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Last Updated: April 3, 2025

AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE Drug Patent Profile


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Which patents cover Ammonium Chloride 0.9% In Normal Saline, and when can generic versions of Ammonium Chloride 0.9% In Normal Saline launch?

Ammonium Chloride 0.9% In Normal Saline is a drug marketed by Mcgaw and is included in one NDA.

The generic ingredient in AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE is ammonium chloride. There are forty drug master file entries for this compound. Additional details are available on the ammonium chloride profile page.

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Summary for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Drug patent expirations by year for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
Recent Clinical Trials for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

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SponsorPhase
Children's Mercy Hospital Kansas CityPhase 1
American Heart AssociationPhase 1
University Hospitals Cleveland Medical CenterN/A

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US Patents and Regulatory Information for AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Mcgaw AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE ammonium chloride INJECTABLE;INJECTION 006580-001 Approved Prior to Jan 1, 1982 DISCN 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
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Market Dynamics and Financial Trajectory of 0.9% Sodium Chloride (Normal Saline) Solutions

Introduction

0.9% Sodium Chloride, commonly known as normal saline, is a crucial fluid solution in medical settings, used for various purposes including hydration, electrolyte balance, and as a vehicle for drug administration. Here, we delve into the market dynamics and financial trajectory of this essential medical product.

Market Size and Projections

The global market for 0.9% Sodium Chloride sterile saline is experiencing significant growth. As of 2023, the market size was valued at USD 2.2 billion and is projected to reach USD 5.5 billion by 2031, indicating a robust growth trajectory[1].

Segmentation of the Market

The market is segmented based on several key factors:

  • Type: This includes flexible bags, plastic bottles, and glass bottles. Flexible containers, such as those made from PVC/DEHP, are increasingly popular due to their convenience and shelf life of up to 24 months[2].
  • Application: The primary applications are in hospitals and clinics, where normal saline is used extensively for patient care.
  • Geographical Regions: North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa are the key regions. North America dominates the market due to its well-established healthcare infrastructure[3][4].

Drivers of Market Growth

Several factors are driving the growth of the 0.9% Sodium Chloride market:

  • Increasing Prevalence of Diarrhea: Diarrhea, especially in children, is a significant driver. According to the World Health Organization (WHO), diarrhea is the second leading cause of death in children under five years old, resulting in around 525,000 deaths annually[3].
  • Rising Number of Hospital Admissions and Surgical Procedures: The increasing number of hospital admissions and surgical procedures globally contributes to the higher demand for normal saline solutions. For instance, in the U.S., around 200 million liters of saline are sold annually[4].
  • Improving Healthcare Facilities: The expansion and improvement of healthcare facilities, particularly in the Asia-Pacific region, are also boosting market growth[4].

Market Challenges

Despite the growth, the market faces several challenges:

  • Supply Chain Disruptions: Historical events like Hurricane Maria have highlighted the vulnerability of the supply chain, leading to shortages of saline solutions. This has prompted manufacturers to invest in expanding their production capacities[4].
  • Regulatory Compliance: Manufacturers must comply with stringent regulatory requirements, which can sometimes act as a barrier to entry or expansion.

Financial Trajectory

The financial outlook for the 0.9% Sodium Chloride market is promising:

  • Compound Annual Growth Rate (CAGR): The market is expected to grow at a CAGR of 6.9% from 2023 to 2030, reaching a market size of USD 5.48 billion by 2030[4].
  • Regional Performance: North America continues to dominate the market, with a significant share valued at USD 1.26 billion in 2022. The Asia-Pacific region is expected to hold a prominent position due to its growing patient population and improving healthcare infrastructure[4].

Key Applications and Uses

Normal saline is used in a variety of medical applications:

  • Dehydration and Electrolyte Imbalance: It is used to treat dehydration and maintain electrolyte balance in patients.
  • Wound Dressing and Sepsis: Normal saline is used in wound care and as a treatment for sepsis, which affects around 1 to 50 per 1,000 live births annually[4].
  • Surgical Procedures: It is commonly used as an intravenous fluid during surgical procedures.

Industry Insights and Quotes

"The increasing prevalence of diarrhea worldwide will be a prominent growth driver for this market," shares Fortune Business Insights™ in its report[3].

Statistical Highlights

  • Global Consumption: Over 1 million liters of 0.9% sodium chloride are administered to patients daily across the globe[4].
  • Regional Market Share: North America dominated the market with a share valued at USD 1.10 billion in 2019 and is expected to retain its leading position[3].

Regulatory Support

Government and regulatory bodies play a crucial role in supporting the market:

  • European Union (EU) Support: Strong support from regulatory authorities in the EU, such as recommendations from the National Institute of Health and Care Excellence (NICE) and the European Society of Intensive Care Medicine (ESICM), aids market growth in Europe[4].

Conclusion

The 0.9% Sodium Chloride market is poised for significant growth driven by increasing medical needs, improving healthcare infrastructure, and regulatory support. As the market continues to expand, manufacturers are likely to invest more in production capacity and innovation to meet the rising demand.

Key Takeaways

  • The global 0.9% Sodium Chloride market is projected to reach USD 5.5 billion by 2031.
  • North America dominates the market due to its well-established healthcare infrastructure.
  • Increasing prevalence of diarrhea and rising hospital admissions are key drivers of market growth.
  • The market faces challenges such as supply chain disruptions and regulatory compliance.
  • Normal saline is used extensively in various medical applications, including dehydration, wound dressing, and surgical procedures.

FAQs

Q: What is the projected market size of the 0.9% Sodium Chloride market by 2031? A: The market is expected to reach USD 5.5 billion by 2031[1].

Q: Which region dominates the 0.9% Sodium Chloride market? A: North America dominates the market due to its strong healthcare infrastructure[3][4].

Q: What are the primary drivers of the 0.9% Sodium Chloride market growth? A: The increasing prevalence of diarrhea, rising number of hospital admissions, and improving healthcare facilities are key drivers[3][4].

Q: What are the common applications of 0.9% Sodium Chloride in medical settings? A: It is used for dehydration, electrolyte imbalance, wound dressing, sepsis, and as a vehicle for drug administration[4].

Q: How does regulatory support impact the 0.9% Sodium Chloride market? A: Regulatory bodies such as NICE and ESICM provide recommendations that support market growth, especially in Europe[4].

Sources

  1. Market Research Intellect - 0.9% Sodium Chloride Sterile Saline Market Size and Projections
  2. ICU Medical - 0.9% Sodium Chloride Injection, USP
  3. GlobeNewswire - Normal Saline for Parenteral Use Market to Hit USD 3.71 Billion by 2026
  4. Fortune Business Insights - Normal Saline for Parenteral Use Market Growth Report [2030]

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