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Last Updated: December 26, 2024

STERILE WATER Drug Patent Profile


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When do Sterile Water patents expire, and what generic alternatives are available?

Sterile Water is a drug marketed by Baxter Hlthcare, Am Regent, Fresenius Kabi Usa, Hikma, Hospira, Medefil Inc, Nephron, Nexus, B Braun, Icu Medical Inc, Taro, and Miles. and is included in twenty-two NDAs.

The generic ingredient in STERILE WATER 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

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

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US Patents and Regulatory Information for STERILE WATER

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 FOR INJECTION IN PLASTIC CONTAINER sterile water for injection LIQUID;N/A 018233-001 Approved Prior to Jan 1, 1982 AP RX Yes Yes ⤷  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 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 sterile water for irrigation LIQUID;IRRIGATION 017428-001 Approved Prior to Jan 1, 1982 AT RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Medefil Inc STERILE WATER FOR INJECTION sterile water for injection LIQUID;N/A 211188-004 Dec 2, 2019 AP RX No Yes ⤷  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 Market Analysis and Financial Projection Experimental

Sterile Water for Injection: Market Dynamics and Financial Trajectory

Introduction

Sterile Water for Injection is a critical component in the pharmaceutical industry, primarily used for reconstituting medications available as lyophilized powders. This article delves into the market dynamics, financial trajectory, and key factors influencing the Sterile Water for Injection market.

Market Size and Growth Projections

The global Sterile Water for Injection With Drugs Market has been experiencing significant growth. As of 2023, the market was valued at US$ 1385 million and is anticipated to reach US$ 2321.5 million by 2030, with a Compound Annual Growth Rate (CAGR) of 8.3% during the forecast period of 2024-2030[4].

Market Segmentation

The market is segmented based on several key factors:

Type

The market is segmented into vials and ampoules, and pre-filled syringes. These formats cater to different needs in the pharmaceutical industry, with vials and ampoules being more traditional and pre-filled syringes offering convenience and reduced risk of contamination[1][4].

Application

The applications include vaccines, biological products, and bio-pharmaceuticals. These segments are driven by the increasing demand for parenteral drugs and the need for sterile water in reconstituting these medications[1][4].

Geographical Regions

The market is analyzed across various geographical regions, including North America, Europe, Asia-Pacific, South America, and the Middle-East and Africa. North America has been a significant contributor to the market, driven by advanced healthcare infrastructure and high demand for pharmaceutical products[1][4].

Market Drivers

Several factors are driving the growth of the Sterile Water for Injection market:

Rising Prevalence of Chronic and Acute Illnesses

The increasing prevalence of chronic and acute illnesses has led to a higher demand for pharmaceutical drugs, many of which require sterile water for reconstitution[3].

Pharmaceutical Research & Development

Increased focus on pharmaceutical research and development, particularly in novel drug discovery and the formulation of liquid pharmaceutical drugs, has boosted the demand for sterile water[3].

Government Investments

Government investments in the life sciences industry have also contributed to the growth of the market by supporting the development and production of sterile water and other pharmaceutical products[3].

Market Restraints and Challenges

Despite the growth, the market faces several challenges:

Manufacturing Delays and Shortages

Manufacturing delays and shortages, as seen with major manufacturers like Pfizer and Fresenius Kabi, can significantly impact market supply and demand. These shortages often lead to increased demand for alternative products, such as sterile water bags, but can also result in healthcare personnel having to make difficult decisions about using non-recommended sterile liquids[2].

Dependence on Few Manufacturers

The market's reliance on a few major manufacturers can exacerbate the impact of any production issues, leading to broader market disruptions[2].

Key Players

The Sterile Water for Injection With Drugs Market is dominated by several key players:

  • Baxter Corporation
  • Hospira (ICU Medical)
  • Vetter
  • Otsuka
  • ROVI
  • Fresenius Kabi
  • Shijiazhuang No. 4 Pharmaceutical
  • Hikma
  • Kelun
  • Deo Gratias Parenteral[4].

These companies play a crucial role in meeting the global demand for sterile water and are continuously innovating to improve production efficiency and product quality.

Clinical Use and Importance

Sterile Water for Injection is essential for diluting or dissolving drugs for intravenous, intramuscular, or subcutaneous injection. It is indicated only for use as a pharmaceutic aid, and its small volume is unlikely to affect fluid balance significantly, except in neonates or very small infants[5].

Regional Market Analysis

The market is geographically diverse, with different regions contributing significantly:

  • North America: Known for its advanced healthcare infrastructure, North America accounts for a substantial share of the market.
  • Europe: Europe also plays a significant role, driven by a strong pharmaceutical industry.
  • Asia-Pacific: This region is expected to grow rapidly due to increasing healthcare needs and investments in the life sciences sector[1][4].

Financial Outlook

The financial trajectory of the Sterile Water for Injection With Drugs Market is promising, with a projected CAGR of 8.3% from 2024 to 2030. The market's value is expected to nearly double from US$ 1385 million in 2023 to US$ 2321.5 million by 2030[4].

Conclusion

The Sterile Water for Injection With Drugs Market is poised for significant growth, driven by increasing demand for pharmaceutical products, advancements in research and development, and government investments. Despite challenges such as manufacturing delays and shortages, the market's financial outlook is robust, with key players continuing to innovate and meet global demand.

Key Takeaways

  • The global Sterile Water for Injection With Drugs Market is projected to grow at a CAGR of 8.3% from 2024 to 2030.
  • The market is segmented by type (vials and ampoules, pre-filled syringes) and application (vaccines, biological products, bio-pharmaceuticals).
  • Key drivers include rising prevalence of chronic and acute illnesses, pharmaceutical R&D, and government investments.
  • Major manufacturers include Baxter Corporation, Hospira, Vetter, and Fresenius Kabi.
  • The market faces challenges such as manufacturing delays and shortages.

FAQs

Q: What is the primary use of Sterile Water for Injection?

A: Sterile Water for Injection is primarily used to reconstitute medications available as lyophilized powders for intravenous, intramuscular, or subcutaneous injection[2][5].

Q: Which regions are significant in the Sterile Water for Injection market?

A: North America, Europe, and the Asia-Pacific region are significant contributors to the market, driven by advanced healthcare infrastructure and increasing healthcare needs[1][4].

Q: What are the main challenges facing the Sterile Water for Injection market?

A: The main challenges include manufacturing delays and shortages, which can lead to market disruptions and the need for healthcare personnel to use alternative sterile liquids[2].

Q: Who are the key players in the Sterile Water for Injection market?

A: Key players include Baxter Corporation, Hospira (ICU Medical), Vetter, Otsuka, ROVI, Fresenius Kabi, and others[4].

Q: What is the projected market size of the Sterile Water for Injection With Drugs Market by 2030?

A: The market is projected to reach US$ 2321.5 million by 2030, growing at a CAGR of 8.3% from 2024 to 2030[4].

Sources

  1. Market Research Intellect: Global Sterile Water For Injection With Drugs Market Size, Scope ...
  2. ASHP: Sterile Water for Injection Shortages- FAQ
  3. BioSpace: Water-soluble Drugs Market Trends - Growing Use in Formulation of Liquid Pharmaceutical Drugs and Increased Focus on Developing Bioequivalent Drugs
  4. Valuates Reports: Sterile Water for Injection With Drugs Market Size
  5. Drugs.com: Sterile Water for Injection: Package Insert / Prescribing Info

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