

Several key players are active in the market:

B. Braun Medical Inc.

• Known for their extensive range of dextrose and sodium chloride injection solutions, including 0.30% KCL in 5% Dextrose and 0.45% NaCl Injection USP[2].

Baxter International Inc.

• Offers a variety of dextrose and sodium chloride injection solutions, such as the Dextrose and Sodium Chloride Injection USP in VIAFLEX Plastic Containers[5].

Other Players

• Companies like Cargill, Fisher Scientific, and Rouqette are also significant players in the broader dextrose market, including anhydrous dextrose used in various applications[4].

Risks and Side Effects

While dextrose and sodium chloride solutions are crucial in medical care, they come with potential risks:

Hyperosmolality and Hypoosmolality

• Intravenous administration can lead to hyperosmolality, osmotic diuresis, and dehydration, or hypoosmolality, depending on the solution concentration and patient condition[5].

Electrolyte Disturbances

• These solutions can cause electrolyte disturbances such as hyponatremia, hypokalemia, hypophosphatemia, and hypomagnesemia[5].

Key Takeaways

• The global market for dextrose and sodium chloride solutions is growing, driven by increasing diabetes prevalence and hydration awareness.
• The market is expected to exhibit a CAGR of 5.7% from 2020 to 2027.
• Key players are focusing on new product launches and regulatory compliance.
• The COVID-19 pandemic has increased demand but also caused supply chain disruptions.
• The solutions come with potential risks such as hyperosmolality, hypoosmolality, and electrolyte disturbances.

FAQs

1. What is the projected growth rate of the dextrose injection market?

   • The dextrose injection market is expected to exhibit a CAGR of 5.7% from 2020 to 2027[1].

2. What are the primary drivers of the dextrose and sodium chloride solutions market?

   • The primary drivers include the increasing incidence of diabetes and associated conditions, new product launches, and growing awareness of hydration[1][3].

3. Which regions are expected to see significant growth in the dextrose and sodium chloride solutions market?

   • Regions such as Asia Pacific Excluding Japan (APEJ), particularly India and China, are expected to see significant growth[3][4].

4. What are the potential risks associated with dextrose and sodium chloride solutions?

   • Potential risks include hyperosmolality, hypoosmolality, electrolyte disturbances, and overhydration/hypervolemia[5].

5. How has the COVID-19 pandemic impacted the dextrose and sodium chloride solutions market?

   • The pandemic has increased demand for these solutions but also caused supply chain disruptions[1].

Sources

1. Coherent Market Insights - Dextrose Injection Market Size and Trends
2. New York State Department of Financial Services - Drug Price Increases Report - October 2024
3. Entrepreneur India - Feasibility and Techno Economic Viability Study on Dextrose Saline Manufacturing
4. Persistence Market Research - Dextrose Anhydrous Market: Global Industry Analysis and Forecast
5. Baxter - Dextrose and Sodium Chloride Injection, USP - Baxter