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Last Updated: December 23, 2024

DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 10% And Sodium Chloride 0.9% In Plastic Container patents expire, and when can generic versions of Dextrose 10% And Sodium Chloride 0.9% In Plastic Container launch?

Dextrose 10% And Sodium Chloride 0.9% In Plastic Container is a drug marketed by B Braun and Baxter Hlthcare and is included in three NDAs.

The generic ingredient in DEXTROSE 10% AND SODIUM CHLORIDE 0.9% 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 0.9% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 10% AND 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
B Braun DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018047-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-015 Feb 24, 1988 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 016696-001 Approved Prior to Jan 1, 1982 DISCN 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 0.9% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextrose 10% and Sodium Chloride 0.9% Injection

Introduction to Dextrose and Sodium Chloride Injections

Dextrose and Sodium Chloride injections are widely used in medical settings for fluid and electrolyte replenishment, as well as for providing calories and hydration. These solutions are available in various concentrations, catering to different clinical needs.

Market Overview

The global dextrose injection market is a significant segment within the broader pharmaceutical industry. Here are some key points that outline the market dynamics:

Market Size and Growth

The global dextrose injection market was valued at US$ 9,512.7 million in 2020 and is projected to grow at a Compound Annual Growth Rate (CAGR) of 5.7% from 2020 to 2027[3].

Regional Market Share

The market is distributed across various regions, with each region contributing differently to the overall market share. Understanding regional dynamics is crucial for market players to strategize their expansion and distribution[3].

Drivers of Market Growth

Increasing Incidence of Diabetes and Hypoglycemia

The rising incidence of diabetes and associated conditions such as hypoglycemia is a major driver of the market. According to the World Health Organization, the number of people with diabetes increased from 108 million in 1980 to 422 million in 2014. Hypoglycemia, often related to diabetes treatment, also contributes to the demand for dextrose injections[3].

Clinical Indications

Dextrose and Sodium Chloride injections are indicated for use in adults and pediatric patients as sources of electrolytes, calories, and water for hydration. These solutions are particularly useful in treating dehydration, hypoglycemia, and other conditions requiring rapid fluid and electrolyte replenishment[2].

Product Variations and Concentrations

Concentrations Available

Dextrose 10% and Sodium Chloride 0.9% injection is one of the many variations available. Other common concentrations include:

  • 5% Dextrose and 0.9% Sodium Chloride
  • 5% Dextrose and 0.45% Sodium Chloride
  • 5% Dextrose and 0.33% Sodium Chloride
  • 5% Dextrose and 0.2% Sodium Chloride Each concentration is tailored to meet specific clinical requirements[2][5].

Dosage Forms and Strengths

These solutions are available in various container sizes, including 250 mL, 500 mL, and 1000 mL single-dose, flexible containers. This flexibility in packaging caters to different patient needs and clinical settings[5].

Financial Trajectory

Revenue Projections

Given the CAGR of 5.7%, the market is expected to see significant revenue growth over the forecast period. This growth is driven by increasing demand due to the rising incidence of diabetes and other conditions requiring dextrose and electrolyte replenishment[3].

Market Segmentation

The market can be segmented based on product type, application, and geography. Understanding these segments helps in identifying key revenue streams and areas of potential growth.

Competitive Landscape

Key Players

The market for dextrose and sodium chloride injections includes several key players, such as pharmaceutical companies and medical solution providers. Companies like Hospira Inc., a Pfizer company, play a significant role in manufacturing and distributing these solutions[4].

Product Differentiation

While the core ingredients remain the same, differentiation often comes from the concentration of dextrose and sodium chloride, packaging options, and the quality of the solution. Companies also focus on extending the expiration dates of their products through stability data evaluation, as seen in the case of FDA extensions for certain lots[4].

Regulatory Environment

FDA Guidelines

The FDA plays a crucial role in regulating these injections, ensuring they meet safety and efficacy standards. The solutions must be sterile, nonpyrogenic, and free from contaminants. Regulatory approvals and extensions, such as those for expiration dates, are critical for market stability[2][4].

Clinical Usage and Safety

Indications and Contraindications

Dextrose and Sodium Chloride injections are indicated for fluid and electrolyte replenishment and caloric supply. However, they are contraindicated in cases where the administration of sodium or chloride could be clinically detrimental[2].

Safety Profile

These solutions are generally safe and effective when used as indicated. However, it is important to monitor patients for any adverse reactions, especially in pediatric patients and those with specific electrolyte imbalances[2].

Future Outlook

Emerging Trends

The market is expected to be influenced by emerging trends such as the increasing use of home healthcare services and the development of more convenient packaging options. Additionally, advancements in medical technology could lead to more efficient and safe administration methods.

Challenges and Opportunities

Despite the growth potential, the market faces challenges such as competition from alternative treatments and the need for continuous regulatory compliance. However, the increasing demand driven by demographic changes and the expansion into new markets present significant opportunities for growth.

Key Takeaways

  • The global dextrose injection market is valued at US$ 9,512.7 million and is expected to grow at a CAGR of 5.7% from 2020 to 2027.
  • The market is driven by the increasing incidence of diabetes and hypoglycemia.
  • Dextrose 10% and Sodium Chloride 0.9% injection is one of the key products in this market, used for fluid and electrolyte replenishment.
  • The market is segmented based on product type, application, and geography.
  • Regulatory compliance and product differentiation are critical for market success.

FAQs

Q: What is the primary use of Dextrose 10% and Sodium Chloride 0.9% injection? A: The primary use is for fluid and electrolyte replenishment and caloric supply in patients.

Q: What are the common concentrations of Dextrose and Sodium Chloride injections available? A: Common concentrations include 5% Dextrose with various sodium chloride percentages (0.9%, 0.45%, 0.33%, 0.2%) and 10% Dextrose with sodium chloride percentages (0.9%, 0.45%, 0.2%).

Q: What drives the growth of the dextrose injection market? A: The growth is driven by the increasing incidence of diabetes and associated conditions like hypoglycemia.

Q: Who are the key players in the dextrose injection market? A: Key players include pharmaceutical companies such as Hospira Inc., a Pfizer company.

Q: What are the regulatory considerations for Dextrose and Sodium Chloride injections? A: These solutions must meet FDA guidelines, ensuring they are sterile, nonpyrogenic, and safe for use.

Sources

  1. Dextrose and Sodium Chloride Injections USP - DailyMed https://dailymed.nlm.nih.gov/dailymed/fda/fdaDrugXsl.cfm?setid=8e6569ce-9714-497f-a94b-c6975c1d76f6
  2. Dextrose and Sodium Chloride Injections USP - accessdata.fda.gov https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19631s023lbl.pdf
  3. Dextrose Injection Market Size, Trends And Forecast To 2027 - Coherent Market Insights https://www.coherentmarketinsights.com/market-insight/dextrose-injection-market-1835
  4. Extension of the Expiration Date for 10% LMD in 0.9% Sodium Chloride Injection - FDA https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/extension-expiration-date-10-lmd-09-sodium-chloride-injection-dextran-40-sodium-chloride-injection
  5. DEXTROSE AND SODIUM CHLORIDE injection, solution - DailyMed https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=dcbf1907-1841-4afc-ab5d-a9893a2d7256

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