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Last Updated: December 22, 2024

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container, and when can generic versions of Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container launch?

Potassium Chloride 40meq In Sodium Chloride 0.9% In Plastic Container is a drug marketed by Icu Medical Inc and is included in one NDA.

The generic ingredient in POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER is potassium chloride; sodium chloride. There are two hundred and forty drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the potassium chloride; sodium chloride profile page.

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Summary for POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Pharmacology for POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% 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 POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER potassium chloride; sodium chloride INJECTABLE;INJECTION 019686-002 Oct 17, 1988 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Potassium Chloride in 0.9% Sodium Chloride Injection

Introduction

Potassium Chloride in 0.9% Sodium Chloride Injection is a critical medical product used for fluid and electrolyte replenishment, particularly in hospital settings. This solution is available in various concentrations, with the 40 mEq/L formulation being one of the most commonly used. Here, we will delve into the market dynamics and financial trajectory of this specific formulation.

Market Overview

The market for intravenous (IV) solutions, including Potassium Chloride in 0.9% Sodium Chloride Injection, is driven by several key factors:

Demand for IV Solutions

The demand for IV solutions is steadily increasing due to the growing need for fluid and electrolyte replenishment in both acute and chronic care settings. This demand is further fueled by the rising incidence of dehydration, electrolyte imbalances, and other conditions requiring IV therapy[5].

Hospital and Healthcare Sector Growth

The expansion of the healthcare sector, particularly in hospitals and intensive care units, contributes significantly to the demand for IV solutions. Hospitals are the primary consumers of these products, and their increasing numbers and capacities drive market growth.

Regulatory Environment

Regulatory bodies play a crucial role in shaping the market for IV solutions. Strict guidelines and standards ensure the quality and safety of these products, which can influence production costs and market dynamics. For instance, the FDA regulates the manufacturing, storage, and administration of these solutions to prevent adverse effects such as air embolism and hyperkalemia[4].

Product Specifications and Variations

The Potassium Chloride in 0.9% Sodium Chloride Injection comes in different concentrations, with the 40 mEq/L formulation being a key product.

Concentration and Packaging

This solution is available in 1000 mL flexible plastic containers, typically made of PVC/DEHP, with concentrations of 40 mEq/L of potassium chloride in 0.9% sodium chloride. The product is sterile, nonpyrogenic, and contains no antimicrobial agents[2][4].

Storage and Handling

Proper storage and handling are critical to maintain the efficacy and safety of the product. It should be stored at room temperature (15°C-25°C) and protected from excessive heat[4].

Market Segmentation

The market for Potassium Chloride in 0.9% Sodium Chloride Injection can be segmented based on several factors:

Geographical Segmentation

The global market can be divided into regions such as North America, Europe, Asia-Pacific, and others. Each region has its own set of healthcare infrastructure, regulatory frameworks, and market dynamics that influence the demand and supply of IV solutions.

End-User Segmentation

The primary end-users are hospitals, clinics, and other healthcare facilities. Within these settings, the solution is used in various departments, including intensive care units, emergency departments, and surgical wards.

Competitive Landscape

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

Major Manufacturers

Companies like ICU Medical, Baxter International, and others are prominent in the market. These manufacturers compete based on product quality, pricing, and distribution networks[1][3].

Market Share and Revenue

The market share and revenue of these manufacturers can vary based on their product portfolio, market penetration, and strategic partnerships. For instance, ICU Medical offers a range of IV solutions, including Potassium Chloride in 0.9% Sodium Chloride Injection, which contributes to its market share[1].

Financial Trajectory

The financial performance of the market for Potassium Chloride in 0.9% Sodium Chloride Injection can be analyzed through several metrics:

Revenue Growth

The revenue from IV solutions, including this specific formulation, has been steadily increasing due to the growing demand for fluid and electrolyte replenishment. This growth is expected to continue as the healthcare sector expands and the incidence of conditions requiring IV therapy increases.

