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Last Updated: December 22, 2024

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 10% And Sodium Chloride 0.11% In Plastic Container, and what generic alternatives are available?

Dextrose 10% And Sodium Chloride 0.11% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 10% AND SODIUM CHLORIDE 0.11% 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.

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Summary for DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 10% AND SODIUM CHLORIDE 0.11% 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
B Braun DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-011 Feb 24, 1988 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

DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextrose 10% and Sodium Chloride 0.11% in Plastic Containers

Introduction

Dextrose and sodium chloride injections are crucial in medical settings for fluid and electrolyte replenishment, as well as providing calories. The specific formulation of Dextrose 10% and Sodium Chloride 0.11% in plastic containers is widely used in hospitals and clinical settings. Here, we will delve into the market dynamics and financial trajectory of this specific drug formulation.

Market Overview

The market for intravenous solutions, including dextrose and sodium chloride injections, is driven by the increasing demand for fluid and electrolyte replenishment in healthcare settings. This demand is fueled by the rising incidence of hospitalizations, surgical procedures, and the need for parenteral nutrition.

Key Players

Major pharmaceutical companies such as B. Braun Medical Inc., Baxter International Inc., and others dominate the market for intravenous solutions. These companies invest heavily in research and development to improve the formulation, packaging, and safety of their products[1][2][5].

Market Segmentation

The market can be segmented based on the type of solution (e.g., dextrose concentration, sodium chloride concentration), the type of container (e.g., plastic, glass), and the end-user (e.g., hospitals, clinics, home healthcare).

Demand and Supply Dynamics

Demand Factors

  • Increasing Hospitalizations: The rising number of hospital admissions, particularly for surgical procedures and critical care, drives the demand for intravenous solutions.
  • Aging Population: The elderly population is more prone to conditions requiring fluid and electrolyte replenishment, contributing to increased demand.
  • Advancements in Healthcare: Improvements in medical treatments and the expansion of healthcare services also boost the demand for these solutions.

Supply Factors

  • Manufacturing Capacity: The ability of manufacturers to meet the demand is crucial. Companies like B. Braun and Baxter have expanded their manufacturing capacities to address the increasing demand[4].
  • Regulatory Compliance: Adherence to stringent regulatory standards is essential for the supply of these solutions. Manufacturers must ensure their products meet FDA and other regulatory body requirements.
  • Raw Material Availability: The availability of raw materials such as dextrose and sodium chloride can impact supply. Any shortages or price fluctuations can affect the production and pricing of these solutions.

Financial Trajectory

Revenue Growth

The market for intravenous solutions, including Dextrose 10% and Sodium Chloride 0.11%, has seen steady revenue growth. This growth is attributed to the increasing demand and the expanding healthcare sector. According to industry reports, the global intravenous solutions market is expected to continue growing at a significant CAGR over the next few years.

Pricing Strategies

The pricing of these solutions is influenced by several factors, including production costs, regulatory approvals, and market competition. Manufacturers often adopt competitive pricing strategies to maintain market share. For instance, the cost of a 10% Dextrose and 0.11% Sodium Chloride solution in a 1000 mL plastic container can vary based on the manufacturer and the region.

Cost Structure

The cost structure for these solutions includes:

  • Raw Materials: The cost of dextrose, sodium chloride, and other components.
  • Manufacturing: Costs associated with production, including labor, equipment, and facility expenses.
  • Regulatory Compliance: Costs related to obtaining and maintaining regulatory approvals.
  • Marketing and Distribution: Expenses incurred in promoting and distributing the product.

Competitive Landscape

The competitive landscape for intravenous solutions is highly competitive, with several major players vying for market share.

Key Competitors

  • B. Braun Medical Inc.: Known for their EXCEL containers, B. Braun offers a range of intravenous solutions, including Dextrose 10% and Sodium Chloride 0.11% formulations[1][4].
  • Baxter International Inc.: Baxter provides a variety of intravenous solutions, including those with potassium chloride, which are often used in conjunction with dextrose and sodium chloride solutions[2].

