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Last Updated: December 27, 2024

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER Drug Patent Profile


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Which patents cover Sterile Water For Injection In Plastic Container, and when can generic versions of Sterile Water For Injection In Plastic Container launch?

Sterile Water For Injection In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, Fresenius Kabi Usa, Icu Medical Inc, and Taro. and is included in seven NDAs.

The generic ingredient in STERILE WATER FOR INJECTION IN PLASTIC CONTAINER is sterile water for injection. There are one thousand and seventy-two drug master file entries for this compound. Eighteen suppliers are listed for this compound. Additional details are available on the sterile water for injection profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sterile Water For Injection In Plastic Container

A generic version of STERILE WATER FOR INJECTION IN PLASTIC CONTAINER was approved as sterile water for injection by HOSPIRA on October 27th, 1982.

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Summary for STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
Drug patent expirations by year for STERILE WATER FOR INJECTION IN PLASTIC CONTAINER

US Patents and Regulatory Information for STERILE WATER FOR INJECTION 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 STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 019077-001 Mar 2, 1984 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 019869-001 Dec 26, 1989 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 018632-002 Apr 19, 1988 AP RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Taro STERILE WATER FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 077393-001 Aug 11, 2006 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

STERILE WATER FOR INJECTION IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sterile Water for Injection in Plastic Containers

Market Overview

The market for sterile water for injection, particularly in plastic containers, is experiencing significant growth driven by several key factors. This market is integral to the pharmaceutical and biopharmaceutical industries, where sterile water is essential for the preparation and administration of injectable drugs.

Market Size and Growth

The global bacteriostatic water for injection market is estimated to be valued at USD 1.22 billion in 2024 and is projected to reach USD 2.09 billion by 2031, growing at a compound annual growth rate (CAGR) of 8% from 2024 to 2031[1].

Key Drivers

Increasing Demand for Injectable Drugs

The rising demand for injectable drugs, due to their rapid absorption and higher bioavailability, is a major driver. Injectable drugs bypass the hepatic first-pass metabolic process, making them more effective. This demand is further fueled by the increasing number of biologic drugs in clinical pipelines and undergoing regulatory approvals[1].

Growing Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases globally is driving the need for more medical interventions, including surgeries and injectable treatments. This has led to a higher demand for sterile water for injection[1].

Expanding Healthcare Infrastructure

In regions like Asia Pacific, Latin America, and Eastern Europe, the expansion of healthcare infrastructure and increasing access to medical services are boosting the demand for sterile water for injection. Countries such as China, India, Japan, and South Korea are particularly significant due to their large patient pools and growing healthcare expenditures[1][2].

Market Segments

By Container Type

The market is segmented by container type, with single-dose vials and pre-filled syringes being prominent. Single-dose vials are gaining popularity due to their convenience and safety, reducing the risk of contamination and ensuring precise dosing[1][3].

By Application

Sterile water for injection is used in various applications, including vaccines, biological products, and biopharmaceuticals. The growing demand for these products, especially in the context of advanced therapy medicinal products (ATMPs), is driving market growth[3][4].

Geographical Analysis

North America

North America currently dominates the market due to its well-established healthcare infrastructure and high demand for sterile injections. The U.S. is a key market, with extensive demand for sterile water in the synthesis of biopharmaceuticals[1][4].

Asia Pacific

The Asia Pacific region is expected to be the fastest-growing market, driven by expanding healthcare sectors, rising medical tourism, and increasing healthcare spending in countries like China and India. Japan, China, and South Korea are also recovering from the impact of COVID-19, presenting opportunities for market growth[1].

Europe and Latin America

Europe offers lucrative opportunities due to new product launches and the adoption of minimally invasive surgeries. Latin America is also witnessing rapid growth due to increasing healthcare expenditures and the expansion of healthcare infrastructure[1][2].

Market Challenges

Strict Regulatory Requirements

The market is subject to stringent regulatory requirements, which can be a significant challenge. Manufacturers must obtain necessary regulatory approvals and comply with strict safety and sterility standards to operate in this market[1].