Cost Structure

The cost structure includes manufacturing costs, raw material costs, regulatory compliance costs, and distribution expenses. The use of flexible plastic containers and the need for strict quality control measures can impact the overall cost of production[2].

Profit Margins

Profit margins for manufacturers can vary based on their efficiency in production, pricing strategies, and market competition. Companies that can maintain high-quality standards while controlling costs are likely to have higher profit margins.

Challenges and Opportunities

The market for Potassium Chloride in 0.9% Sodium Chloride Injection faces several challenges and opportunities:

Challenges

  • Regulatory Compliance: Strict regulatory requirements can increase production costs and complexity.
  • Supply Chain Disruptions: Disruptions in the supply chain can affect the availability of raw materials and finished products.
  • Competition: The competitive nature of the market can lead to pricing pressures and reduced profit margins.

Opportunities

  • Growing Demand: The increasing demand for IV solutions presents a significant opportunity for growth.
  • Innovations in Packaging: Improvements in packaging technology, such as more durable and safe containers, can enhance product safety and convenience.
  • Emerging Markets: Expanding into emerging markets can provide new revenue streams for manufacturers.

Special Populations and Clinical Considerations

The use of Potassium Chloride in 0.9% Sodium Chloride Injection must be carefully managed in special populations:

Pregnancy and Lactation

The use of this solution during pregnancy and lactation should be approached with caution. The effects on the duration of labor, delivery, and the newborn are not fully understood, and periodic evaluation of fluid balance, glucose, and electrolyte concentrations is recommended[4].

Renal Impairment

Patients with severe renal impairment require particular caution due to the risk of sodium retention, fluid overload, and hyperkalemia[4].

Key Takeaways

  • Increasing Demand: The demand for IV solutions, including Potassium Chloride in 0.9% Sodium Chloride Injection, is driven by the growing need for fluid and electrolyte replenishment.
  • Regulatory Compliance: Strict regulatory guidelines are crucial for ensuring the safety and quality of these products.
  • Competitive Market: The market is competitive, with major manufacturers competing on product quality, pricing, and distribution.
  • Financial Growth: The revenue from these solutions is expected to grow as the healthcare sector expands.
  • Special Populations: Careful management is required when administering this solution to special populations such as pregnant women and patients with renal impairment.

FAQs

Q: What is the typical concentration of Potassium Chloride in 0.9% Sodium Chloride Injection? A: The typical concentrations are 20 mEq/L and 40 mEq/L of potassium chloride in 0.9% sodium chloride[2][4].

Q: What are the storage requirements for Potassium Chloride in 0.9% Sodium Chloride Injection? A: The product should be stored at room temperature (15°C-25°C) and protected from excessive heat[4].

Q: Who are the primary end-users of Potassium Chloride in 0.9% Sodium Chloride Injection? A: The primary end-users are hospitals, clinics, and other healthcare facilities[5].

Q: What are the potential risks associated with administering Potassium Chloride in 0.9% Sodium Chloride Injection to patients with renal impairment? A: Patients with severe renal impairment are at risk of sodium retention, fluid overload, and hyperkalemia[4].

Q: Can Potassium Chloride in 0.9% Sodium Chloride Injection be used during pregnancy and lactation? A: The use of this solution during pregnancy and lactation should be approached with caution, and periodic evaluation of fluid balance, glucose, and electrolyte concentrations is recommended[4].

Sources

  1. ICU Medical: Potassium Chloride in 0.9% Sodium Chloride Injection, USP.
  2. DailyMed: Potassium Chloride in Sodium Chloride Injection, USP in Plastic Container.
  3. ICU Medical: Potassium Chloride in 5% Dextrose and 0.9% Sodium Chloride Injection, USP.
  4. Health Canada: Potassium Chloride in 0.9% Sodium Chloride Injection, USP Prescribing Information.
  5. DailyMed: Potassium Chloride in 0.9% Sodium Chloride Injection.

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