Competitive Strategies

Companies employ various strategies to stay competitive, such as:

  • Innovation: Improving the formulation, packaging, and safety features of their products.
  • Expanding Product Lines: Offering a range of concentrations and container sizes to cater to different clinical needs.
  • Strategic Partnerships: Collaborating with healthcare providers and distributors to enhance market reach.

Regulatory Environment

The regulatory environment plays a critical role in the market dynamics of intravenous solutions.

FDA Regulations

The FDA strictly regulates the production and distribution of intravenous solutions. Manufacturers must comply with Good Manufacturing Practices (GMP) and ensure their products meet specific standards for safety, efficacy, and quality[1][3][5].

Safety and Quality Standards

Ensuring the sterility, non-pyrogenicity, and compatibility of the solutions with other medications is paramount. Manufacturers must conduct rigorous testing and adhere to guidelines to prevent adverse reactions such as hyperosmolality, hypoosmolality, and electrolyte imbalances[2][3].

Patient Safety and Clinical Considerations

Clinical Indications

Dextrose 10% and Sodium Chloride 0.11% solutions are indicated for use as a source of water, calories, and electrolytes. They are particularly useful in patients requiring fluid and electrolyte replenishment, such as those undergoing surgery or experiencing severe dehydration[1][3].

Potential Risks

  • Electrolyte Imbalance: Prolonged use can lead to electrolyte deficits, particularly in serum potassium and phosphate[3].
  • Fluid Overload: Overhydration and congested states, including pulmonary edema, can occur depending on the volume and rate of infusion[2][3].

Market Trends and Future Outlook

Technological Advancements

Advancements in packaging technology, such as the use of flexible plastic containers, have improved the safety and convenience of these solutions. Future innovations may include more sophisticated containers and formulations tailored to specific patient needs.

Growing Demand in Emerging Markets

Emerging markets are expected to drive future growth as healthcare infrastructure improves and the demand for intravenous solutions increases.

Sustainability and Environmental Impact

There is a growing focus on sustainability in the healthcare industry. Manufacturers are exploring eco-friendly packaging options and reducing waste in their production processes.

Key Takeaways

  • The market for Dextrose 10% and Sodium Chloride 0.11% in plastic containers is driven by increasing demand for fluid and electrolyte replenishment.
  • Major players like B. Braun and Baxter dominate the market with a focus on innovation and regulatory compliance.
  • The regulatory environment is stringent, with a focus on safety and quality standards.
  • Patient safety considerations include monitoring for electrolyte imbalances and fluid overload.
  • Future growth is expected, driven by technological advancements and growing demand in emerging markets.

FAQs

Q: What are the primary indications for Dextrose 10% and Sodium Chloride 0.11% solutions?

A: These solutions are indicated as a source of water, calories, and electrolytes for patients requiring fluid and electrolyte replenishment.

Q: What are the potential risks associated with the use of Dextrose 10% and Sodium Chloride 0.11% solutions?

A: Potential risks include electrolyte imbalances, fluid overload, and overhydration, which can lead to conditions such as pulmonary edema.

Q: Which companies are major players in the market for intravenous solutions?

A: Major players include B. Braun Medical Inc. and Baxter International Inc.

Q: What regulatory standards must manufacturers comply with?

A: Manufacturers must comply with FDA regulations, including Good Manufacturing Practices (GMP), to ensure the safety, efficacy, and quality of their products.

Q: How is the market for intravenous solutions expected to grow in the future?

A: The market is expected to grow driven by technological advancements, increasing demand in emerging markets, and the expanding healthcare sector.

Sources

  1. DailyMed: Dextrose and Sodium Chloride Injections USP.
  2. Baxter: Potassium Chloride in Dextrose and Sodium Chloride Injection, USP.
  3. Drugs.com: Dextrose Injection 10%: Package Insert / Prescribing Info.
  4. FDA: Dear Valued B. Braun Customer Letter.
  5. DailyMed: DEXTROSE AND SODIUM CHLORIDE injection, solution.

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