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Last Updated: December 22, 2024

SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER Drug Patent Profile


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When do Sodium Chloride 0.45% In Plastic Container patents expire, and when can generic versions of Sodium Chloride 0.45% In Plastic Container launch?

Sodium Chloride 0.45% In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Hospira, Icu Medical Inc, and Miles. and is included in eleven NDAs.

The generic ingredient in SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER is sodium chloride. There are one thousand four hundred and seventy-two drug master file entries for this compound. Twenty-five suppliers are listed for this compound. Additional details are available on the sodium chloride profile page.

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Summary for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Drug patent expirations by year for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
Pharmacology for SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER

US Patents and Regulatory Information for 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 SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 018184-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Miles SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 018503-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER sodium chloride INJECTABLE;INJECTION 208122-001 Jul 23, 2018 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

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

Market Dynamics and Financial Trajectory for Sodium Chloride 0.45% Injection in Plastic Containers

Introduction to Sodium Chloride 0.45% Injection

Sodium chloride injections, particularly the 0.45% concentration, are crucial in medical settings for fluid and electrolyte replenishment. These solutions are sterile, nonpyrogenic, and designed for intravenous administration, making them essential for patient hydration and electrolyte balance.

Market Size and Growth Projections

The global sodium chloride injection market has been experiencing steady growth. As of 2020, the market size was valued at USD 2310 million. It is projected to reach USD 3621 million by 2032, indicating a significant increase in demand over the forecast period[1].

Compound Annual Growth Rate (CAGR)

The sodium chloride injection market is expected to exhibit a Compound Annual Growth Rate (CAGR) of 3.7% by 2032. This growth rate is driven by increasing medical needs and the expanding use of sodium chloride injections in various clinical applications[1].

Driving Factors of the Market

Several factors are driving the growth of the sodium chloride injection market:

Patient Hydration and Electrolyte Balance

Sodium chloride injections are vital for maintaining patient hydration and electrolyte balance, especially in cases where patients are unable to take fluids orally. This need is a primary driver of the market[1].

Intravenous Medication Administration

The use of sodium chloride injections as a vehicle for administering intravenous medications also contributes to the market's growth. These solutions provide a compatible medium for many drugs, enhancing their delivery and efficacy[1].

Key Players in the Market

The sodium chloride injection market is dominated by several key players:

  • Kelun Group
  • Baxter
  • Fresenius Kabi
  • Shijiazhuang No.4 Pharmaceutical
  • CR Double-Crane

These companies are instrumental in manufacturing and distributing sodium chloride injections globally[1].

Product Variations and Concentrations

Sodium chloride injections come in various concentrations, with 0.45% being one of the most commonly used:

Concentration and Composition

The 0.45% sodium chloride injection is hypotonic, containing 4.5 g/L of sodium chloride (NaCl) with an osmolarity of 154 mOsmol/L. It is suitable for parenteral maintenance or replacement of water and electrolyte requirements, especially when the sodium loss is less than the chloride loss[3].

Packaging and Storage

These injections are typically packaged in flexible plastic containers made from clear multilayer polyolefin plastic film. They must be stored at controlled room temperatures (20 to 25°C or 68 to 77°F) and protected from freezing. The shelf life varies depending on the container size, ranging from 18 to 24 months[2][5].

Applications of Sodium Chloride 0.45% Injection

Intravenous Fluid Therapy

Sodium chloride 0.45% injections are widely used in intravenous fluid therapy to replenish fluids and electrolytes in patients. This application is critical in hospital settings, clinics, and emergency medical services[4].

Ophthalmic Irrigation

The 0.45% concentration is also used in ophthalmic surgeries and for lens care solutions, highlighting its versatility beyond general fluid therapy[4].

End Users and Distribution Channels

End Users

The primary end users of sodium chloride 0.45% injections include:

  • Hospitals
  • Clinics
  • Emergency Medical Services
  • Nursing Homes
  • Ambulatory Surgical Centers

These institutions rely heavily on these injections for patient care[4].

Distribution Channels

The distribution channels for sodium chloride injections include:

  • Hospitals
  • Distributors
  • Retail Pharmacies
  • Online Retailers
  • Direct-to-Patient

This diverse distribution network ensures widespread availability of the product[4].

Financial Performance and Projections

The financial trajectory of the sodium chloride injection market is positive, driven by the increasing demand for these solutions. Here are some key financial highlights:

Market Value

The market value is expected to grow from USD 2310 million in 2020 to USD 3621 million by 2032, reflecting a significant increase in revenue over the forecast period[1].

Revenue Streams

The revenue streams for manufacturers come from the sale of these injections to various healthcare institutions and through distribution channels. The market's growth is also influenced by the expanding use of these solutions in different medical applications.

Challenges and Opportunities

Challenges

Despite the growth, the market faces challenges such as competition from other fluid and electrolyte solutions and regulatory hurdles. Manufacturers must comply with stringent quality and safety standards, which can be costly and time-consuming.

Opportunities

The increasing adoption of sodium chloride 0.45% injections in ophthalmic surgeries and other specialized medical procedures presents significant opportunities for growth. Expanding into new markets and developing innovative packaging solutions can further enhance market share.

Regulatory Considerations

Manufacturers of sodium chloride injections must adhere to strict regulatory guidelines to ensure the products are sterile, nonpyrogenic, and safe for use. This includes compliance with FDA regulations and international standards for pharmaceutical products[2][3].

Conclusion

The market for sodium chloride 0.45% injections in plastic containers is poised for continued growth, driven by increasing medical needs and the expanding use of these solutions in various clinical applications. Key players in the market are well-positioned to capitalize on this growth, but they must navigate regulatory challenges and competitive pressures.

Key Takeaways

  • The global sodium chloride injection market is projected to reach USD 3621 million by 2032.
  • The market is expected to exhibit a CAGR of 3.7% by 2032.
  • Patient hydration and electrolyte balance, along with intravenous medication administration, are key drivers of the market.
  • Major players include Kelun Group, Baxter, Fresenius Kabi, Shijiazhuang No.4 Pharmaceutical, and CR Double-Crane.
  • The 0.45% concentration is hypotonic and widely used in intravenous fluid therapy and ophthalmic surgeries.

FAQs

What is the expected market size of the sodium chloride injection market by 2032?

The global sodium chloride injection market is expected to reach USD 3621 million by 2032[1].

What is the CAGR of the sodium chloride injection market?

The sodium chloride injection market is expected to exhibit a CAGR of 3.7% by 2032[1].

What are the primary applications of sodium chloride 0.45% injections?

Primary applications include intravenous fluid therapy, ophthalmic irrigation, and as a vehicle for intravenous medication administration[2][4].

Who are the key players in the sodium chloride injection market?

Key players include Kelun Group, Baxter, Fresenius Kabi, Shijiazhuang No.4 Pharmaceutical, and CR Double-Crane[1].

What are the storage requirements for sodium chloride 0.45% injections?

These injections must be stored at controlled room temperatures (20 to 25°C or 68 to 77°F) and protected from freezing[2][5].

Sources

  1. Business Research Insights, "Sodium Chloride Injection Market Size, Share | Overview, 2032"
  2. FDA, "0.45% Sodium Chloride Injection, USP"
  3. Baxter, "Sodium Chloride Injection, USP in VIAFLEX Plastic Container"
  4. Market Research Future, "Physiological Saline Market Size, Growth, Trends, Report 2032"
  5. ICU Medical, "0.45% Sodium Chloride Injection, USP"

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