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Last Updated: December 22, 2024

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 5% And Sodium Chloride 0.45% In Plastic Container patents expire, and what generic alternatives are available?

Dextrose 5% And Sodium Chloride 0.45% In Plastic Container is a drug marketed by Abbott, B Braun, Icu Medical Inc, and Miles. and is included in five NDAs.

The generic ingredient in DEXTROSE 5% AND SODIUM CHLORIDE 0.45% 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 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 5% AND SODIUM CHLORIDE 0.45% 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
Abbott DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019484-001 Oct 4, 1985 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 017607-001 Approved Prior to Jan 1, 1982 AP RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018030-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-009 Feb 24, 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

DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for 5% Dextrose and 0.45% Sodium Chloride Injection

Introduction

The 5% Dextrose and 0.45% Sodium Chloride Injection is a widely used intravenous solution in medical settings, providing essential hydration, electrolytes, and calories to patients. This article delves into the market dynamics and financial trajectory of this product, exploring its production, distribution, market demand, and financial performance.

Product Overview

5% Dextrose and 0.45% Sodium Chloride Injection is a sterile and nonpyrogenic solution containing 5 grams of dextrose monohydrate and 0.45 grams of sodium chloride per 100 mL of water for injection. This solution is hypertonic, with an osmolarity of 406 mOsmol/L and a caloric value of 170 kcal/L[4].

Market Demand

The demand for 5% Dextrose and 0.45% Sodium Chloride Injection is driven by several factors:

Clinical Use

This solution is commonly used in hospitals and clinical settings for patient hydration, especially in cases where patients require both glucose and electrolytes. Its use is widespread in various medical specialties, including surgery, intensive care, and emergency medicine.

Patient Population

The patient population requiring this solution includes those undergoing surgery, critically ill patients, and individuals with dehydration or electrolyte imbalances. The growing number of hospital admissions and surgical procedures globally contributes to the steady demand for this product.

Production and Distribution

Manufacturers

Companies like ICU Medical Canada Inc. and other pharmaceutical firms are key players in the production of 5% Dextrose and 0.45% Sodium Chloride Injection. These manufacturers ensure the solution meets stringent quality and safety standards[1][2].

Container Types and Sizes

The solution is available in various container sizes, including 250 mL, 500 mL, and 1000 mL, and is packaged in flexible PVC/DEHP containers. The shelf life of these solutions ranges from 18 to 24 months, depending on the container size[2].

Market Dynamics

Competitive Landscape

The market for intravenous solutions is competitive, with multiple manufacturers offering similar products. However, the quality, reliability, and brand reputation of companies like ICU Medical play a significant role in market share.

Regulatory Environment

The production and distribution of 5% Dextrose and 0.45% Sodium Chloride Injection are heavily regulated by health authorities such as the FDA and Health Canada. Compliance with these regulations is crucial for maintaining market presence[1][4].

Financial Performance

Revenue Streams

The revenue for 5% Dextrose and 0.45% Sodium Chloride Injection comes primarily from hospital and healthcare facility purchases. The pricing of these solutions can vary based on container size, volume of purchase, and geographic location.

Cost Structure

The cost structure includes raw material costs, manufacturing expenses, distribution costs, and regulatory compliance expenditures. The use of flexible PVC/DEHP containers, which are more cost-effective than glass containers, helps in managing production costs[2].

Market Growth

The market for intravenous solutions, including 5% Dextrose and 0.45% Sodium Chloride Injection, is expected to grow due to increasing healthcare needs and advancements in medical treatments. This growth is driven by an aging population, rising healthcare expenditures, and the expansion of healthcare services in developing countries.

Financial Trajectory

Historical Performance

Historically, the financial performance of companies manufacturing 5% Dextrose and 0.45% Sodium Chloride Injection has been stable, with steady revenue streams from consistent demand.

Future Outlook

The future outlook for this product is positive, with anticipated growth in the healthcare sector. As healthcare systems continue to evolve and expand, the demand for essential intravenous solutions like 5% Dextrose and 0.45% Sodium Chloride Injection is expected to increase.

Key Players and Market Share

ICU Medical

ICU Medical is a significant player in the market, known for its high-quality intravenous solutions. The company's financial performance is influenced by its ability to maintain market share and adapt to changing regulatory and market conditions[2].

Other Manufacturers

Other manufacturers, such as Baxter International and B. Braun, also play important roles in the market. The competitive landscape is characterized by these companies' efforts to innovate and improve their product offerings.

Challenges and Opportunities

Supply Chain Disruptions

Supply chain disruptions, such as those caused by the COVID-19 pandemic, can impact the production and distribution of 5% Dextrose and 0.45% Sodium Chloride Injection. Companies must be prepared to mitigate these risks to maintain market stability.

Innovations and Product Development

Innovations in packaging, formulation, and delivery systems present opportunities for growth. For example, the development of more sustainable packaging materials or the introduction of new formulations could enhance market position.

Conclusion

The market for 5% Dextrose and 0.45% Sodium Chloride Injection is driven by strong clinical demand and supported by a robust production and distribution network. As the healthcare sector continues to grow, the financial trajectory for this product is expected to remain positive.

Key Takeaways

  • Strong Clinical Demand: The solution is widely used in various medical specialties.
  • Regulatory Compliance: Adherence to health authority regulations is crucial.
  • Competitive Market: Multiple manufacturers compete in the market.
  • Financial Stability: The product generates steady revenue streams.
  • Growth Potential: Anticipated growth in the healthcare sector supports future demand.

FAQs

What are the primary uses of 5% Dextrose and 0.45% Sodium Chloride Injection?

The primary uses include patient hydration, providing glucose and electrolytes, especially in surgical, intensive care, and emergency medicine settings.

Who are the key manufacturers of this solution?

Key manufacturers include ICU Medical Canada Inc., Baxter International, and B. Braun.

What are the different container sizes available for this solution?

The solution is available in 250 mL, 500 mL, and 1000 mL container sizes.

What is the shelf life of 5% Dextrose and 0.45% Sodium Chloride Injection?

The shelf life ranges from 18 to 24 months, depending on the container size.

How does the regulatory environment impact the market for this product?

The regulatory environment, governed by health authorities like the FDA and Health Canada, ensures compliance with quality and safety standards, which is crucial for market presence.

Sources

  1. Health Canada: Details for: 5% DEXTROSE AND 0.45% SODIUM CHLORIDE[1].
  2. ICU Medical: 5% Dextrose and 0.45% Sodium Chloride Injection, USP[2].
  3. Oxford Journals: Stability of milrinone in 0.45 % sodium chloride ...[3].
  4. DailyMed: 5% Dextrose and 0.45% Sodium Chloride Injection, USP[4].
  5. ICU Medical: Potassium Chloride in 5% Dextrose and 0.45% Sodium Chloride Injection, USP[5].

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