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Last Updated: December 22, 2024

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container, and when can generic versions of Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container launch?

Dextrose 2.5% And Sodium Chloride 0.45% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, and Hospira. and is included in five NDAs.

The generic ingredient in DEXTROSE 2.5% 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 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 2.5% 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
B Braun DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 018030-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 211190-001 Dec 20, 2019 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
B Braun DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-004 Feb 24, 1988 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 016697-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Dextrose 2.5% and Sodium Chloride 0.45% Injection

Introduction

Dextrose 2.5% and Sodium Chloride 0.45% Injection is a widely used intravenous solution, indicated as a source of water, electrolytes, and calories. This solution is crucial in various clinical settings, including hospitals and outpatient care facilities. Here, we will delve into the market dynamics and financial trajectory of this essential medical product.

Market Demand and Usage

The demand for Dextrose 2.5% and Sodium Chloride 0.45% Injection is driven by its versatility in clinical applications. It is used in adults and pediatric patients for fluid and electrolyte replenishment, caloric supply, and hydration[2][4].

  • Clinical Indications: The solution is indicated for patients requiring fluid and electrolyte replacement, particularly in cases of dehydration, surgical procedures, and critical care settings.
  • Patient Population: The solution is used across a broad patient population, including neonates, children, and adults, making it a staple in many healthcare facilities.

Competitive Landscape

The market for intravenous solutions is competitive, with several manufacturers producing similar products.

  • Key Players: Companies like Baxter, ICU Medical, and others are prominent in the market, offering various formulations of dextrose and sodium chloride injections[3][5].
  • Product Differentiation: While the core composition of these solutions is similar, differences in concentration, packaging, and distribution channels can influence market share.

Supply Chain and Availability

The availability of Dextrose 2.5% and Sodium Chloride 0.45% Injection can be affected by several factors.

  • Manufacturing and Distribution: Supply chain disruptions, such as manufacturing delays or third-party supplier issues, can impact the availability of these solutions. For instance, recent reports indicate supply limitations due to manufacturing delays and increased demand[3].
  • Packaging and Storage: The solution is typically packaged in flexible plastic containers, which must meet strict safety and quality standards. The material of the container, such as polyvinyl chloride (PVC), can also affect the product's safety profile[1].

Financial Performance

The financial performance of Dextrose 2.5% and Sodium Chloride 0.45% Injection is influenced by several factors, including market demand, competition, and supply chain efficiency.

  • Revenue Streams: The revenue generated from this product is substantial due to its widespread use in healthcare settings. Manufacturers often report steady sales figures, with fluctuations based on market conditions and supply chain stability.
  • Cost Structure: The cost of production includes raw materials, manufacturing, packaging, and distribution. Any disruptions in these areas can impact the profitability of the product.
  • Pricing Strategies: Pricing is competitive and can vary based on the region, distributor, and specific formulation. Manufacturers may adjust prices in response to market conditions and regulatory changes.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of Dextrose 2.5% and Sodium Chloride 0.45% Injection.

  • FDA Approval: These solutions must meet strict FDA guidelines, including safety and efficacy standards. Any changes in regulatory requirements can impact the market[1][2].
  • Compliance: Manufacturers must comply with USP standards for biological tests and tissue culture toxicity studies to ensure the safety of the plastic containers used[1].

Safety and Efficacy Concerns

Safety and efficacy are paramount in the use of Dextrose 2.5% and Sodium Chloride 0.45% Injection.

  • Potential Risks: Excessive administration can lead to significant hypokalemia, fluid overload, and other electrolyte imbalances. Patients with congestive heart failure, severe renal insufficiency, and those at risk of sodium retention must be carefully monitored[1][4].
  • Monitoring and Management: Healthcare providers must closely monitor patients receiving this solution to avoid adverse effects, particularly in vulnerable populations such as neonates and elderly patients.

Pediatric and Geriatric Use

The solution's use in pediatric and geriatric populations requires special consideration.

  • Pediatric Use: Neonates and children are at increased risk of developing hypo- or hyperglycemia and electrolyte imbalances. Close monitoring is essential to avoid long-term adverse effects[4].
  • Geriatric Use: Elderly patients are at higher risk of developing hyponatremia and other electrolyte imbalances. Dose selection should be cautious, reflecting the patient's renal function and other health conditions[4].

Future Outlook

The future outlook for Dextrose 2.5% and Sodium Chloride 0.45% Injection is positive, driven by ongoing demand in healthcare settings.

  • Market Growth: The market is expected to grow as healthcare needs increase globally. Innovations in packaging and formulation could further enhance market share.
  • Challenges and Opportunities: Manufacturers must navigate supply chain challenges and regulatory changes while capitalizing on opportunities to improve product safety and efficacy.

Key Takeaways

  • Widespread Use: Dextrose 2.5% and Sodium Chloride 0.45% Injection is a critical component in clinical care.
  • Competitive Market: The market is competitive, with multiple manufacturers offering similar products.
  • Regulatory Compliance: Strict regulatory standards must be met to ensure safety and efficacy.
  • Safety Monitoring: Close monitoring is necessary to avoid adverse effects, particularly in vulnerable populations.
  • Future Growth: The market is expected to grow, driven by increasing healthcare needs.

Frequently Asked Questions (FAQs)

Q: What are the primary indications for Dextrose 2.5% and Sodium Chloride 0.45% Injection? A: The solution is indicated as a source of water, electrolytes, and calories for fluid and electrolyte replenishment and caloric supply[2][4].

Q: What are the potential risks associated with the administration of this solution? A: Potential risks include significant hypokalemia, fluid overload, and other electrolyte imbalances. Patients with certain health conditions must be carefully monitored[1][4].

Q: How does the solution affect pediatric patients? A: Pediatric patients, especially neonates, are at increased risk of developing hypo- or hyperglycemia and electrolyte imbalances. Close monitoring is essential[4].

Q: What are the regulatory requirements for this solution? A: The solution must meet FDA guidelines and USP standards for safety and efficacy, including biological tests and tissue culture toxicity studies[1][2].

Q: What is the expected market growth for Dextrose 2.5% and Sodium Chloride 0.45% Injection? A: The market is expected to grow driven by increasing healthcare needs globally, despite challenges in supply chain and regulatory compliance.

Cited Sources

  1. DailyMed: Veterinary 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP.
  2. FDA: Dextrose and Sodium Chloride Injections USP.
  3. Baxter: USHP Supply Availability Report - March 12th, 2024.
  4. DailyMed: Dextrose monohydrate, sodium chloride injection, solution.
  5. ICU Medical: 5% Dextrose and 0.45% Sodium Chloride Injection, USP.

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