High Costs and Emerging Alternatives

High costs associated with healthcare services, particularly in low and middle-income countries, can hamper market growth. Additionally, the emergence of alternative infusion solutions could pose a threat to the traditional bacteriostatic water market[1].

Financial Trajectory

Revenue Projections

The global sterile water for injection market, including bacteriostatic water, is expected to see substantial revenue growth. The market size is projected to increase significantly over the forecast period, driven by the factors mentioned above[1][3].

Investment and R&D

Significant investments by pharmaceutical companies in improving water quality methods and expanding their product portfolios are expected to bolster market growth. The focus on advanced therapy medicinal products (ATMPs) and biopharmaceuticals will also drive R&D, leading to increased demand for sterile water for injection[1][4].

Key Players

The market is highly fragmented, with prominent players such as Merck KGaA, Baxter International, Inc., Johnson & Johnson Services, Inc., Abbott, Thermo Fisher Scientific, Pfizer Inc., Serum Institute of India, and Novartis. These companies are focusing on mergers and acquisitions, product portfolio expansion, and improving production methods to stay competitive[4].

Product Specifications

Sterile water for injection, such as that provided by Baxter Healthcare Corporation, is sterile, nonpyrogenic, and distilled. It is packaged in single-dose containers, such as VIAFLEX plastic containers, which are designed to ensure sterility and safety. The solution has a pH range of 5.0 to 7.0 and zero osmolarity, making it suitable for intravenous administration after the addition of suitable solutes[5].

Emerging Markets

Emerging markets in Asia Pacific, Latin America, Eastern Europe, the Middle East, and Africa present significant growth opportunities. Manufacturers should focus on obtaining regulatory approvals and setting up local production and distribution capabilities to tap into these markets efficiently[1].

Conclusion

The market for sterile water for injection in plastic containers is poised for significant growth, driven by increasing demand for injectable drugs, expanding healthcare infrastructure, and the growing prevalence of chronic diseases. While regulatory challenges and high costs are potential hurdles, the overall outlook is positive, with substantial revenue growth projected over the next several years.

Key Takeaways

  • The global bacteriostatic water for injection market is expected to grow from USD 1.22 billion in 2024 to USD 2.09 billion by 2031.
  • Increasing demand for injectable drugs and growing prevalence of chronic diseases are key drivers.
  • North America dominates the market, but Asia Pacific is expected to be the fastest-growing region.
  • Strict regulatory requirements and high costs are significant challenges.
  • Emerging markets offer substantial growth opportunities.

FAQs

What is the projected growth rate of the bacteriostatic water for injection market?

The bacteriostatic water for injection market is expected to grow at a CAGR of 8% from 2024 to 2031[1].

Which regions are expected to drive the growth of the sterile water for injection market?

North America currently dominates the market, but Asia Pacific is expected to be the fastest-growing region. Europe and Latin America also offer significant growth opportunities[1][2].

What are the key applications of sterile water for injection?

Sterile water for injection is used in the preparation of vaccines, biological products, and biopharmaceuticals. It is also used as a vehicle for suitable medications and in the aseptic preparation of parenteral solutions[3][5].

Who are the major players in the sterile water for injection market?

Major players include Merck KGaA, Baxter International, Inc., Johnson & Johnson Services, Inc., Abbott, Thermo Fisher Scientific, Pfizer Inc., Serum Institute of India, and Novartis[4].

What are the challenges faced by the sterile water for injection market?

The market faces challenges such as strict regulatory requirements, high costs associated with healthcare services, and the emergence of alternative infusion solutions[1].

Sources

  1. Coherent Market Insights: Bacteriostatic Water for Injection Market Size, Share, Report 2031.
  2. Entrepreneur India: How to start your own Sterile Water for Injection Production Business.
  3. Market Research Intellect: Global Sterile Water For Injection With Drugs Market Size, Scope.
  4. GlobeNewswire: Water for Injection Market to Exceed USD 53.8 Bn by 2031.
  5. DailyMed: Sterile Water for Injection, USP in VIAFLEX Plastic Container For Intravenous Use.

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