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Last Updated: December 22, 2024

BRONCHO SALINE Drug Patent Profile


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When do Broncho Saline patents expire, and when can generic versions of Broncho Saline launch?

Broncho Saline is a drug marketed by Blairex and is included in one NDA.

The generic ingredient in BRONCHO SALINE 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 BRONCHO SALINE
Drug patent expirations by year for BRONCHO SALINE
Recent Clinical Trials for BRONCHO SALINE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
OM PharmaPhase 4
People's Hospital of Anshun City of Guizhou ProvincePhase 2/Phase 3
SandozPhase 3

See all BRONCHO SALINE clinical trials

US Patents and Regulatory Information for BRONCHO SALINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Blairex BRONCHO SALINE sodium chloride AEROSOL, METERED;INHALATION 019912-001 Sep 3, 1992 DISCN Yes 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

BRONCHO SALINE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Broncho Saline

Introduction

Broncho Saline, often referred to as 0.9% sodium chloride solution, is a widely used medical product in various clinical settings. It is employed for hydration, as an intravenous fluid, and for flushing intravenous lines. Here, we will delve into the market dynamics and financial trajectory of Broncho Saline, highlighting key factors, recent developments, and challenges.

Market Demand and Usage

Broncho Saline is a staple in healthcare, with a consistent and high demand due to its versatile applications. It is used in hospitals, clinics, and other healthcare facilities for patient hydration, intravenous therapy, and as a flushing agent for IV lines. The demand has been further amplified by the COVID-19 pandemic, which increased the need for IV fluids and saline solutions[1].

Supply Chain and Manufacturing

The supply chain for Broncho Saline involves several major manufacturers, including B. Braun Medical Inc., Medline Industries, and HF Acquisition Co LLC. These companies produce various formulations and packaging options for 0.9% sodium chloride solutions. However, recent years have seen disruptions in the supply chain due to manufacturing issues and quality control problems.

Recalls and Quality Issues

There have been several recalls and safety alerts related to Broncho Saline products. For instance, B. Braun Medical Inc. issued a voluntary recall of 0.9% Sodium Chloride for Injection USP due to potential particulate matter and fluid leakage. Similarly, Medline Industries recalled Hudson RCI Addipak Unit Dose Vial, 0.9% Full Normal Saline Solution, due to non-sterility concerns[1].

Financial Trajectory

The financial performance of companies producing Broncho Saline is influenced by several factors, including market demand, production costs, and regulatory compliance.

Revenue and Sales

Despite the challenges, the market for IV fluids and saline solutions has seen steady revenue growth. The consistent demand and essential nature of these products ensure a stable financial base for manufacturers. For example, B. Braun Medical Inc. and other major players have maintained significant revenue streams from their IV solution products.

Cost and Pricing

The pricing of Broncho Saline is influenced by production costs, raw material availability, and regulatory requirements. Recent recalls and quality issues have led to increased costs associated with product recalls, quality control measures, and potential legal liabilities. This can impact the financial margins of manufacturers.

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics and financial trajectory of Broncho Saline.

FDA Guidelines and Alerts

The FDA closely monitors the production and distribution of IV fluids, including Broncho Saline. The agency issues safety alerts and guidelines to ensure product safety and quality. For instance, the FDA has provided recommendations for conservation strategies during shortages of prefilled saline flush syringes, highlighting the importance of maintaining patient care quality[1].

Market Competition

The market for Broncho Saline is competitive, with multiple manufacturers vying for market share.

Key Players

Companies like B. Braun Medical Inc., Medline Industries, and HF Acquisition Co LLC are major players in this market. Each company has its own strengths and weaknesses, and the competitive landscape is driven by factors such as product quality, pricing, and distribution networks.

Global Market Perspective

The global market for IV fluids, including Broncho Saline, is diverse and influenced by regional healthcare needs and regulatory frameworks.

International Demand

The demand for Broncho Saline is not limited to the United States; it is a global product with significant demand in various countries. The COVID-19 pandemic has highlighted the importance of having a robust global supply chain to meet the increased demand for IV fluids and saline solutions.

Challenges and Opportunities

The market for Broncho Saline faces several challenges and opportunities.

Challenges

  • Supply Chain Disruptions: Recent recalls and manufacturing issues have disrupted the supply chain, affecting product availability and patient care.
  • Regulatory Compliance: Ensuring compliance with FDA guidelines and other regulatory requirements is crucial but can be costly and time-consuming.
  • Quality Control: Maintaining high-quality standards is essential to avoid recalls and ensure patient safety.

Opportunities

  • Growing Demand: The consistent and growing demand for IV fluids and saline solutions presents a stable market opportunity.
  • Innovation: Improving product formulations, packaging, and delivery systems can enhance market share and revenue.
  • Global Expansion: Expanding into new markets and regions can provide additional revenue streams.

Key Takeaways

  • Stable Demand: Broncho Saline has a consistent and high demand due to its essential role in healthcare.
  • Supply Chain Issues: Recent recalls and manufacturing problems have affected the supply chain.
  • Regulatory Compliance: Adhering to FDA guidelines is critical for product safety and quality.
  • Competitive Market: The market is competitive, with multiple manufacturers competing for market share.
  • Global Opportunities: There are opportunities for growth in global markets and through innovation.

FAQs

  1. What is Broncho Saline used for? Broncho Saline, or 0.9% sodium chloride solution, is used for hydration, as an intravenous fluid, and for flushing intravenous lines.

  2. Why have there been recalls of Broncho Saline products? Recalls have been issued due to potential particulate matter, fluid leakage, and non-sterility concerns.

  3. How does the COVID-19 pandemic affect the demand for Broncho Saline? The pandemic has increased the demand for IV fluids and saline solutions, highlighting the importance of a robust supply chain.

  4. Who are the major manufacturers of Broncho Saline? Major manufacturers include B. Braun Medical Inc., Medline Industries, and HF Acquisition Co LLC.

  5. What are the key challenges facing the market for Broncho Saline? Key challenges include supply chain disruptions, regulatory compliance, and maintaining high-quality standards.

Sources

  1. Drugs.com: Broncho Saline FDA Alerts, Recalls & Warnings.
  2. Olympus Global: Integrated Report 2021.
  3. FDA: Center for Drug Evaluation and Research.
  4. DrugBank: Sodium chloride: Uses, Interactions, Mechanism of Action.

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