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Last Updated: March 25, 2025

DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER Drug Patent Profile


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When do Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container patents expire, and when can generic versions of Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container launch?

Dextrose 2.5% And Sodium Chloride 0.2% In Plastic Container is a drug marketed by B Braun and is included in one NDA.

The generic ingredient in DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% 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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  • What is the 5 year forecast for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER?
  • What are the global sales for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER?
  • What is Average Wholesale Price for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER?
Summary for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
Drug patent expirations by year for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
Pharmacology for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

US Patents and Regulatory Information for DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
B Braun DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER dextrose; sodium chloride INJECTABLE;INJECTION 019631-002 Feb 24, 1988 RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 1 of 1 entries

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 for fluid, electrolyte, and caloric replenishment. This article delves into the market dynamics and financial trajectory of this drug, exploring its indications, market demand, supply chain, and potential financial implications.

Indications and Usage

Clinical Use

Dextrose 2.5% and Sodium Chloride 0.45% Injection is indicated as a source of water, electrolytes, and calories. It is particularly useful in clinical settings where patients require fluid and electrolyte replenishment, such as in cases of dehydration, surgical procedures, and certain metabolic disorders[1][3][5].

Patient Populations

The solution is used across various patient populations, including adults, pediatric patients, and geriatric patients. However, special caution is advised in certain groups, such as patients with congestive heart failure, severe renal insufficiency, and those at risk of hypokalemia[1][3].

Market Demand

Clinical Necessity

Given its broad indications, the demand for Dextrose 2.5% and Sodium Chloride 0.45% Injection remains consistent. It is a staple in many healthcare settings, including hospitals, clinics, and emergency departments.

Market Trends

The global market for intravenous solutions is growing due to increasing healthcare needs, particularly in regions with aging populations and rising incidence of chronic diseases. This trend is expected to drive the demand for Dextrose 2.5% and Sodium Chloride 0.45% Injection[4].

Supply Chain and Availability

Manufacturing and Distribution

The solution is manufactured by several pharmaceutical companies and distributed through various channels, including wholesalers and direct ship suppliers. The supply chain is generally robust, but occasional manufacturing delays and supply chain disruptions can impact availability[4].

Packaging and Storage

The solution is available in single-dose, flexible containers of 250 mL, 500 mL, and 1000 mL. The containers are made from specially formulated polyvinyl chloride, which ensures the safety and integrity of the solution during storage and use[1][3].

Financial Trajectory

Revenue Streams

The revenue generated from Dextrose 2.5% and Sodium Chloride 0.45% Injection comes from sales to healthcare institutions, wholesalers, and distributors. The pricing is generally competitive, reflecting the solution's widespread use and the presence of multiple manufacturers.

Cost Factors

The cost of production includes raw materials, manufacturing, packaging, and distribution expenses. The solution's relatively simple composition and large-scale production help keep costs manageable. However, fluctuations in raw material prices and manufacturing costs can impact profitability[3].

Market Competition

The market for intravenous solutions is competitive, with several major players. Companies like Baxter and others compete based on product quality, pricing, and supply chain reliability. This competition can influence pricing strategies and market share[4].

Regulatory Environment

Safety and Efficacy

Regulatory bodies closely monitor the safety and efficacy of Dextrose 2.5% and Sodium Chloride 0.45% Injection. Adverse reactions, such as fluid overload, hypokalemia, and hyperglycemia, are carefully documented and managed through warnings and precautions[1][3].

Compliance

Manufacturers must comply with strict guidelines regarding the composition, packaging, and storage of the solution. Non-compliance can result in regulatory actions, affecting the financial trajectory of the product.

Patient Safety and Monitoring

Clinical Monitoring

Patients receiving Dextrose 2.5% and Sodium Chloride 0.45% Injection require close monitoring of serum electrolyte concentrations, blood glucose levels, and fluid balance. This monitoring is crucial to prevent complications such as hypokalemia, hyperglycemia, and fluid overload[1][3].

