DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER Drug Patent Profile

Which patents cover Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 15meq In Plastic Container, and what generic alternatives are available?

Dextrose 5%, Sodium Chloride 0.33% And Potassium Chloride 15meq In Plastic Container is a drug marketed by Baxter Hlthcare and is included in one NDA.

The generic ingredient in DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER 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 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
DailyMed Link:	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER at DailyMed

Pharmacology for DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER

Drug Class	Osmotic Laxative Potassium Salt
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%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ 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
Baxter Hlthcare	DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER	dextrose; potassium chloride; sodium chloride	INJECTABLE;INJECTION	018629-003	Mar 23, 1982	AP	RX	No	No

Market Dynamics and Financial Trajectory for Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection

Introduction

Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection is a sterile, nonpyrogenic solution used for fluid and electrolyte replenishment, as well as a source of calories. This article delves into the market dynamics and financial trajectory of this specific formulation.

Market Overview

The market for intravenous (IV) solutions, including those containing potassium chloride, dextrose, and sodium chloride, is driven by the demand for fluid and electrolyte replenishment in clinical settings. This demand is influenced by factors such as the prevalence of dehydration, surgical procedures, and the need for parenteral nutrition.

Product Indications and Usage

This solution is indicated for patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride. It serves as a source of water, electrolytes, and calories, making it essential in various clinical scenarios[3][5].

Market Segmentation

The market can be segmented based on the concentration of the components:

• Concentration Variants: The solution is available in various concentrations of potassium chloride (e.g., 10 mEq, 20 mEq, 30 mEq, 40 mEq per liter) and sodium chloride (e.g., 0.2%, 0.33%, 0.45%, 0.9%)[3][5].
• End Users: Hospitals, clinics, and other healthcare facilities are the primary end users.
• Geographical Regions: The market spans globally, with different regions having varying demands based on healthcare infrastructure and patient needs.

Competitive Landscape

The competitive landscape for IV solutions is diverse, with several key players:

• B. Braun Medical Inc.: A prominent manufacturer with various formulations of potassium chloride in dextrose and sodium chloride solutions[2].
• Other Manufacturers: Companies like Hospira, Pfizer, and Fresenius Kabi also produce similar IV solutions.

Financial Trajectory

Revenue Streams

The revenue for these solutions is generated through sales to healthcare facilities and distributors. The pricing can vary based on the concentration of the components, the volume of the solution, and the geographical region.

Market Size and Growth

The global IV solutions market is expected to grow due to increasing healthcare needs and advancements in medical technology. For instance, the global IV solutions market was valued at several billion dollars and is projected to grow at a significant CAGR over the next few years.

Cost Structure

The cost structure includes:

• Raw Materials: Costs associated with dextrose, sodium chloride, and potassium chloride.
• Manufacturing: Costs related to production, including labor, equipment, and facility expenses.
• Regulatory Compliance: Costs for meeting regulatory standards and obtaining approvals.
• Marketing and Distribution: Expenses for promoting the product and distributing it to healthcare facilities.

Key Drivers and Barriers

Drivers

• Increasing Demand for Parenteral Nutrition: The growing need for fluid and electrolyte replenishment in clinical settings drives the demand for these solutions.
• Advancements in Medical Technology: Improvements in IV solution formulations and delivery systems enhance their efficacy and safety.
• Regulatory Support: Favorable regulatory environments that support the approval and use of these solutions.

Barriers

• Competition: The presence of multiple manufacturers and formulations can lead to competitive pricing and market saturation.
• Regulatory Hurdles: Strict regulatory requirements can increase the cost and time to market for new formulations.
• Economic Factors: Economic downturns can affect healthcare budgets and reduce demand.

Market Trends

Personalized Medicine

There is a growing trend towards personalized medicine, where IV solutions are tailored to individual patient needs. This could lead to more customized formulations of potassium chloride, dextrose, and sodium chloride.

Sustainability

The use of eco-friendly packaging and sustainable manufacturing practices is becoming more important. Manufacturers are increasingly focusing on reducing the environmental impact of their products.

Product Lifecycle

The product lifecycle of IV solutions like potassium chloride in 5% dextrose and 0.33% sodium chloride involves several stages:

• Introduction: New formulations are introduced to the market, often with significant marketing efforts.
• Growth: As the product gains acceptance, sales increase.
• Maturity: The product becomes established, and sales stabilize.
• Decline: Eventually, the product may face decline due to newer formulations or changes in clinical practices.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of IV solutions. Products must comply with standards set by regulatory bodies such as the FDA and Health Canada. For example, the FDA requires strict testing and approval processes for IV solutions to ensure safety and efficacy[4].

Conclusion

The market for potassium chloride in 5% dextrose and 0.33% sodium chloride injection is driven by clinical demand and influenced by various market and regulatory factors. Understanding these dynamics is crucial for manufacturers and healthcare providers to navigate the market effectively.

Key Takeaways

• Clinical Indications: The solution is used for fluid and electrolyte replenishment and as a source of calories.
• Market Segmentation: The market is segmented based on concentration variants, end users, and geographical regions.
• Competitive Landscape: Multiple manufacturers compete in the market, with B. Braun Medical Inc. being a key player.
• Financial Trajectory: Revenue is generated through sales, with costs including raw materials, manufacturing, regulatory compliance, and marketing.
• Drivers and Barriers: Increasing demand, advancements in technology, and regulatory support drive the market, while competition, regulatory hurdles, and economic factors act as barriers.

FAQs

1. What are the primary indications for Potassium Chloride in 5% Dextrose and 0.33% Sodium Chloride Injection?

   • This solution is indicated for patients requiring parenteral administration of potassium chloride with minimal carbohydrate calories and sodium chloride, serving as a source of water, electrolytes, and calories[3][5].

2. Who are the key players in the market for IV solutions containing potassium chloride, dextrose, and sodium chloride?

   • Key players include B. Braun Medical Inc., Hospira, Pfizer, and Fresenius Kabi[2].

3. What are the main drivers of the market for these IV solutions?

   • The market is driven by increasing demand for parenteral nutrition, advancements in medical technology, and favorable regulatory environments[3].

4. What are the potential barriers to market growth for these solutions?

   • Barriers include competition from multiple manufacturers, strict regulatory requirements, and economic factors affecting healthcare budgets[3].

5. How does the regulatory environment impact the market for these IV solutions?

   • The regulatory environment significantly impacts the market, as products must comply with standards set by bodies like the FDA and Health Canada to ensure safety and efficacy[4].

Sources

1. Drugs.com - Potassium Chloride in Dextrose and Sodium Chloride.
2. Health Canada - Search results summary.
3. RxList - KCL in D5NS (Potassium Chloride in 5% Dextrose and Sodium Chloride Injection).
4. FDA - Potassium Chloride in 5% Dextrose Injection, USP in Plastic.
5. DailyMed - Potassium Chloride, Dextrose Monohydrate and Sodium Chloride Injection.