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Last Updated: December 22, 2024

STERILE WATER IN PLASTIC CONTAINER Drug Patent Profile


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

Sterile Water In Plastic Container is a drug marketed by B Braun, Baxter Hlthcare, Icu Medical Inc, and Miles. and is included in five NDAs.

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

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

A generic version of STERILE WATER IN PLASTIC CONTAINER was approved as sterile water for irrigation by FRESENIUS KABI USA on August 12th, 2024.

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

US Patents and Regulatory Information for STERILE WATER 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 IN PLASTIC CONTAINER sterile water for irrigation LIQUID;IRRIGATION 016734-001 Approved Prior to Jan 1, 1982 AT RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc STERILE WATER IN PLASTIC CONTAINER sterile water for irrigation LIQUID;IRRIGATION 018313-001 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare STERILE WATER IN PLASTIC CONTAINER sterile water for irrigation LIQUID;IRRIGATION 017866-001 Approved Prior to Jan 1, 1982 AT RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Icu Medical Inc STERILE WATER IN PLASTIC CONTAINER sterile water for irrigation LIQUID;IRRIGATION 017513-001 Approved Prior to Jan 1, 1982 AT 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 IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Sterile Water in Plastic Containers: Market Dynamics and Financial Trajectory

Introduction

Sterile water in plastic containers is a crucial component in the pharmaceutical and healthcare industries, particularly for intravenous administrations and the preparation of injectable drugs. This article delves into the market dynamics, financial trajectory, and key factors influencing the growth of this market.

Global Market Size and Growth

The market for sterile water in plastic containers is closely tied to the broader pharmaceutical and healthcare sectors. As of 2024, the global bacteriostatic water for injection market, which includes sterile water, is valued at USD 1.22 billion and is expected to reach USD 2.09 billion by 2031, growing at a CAGR of 8%[3].

Market Drivers

Several factors are driving the growth of the sterile water in plastic containers market:

Increasing Demand for Injectable Drugs

The rising demand for injectable drugs, due to their rapid absorption and higher bioavailability, is a significant driver. Injectable drugs bypass the hepatic first-pass metabolic process, making them more effective, which in turn increases the demand for sterile water used in their preparation and administration[3].

Growing Prevalence of Chronic Diseases

The increasing prevalence of chronic diseases and the subsequent rise in surgical procedures worldwide are boosting the demand for sterile injections. This trend is particularly pronounced in regions with well-established healthcare infrastructures, such as North America, and emerging markets like Asia Pacific and Latin America[3].

Expansion of Healthcare Infrastructure

The expansion of healthcare infrastructure in developing economies, along with increasing healthcare expenditures and medical tourism, is creating a large patient pool and driving the demand for sterile water and other pharmaceutical products[3].

Regional Market Dynamics

North America

North America currently dominates the market due to its well-established healthcare infrastructure and the high number of surgical procedures performed in the region. The U.S. is a key contributor, driven by the growing demand for injectable drugs and the presence of major pharmaceutical companies[3].

Asia Pacific

Asia Pacific is emerging as the fastest-growing market, driven by the expanding healthcare sector in countries like China and India. The region's growing medical tourism and increasing spending on healthcare are significant factors contributing to this growth[3].

Latin America

Latin America is also witnessing rapid growth, driven by increasing healthcare expenditures, the expansion of healthcare infrastructure, and the rising prevalence of chronic diseases. Regulatory improvements and the growth of biopharmaceutical manufacturing in the region are additional drivers[3].

Container Type and Material

Plastic Containers

Plastic containers, particularly those made from polyethylene and polypropylene, are gaining popularity due to their convenience, safety, and cost-effectiveness. Single-dose vials made of plastic are increasingly adopted due to their ease of use and reduced risk of contamination[4].

FDA Approval and Safety Standards

Plastic containers used for sterile water must be approved by the FDA for food contact to ensure safety. The use of polyethylene plastic, which is approved for food contact, is common in these containers. Ensuring that the containers are free from toxic substances and are properly labeled is crucial for safety[2].

Financial Trajectory

Market Value Forecast

The sterile vials market, which includes sterile water-filled vials, is projected to expand significantly. By 2031, the sterile vials market is expected to reach a value of US$ 12 billion, growing at a CAGR of approximately 8% from 2021 to 2031[4].

Revenue Streams

The revenue streams for sterile water in plastic containers are diverse, including sales to biopharmaceutical companies, clinical labs, compounding labs, and contract manufacturing organizations (CMOs). The increasing demand from these sectors is expected to drive revenue growth[4].

Challenges and Opportunities

Quality and Safety Issues

One of the significant challenges is ensuring the quality and safety of the containers. Issues such as breakage, cracks, and delamination in glass vials, and the potential for leaching from plastic containers, need to be addressed. Collaborations with high-quality machine suppliers and the development of new materials can help mitigate these issues[4].

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 necessary regulatory approvals and setting up local production and distribution capabilities to tap into these markets effectively[3].

Use Cases and Applications

Intravenous Administration

Sterile water in plastic containers is widely used for intravenous administration after the addition of drugs. It is a critical component in hospitals and clinical settings, ensuring the safe and effective delivery of medications[5].

Pharmaceutical Preparation

Sterile water is used in the preparation and handling of various pharmaceutical products, including biologic drugs. The expanding landscape of sophisticated biologic therapies is driving the demand for sterile water in these processes[3].

Storage and Handling

Storage Conditions

Proper storage conditions are essential to maintain the quality of sterile water. Containers should be stored in cool, dry locations away from strong odor products and petroleum-based substances to prevent contamination[2].

Labeling and Identification

Each container must be properly labeled with the date and method of disinfection used. This ensures that the contents are clearly identified and safe for use[2].

Key Takeaways

  • The global market for sterile water in plastic containers is driven by the increasing demand for injectable drugs and the expansion of healthcare infrastructure.
  • North America currently dominates the market, but Asia Pacific is expected to be the fastest-growing region.
  • Ensuring the quality and safety of containers is crucial, and addressing challenges such as breakage and leaching is essential.
  • Emerging markets offer significant growth opportunities for manufacturers.

FAQs

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

The sterile water for injection market is expected to grow at a CAGR of 8% from 2024 to 2031[3].

Which region is expected to be the fastest-growing market for sterile water in plastic containers?

Asia Pacific is expected to be the fastest-growing market for sterile water in plastic containers, driven by the expanding healthcare sector and increasing healthcare expenditures[3].

What are the key drivers of the sterile water in plastic containers market?

Key drivers include the increasing demand for injectable drugs, the growing prevalence of chronic diseases, and the expansion of healthcare infrastructure in developing economies[3].

What are the safety standards for plastic containers used for sterile water?

Plastic containers must be approved by the FDA for food contact and must be free from toxic substances. Proper labeling and storage conditions are also essential[2].

What are the primary applications of sterile water in plastic containers?

Sterile water in plastic containers is primarily used for intravenous administration and in the preparation and handling of pharmaceutical products, including biologic drugs[3][5].

Sources

  1. Fortune Business Insights - Plastic Containers Market Size, Share | Growth Report [2032].
  2. Utah Department of Environmental Quality - Home Water Storage for an Emergency.
  3. Coherent Market Insights - Bacteriostatic Water for Injection Market Size, Share, Report 2031.
  4. Transparency Market Research - Sterile Vials Market Survey Report 2031.
  5. DailyMed - Sterile Water for Injection, USP in VIAFLEX Plastic Container For.

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