DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER Drug Patent Profile

When do Dextrose 5% And Sodium Chloride 0.2% In Plastic Container patents expire, and what generic alternatives are available?

Dextrose 5% And Sodium Chloride 0.2% In Plastic Container is a drug marketed by B Braun, Miles, Abbott, and Icu Medical Inc. and is included in five NDAs.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER is dextrose; 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; sodium chloride profile page.

Summary for DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

US Patents:	0
Applicants:	4
NDAs:	5
Finished Product Suppliers / Packagers:	2
DailyMed Link:	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER at DailyMed

Pharmacology for DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

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

US Patents and Regulatory Information for DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Icu Medical Inc	DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	017606-001	Approved Prior to Jan 1, 1982	AP	RX	Yes	Yes
B Braun	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	018030-004	Approved Prior to Jan 1, 1982		DISCN	No	No
Miles	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	018399-001	Approved Prior to Jan 1, 1982		DISCN	No	No
Abbott	DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019482-001	Oct 4, 1985		DISCN	No	No
B Braun	DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER	dextrose; sodium chloride	INJECTABLE;INJECTION	019631-007	Feb 24, 1988	AP	RX	No	No

Market Dynamics and Financial Trajectory for Dextrose 5% and Sodium Chloride 0.2% Injection in Plastic Containers

Introduction

Dextrose and Sodium Chloride injections are crucial in medical settings for fluid, electrolyte, and caloric replenishment. The specific formulation of 5% Dextrose and 0.2% Sodium Chloride Injection, USP, packaged in plastic containers, is a widely used product. Here, we will delve into the market dynamics and financial trajectory of this drug.

Market Overview

The market for parenteral solutions, including Dextrose and Sodium Chloride injections, is driven by the increasing demand for intravenous fluids in hospitals, clinics, and other healthcare facilities. This demand is fueled by the growing need for fluid and electrolyte replenishment, particularly in surgical, critical care, and emergency settings[3][5].

Product Specifications

• Concentration: 5% Dextrose and 0.2% Sodium Chloride.
• Container Sizes: Available in 250 mL, 500 mL, and 1000 mL flexible plastic containers.
• Container Material: PVC/DEHP.
• Shelf Life: Varies from 18 to 24 months depending on the container size[1][3][5].

Market Demand

The demand for Dextrose and Sodium Chloride injections is consistent due to their essential role in patient care. Factors such as an aging population, increased surgical procedures, and the need for fluid resuscitation in critical care contribute to the steady demand. Additionally, the COVID-19 pandemic has highlighted the importance of having a reliable supply of intravenous fluids, further boosting demand[4].

Supply Chain and Availability

The supply chain for these injections involves several key players, including manufacturers, distributors, and wholesalers. Companies like Baxter and ICU Medical are major suppliers of these products. However, supply chain disruptions, such as manufacturing delays and distribution issues, can impact availability. For instance, the USHP Supply Availability Report highlights periodic shortages and manufacturing delays affecting the supply of these and related products[4].

Pricing and Cost Factors

The pricing of Dextrose and Sodium Chloride injections can vary based on the container size, concentration, and supplier. Generally, these products are priced competitively due to the presence of multiple manufacturers. Costs are influenced by raw material prices, manufacturing processes, and regulatory compliance. Here is a rough estimate of the costs:

• 250 mL: Typically priced around $5-$10 per unit.
• 500 mL: Priced around $10-$20 per unit.
• 1000 mL: Priced around $20-$30 per unit[1][4].

Financial Trajectory

The financial performance of companies producing Dextrose and Sodium Chloride injections is generally stable due to the consistent demand. Here are some key financial indicators:

Revenue

• The revenue from these products is steady, driven by the continuous need for intravenous fluids in healthcare settings.
• Companies like Baxter and ICU Medical report significant revenues from their parenteral solutions segment, which includes Dextrose and Sodium Chloride injections.

Profit Margins

• Profit margins can vary based on production costs, market competition, and pricing strategies.
• Companies often maintain moderate profit margins due to the competitive nature of the market and the need to keep prices affordable for healthcare providers.

Market Growth

• The market for parenteral solutions is expected to grow due to increasing healthcare needs and advancements in medical treatments.
• According to industry reports, the global parenteral nutrition market is projected to grow at a CAGR of around 5-7% over the next few years.

Competitive Landscape

The market for Dextrose and Sodium Chloride injections is competitive, with several key players:

• Baxter International Inc.
• ICU Medical, Inc.
• B. Braun Medical Inc.
• Hospira, Inc. (now part of Pfizer)

These companies compete on factors such as product quality, pricing, and supply chain reliability[1][3][4].

Regulatory Environment

The production and distribution of Dextrose and Sodium Chloride injections are heavily regulated by health authorities such as the FDA. Compliance with Good Manufacturing Practices (GMP) and other regulatory standards is crucial. Any non-compliance can lead to product recalls, fines, and damage to the company's reputation[5].

Innovation and R&D

While the formulation of Dextrose and Sodium Chloride injections is well-established, innovation in packaging and delivery systems continues. For example, advancements in flexible plastic containers and the development of more stable formulations are areas of ongoing research and development[2].

Supply Chain Risks

Supply chain risks, including raw material shortages, manufacturing disruptions, and distribution delays, can significantly impact the availability and pricing of these products. Companies must mitigate these risks through robust supply chain management and contingency planning[4].

Market Trends

Increasing Use in Critical Care

• The use of Dextrose and Sodium Chloride injections in critical care settings is on the rise, driven by the need for rapid fluid and electrolyte replenishment.

Growing Demand in Emerging Markets

• Emerging markets are experiencing increased demand for intravenous fluids due to improving healthcare infrastructure and growing healthcare needs.

Sustainability Initiatives

• There is a growing focus on sustainability in packaging, with companies exploring more environmentally friendly options for their products.

Key Takeaways

• Stable Demand: The demand for Dextrose and Sodium Chloride injections remains consistent due to their essential role in healthcare.
• Competitive Market: The market is competitive, with multiple players competing on quality, pricing, and supply chain reliability.
• Regulatory Compliance: Strict regulatory compliance is necessary to ensure product safety and quality.
• Innovation: Ongoing innovation in packaging and formulations is expected to continue.
• Supply Chain Risks: Companies must manage supply chain risks to maintain product availability and pricing stability.

FAQs

Q: What are the common container sizes for Dextrose and Sodium Chloride injections?

A: These injections are available in 250 mL, 500 mL, and 1000 mL flexible plastic containers.

Q: What is the shelf life of Dextrose and Sodium Chloride injections?

A: The shelf life varies from 18 to 24 months depending on the container size.

Q: Who are the major suppliers of Dextrose and Sodium Chloride injections?

A: Major suppliers include Baxter International Inc., ICU Medical, Inc., and B. Braun Medical Inc.

Q: What factors influence the pricing of Dextrose and Sodium Chloride injections?

A: Pricing is influenced by raw material costs, manufacturing processes, and regulatory compliance.

Q: What are the potential risks in the supply chain for these products?

A: Risks include raw material shortages, manufacturing disruptions, and distribution delays.

Sources

1. ICU Medical: 5% Dextrose and 0.225% Sodium Chloride Injection, USP.
2. Oxford Journals: Stability of milrinone in 0.45 % sodium chloride and 5% dextrose injections.
3. DailyMed: DEXTROSE AND SODIUM CHLORIDE injection, solution.
4. Baxter: USHP Supply Availability Report - April 2nd, 2024.
5. DailyMed: 5% Dextrose and 0.225% Sodium Chloride Injection, USP.