Adverse Reactions

Adverse reactions, including febrile responses, infections, and venous thrombosis, must be promptly identified and managed. The risk of these reactions can impact the product's reputation and market demand.

Pediatric and Geriatric Use

Special Considerations

In pediatric patients, especially neonates, close monitoring is necessary to avoid hypo- or hyperglycemia and electrolyte imbalances. In geriatric patients, the risk of hyponatremia and fluid overload is higher, requiring cautious dose selection and monitoring[1][3].

Veterinary Use

Animal Health

While primarily used in human healthcare, Dextrose 2.5% and Sodium Chloride 0.45% Injection also has applications in veterinary medicine. The solution is used with similar precautions and monitoring as in human patients[3].

Supply Chain Disruptions

Impact on Availability

Supply chain disruptions, such as manufacturing delays or distribution issues, can significantly impact the availability of Dextrose 2.5% and Sodium Chloride 0.45% Injection. These disruptions can lead to shortages, affecting both healthcare providers and patients[4].

Financial Implications of Supply Chain Disruptions

Revenue Impact

Supply chain disruptions can result in lost revenue for manufacturers and distributors. The inability to meet demand can also lead to a loss of market share and reputation.

Cost of Mitigation

Efforts to mitigate supply chain disruptions, such as increasing production capacity or diversifying suppliers, can incur additional costs. These costs must be balanced against the potential revenue losses.

Market Forecast

Growth Prospects

The market for Dextrose 2.5% and Sodium Chloride 0.45% Injection is expected to grow steadily, driven by increasing healthcare needs and the solution's essential role in clinical practice.

Challenges and Opportunities

While the market presents opportunities for growth, challenges such as supply chain disruptions, regulatory compliance, and competition must be navigated. Innovations in packaging, manufacturing, and distribution can provide competitive advantages.

Key Takeaways

  • Consistent Demand: The solution is a clinical necessity, ensuring consistent demand.
  • Regulatory Compliance: Strict adherence to regulatory guidelines is crucial for maintaining market presence.
  • Supply Chain Management: Effective supply chain management is vital to avoid disruptions and ensure continuous availability.
  • Patient Safety: Close monitoring of patients is essential to prevent adverse reactions.
  • Market Competition: The market is competitive, with multiple manufacturers vying for market share.

FAQs

What are the primary indications for Dextrose 2.5% and Sodium Chloride 0.45% Injection?

The primary indications include fluid, electrolyte, and caloric replenishment in various clinical settings.

What are the potential adverse reactions associated with Dextrose 2.5% and Sodium Chloride 0.45% Injection?

Potential adverse reactions include fluid overload, hypokalemia, hyperglycemia, febrile responses, infections, and venous thrombosis.

How is Dextrose 2.5% and Sodium Chloride 0.45% Injection packaged and stored?

The solution is packaged in single-dose, flexible containers made from polyvinyl chloride and stored under specified conditions to maintain its integrity.

What are the special considerations for pediatric and geriatric patients receiving Dextrose 2.5% and Sodium Chloride 0.45% Injection?

Pediatric patients, especially neonates, require close monitoring to avoid hypo- or hyperglycemia and electrolyte imbalances. Geriatric patients are at higher risk of hyponatremia and fluid overload, necessitating cautious dose selection and monitoring.

How do supply chain disruptions impact the availability and financial trajectory of Dextrose 2.5% and Sodium Chloride 0.45% Injection?

Supply chain disruptions can lead to shortages, affecting revenue and market share. Efforts to mitigate these disruptions can incur additional costs.

Sources

  1. DailyMed: Dextrose monohydrate, sodium chloride injection, solution.
  2. PubMed: Stability study of methotrexate in 0.9% sodium chloride injection and 5% dextrose injection.
  3. Zoetis US: Veterinary 2.5% Dextrose and 0.45% Sodium Chloride Injection, USP.
  4. USHP Supply Availability Report: April 2nd, 2024.
  5. DailyMed: DEXTROSE AND SODIUM CHLORIDE injection, solution.

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