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Last Updated: December 22, 2024

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER Drug Patent Profile


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When do Vancomycin Hydrochloride In Plastic Container patents expire, and what generic alternatives are available?

Vancomycin Hydrochloride In Plastic Container is a drug marketed by Samson Medcl and Baxter Hlthcare and is included in two NDAs.

The generic ingredient in VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Vancomycin Hydrochloride In Plastic Container

A generic version of VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER was approved as vancomycin hydrochloride by FRESENIUS KABI USA on March 17th, 1987.

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Summary for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Drug patent expirations by year for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER
Recent Clinical Trials for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

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

SponsorPhase
Chang Gung Memorial HospitalN/A
Hospital Universitario Evangelico de CuritibaPhase 3
University of DuhokN/A

See all VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER clinical trials

Pharmacology for VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER

US Patents and Regulatory Information for VANCOMYCIN HYDROCHLORIDE 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
Samson Medcl VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride POWDER;INTRAVENOUS 091532-001 Jan 6, 2016 RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride SOLUTION;INTRAVENOUS 050671-005 Jan 25, 2024 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride SOLUTION;INTRAVENOUS 050671-003 Mar 1, 1999 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride SOLUTION;INTRAVENOUS 050671-004 Jan 25, 2024 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride SOLUTION;INTRAVENOUS 050671-002 Dec 20, 2010 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Baxter Hlthcare VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER vancomycin hydrochloride SOLUTION;INTRAVENOUS 050671-001 Apr 29, 1993 RX Yes 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

VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINER Market Analysis and Financial Projection Experimental

Vancomycin Hydrochloride Market Dynamics and Financial Trajectory

Market Overview

Vancomycin hydrochloride, a potent glycopeptide antibiotic, is crucial in treating a range of infections caused by methicillin-resistant Staphylococcus aureus (MRSA), including skin infections, sepsis, endocarditis, bone and joint infections, and meningitis. Here’s a detailed look at the market dynamics and financial trajectory of vancomycin hydrochloride.

Global Market Size and Growth

The global vancomycin hydrochloride market is poised for significant growth. As of 2020, the market was valued at US$ 313.7 million, and it is expected to reach US$ 465.1 million by 2027, expanding at a Compound Annual Growth Rate (CAGR) of 5.8% from 2021 to 2027[2][4].

Regional Market Insights

North America

North America, particularly the U.S., is anticipated to hold a significant share of the global vancomycin market. The region's growth is driven by the rising incidence of vancomycin-resistant Staphylococcus aureus (VRSA) infections, increased R&D initiatives, and a well-developed healthcare sector. The U.S. vancomycin market, in particular, was valued at US$ 84.5 million in 2020 and is expected to rise at the highest CAGR over the forecast period due to early adoption of innovative treatments and robust healthcare infrastructure[2][4].

China

China is another key market, projected to reach a valuation of US$ 102.3 million by 2027, growing at a CAGR of 9.4% from 2021 to 2027. This growth is attributed to a rising population, increased healthcare awareness, and government initiatives for infection control[2][4].

Europe

In Europe, countries like Germany and Canada are also expected to contribute to the market growth. The developed healthcare sector and increased consumer awareness about various treatments for infectious illnesses are driving market growth in these regions[2].

Drivers of Market Growth

Rising Prevalence of Infectious Diseases

The increasing prevalence of infectious diseases, particularly those caused by MRSA, is a significant driver of the vancomycin hydrochloride market. As the incidence of these infections rises, so does the demand for effective treatments like vancomycin[4].

Increased R&D Initiatives

Enhanced research and development initiatives in the pharmaceutical sector are leading to the development of new and more effective formulations of vancomycin. This innovation is driving market growth by providing better treatment options for patients[2].

Government Initiatives

Government initiatives for infection control and public health campaigns are crucial for raising awareness and driving the adoption of vancomycin. These initiatives help in early-phase identification and treatment of infections, thereby boosting market demand[4].

Restraints and Challenges

Resistance and Side Effects

One of the major challenges facing the vancomycin hydrochloride market is the development of resistance to the antibiotic. Additionally, vancomycin can have side effects such as nephrotoxicity and ototoxicity, which may limit its use in certain patient populations[3].

Regulatory Hurdles

Regulatory approvals and compliance can be a significant challenge for manufacturers. Ensuring that vancomycin products meet stringent regulatory standards can be time-consuming and costly[3].

Competitive Landscape

The vancomycin hydrochloride market is competitive, with several key players investing in R&D and regulatory approvals. Companies such as Alvogen, MGB Biopharma Limited, Oragenics, Aphios Corporation, and Microbiotix are prominent in the market. These companies are focused on developing new formulations and expanding their market presence through strategic partnerships and innovations[4].

Cost and Pricing

The cost of vancomycin hydrochloride varies based on treatment plans, insurance coverage, and the specific pharmacy or healthcare provider. The pricing strategy is also influenced by the competitive landscape, with generic versions of the drug often being more affordable than branded versions[2].

Product Formulations

Vancomycin hydrochloride is available in various formulations, including intravenous solutions. For instance, Vancomycin Injection, USP in the GALAXY plastic container (PL 2040) is a frozen, iso-osmotic, sterile, nonpyrogenic premixed solution containing 500 mg or 1 g of vancomycin as vancomycin hydrochloride. This formulation is designed for intravenous use only and has specific storage and stability recommendations[3][5].

Clinical Pharmacology

In patients with normal kidney function, intravenous dosing of vancomycin produces specific plasma concentrations. For example, multiple intravenous dosing of 1 g of vancomycin infused over 60 minutes results in mean plasma concentrations of approximately 63 mcg/mL immediately after infusion. This pharmacokinetic profile is crucial for effective treatment and minimizing side effects[3].

Government Support and Awareness

Government support through awareness campaigns and infection control initiatives is vital for the growth of the vancomycin hydrochloride market. These efforts help in early detection and treatment of infections, thereby increasing the demand for vancomycin[4].

Market Outlook

Revenue Analysis

The revenue analysis from 2017 to 2020 shows a steady increase in the market value, with projections indicating continued growth from 2021 to 2027. The market's financial trajectory is positive, driven by increasing demand and innovative product developments[4].

Category-wise Insights

The demand for vancomycin is driven by its broad spectrum of activity against many gram-positive bacteria. Linezolid, another antibiotic, is also seeing increased demand, but vancomycin remains a cornerstone in the treatment of MRSA infections[4].

Key Takeaways

  • Global Market Growth: The global vancomycin market is expected to reach US$ 465.1 million by 2027, growing at a CAGR of 5.8%.
  • Regional Dominance: North America, particularly the U.S., and China are expected to be key markets.
  • Type and Application: Vancomycin hydrochloride is used in treating various infections, with linezolid also driving market demand.
  • Cost and Pricing: Costs vary based on treatment plans, insurance, and pharmacies.
  • Competitive Landscape: Key players are investing in R&D and regulatory approvals.
  • Government Initiatives: Awareness campaigns and government support are crucial for market growth.

FAQs

1. What is the projected global market size for vancomycin by 2027?

The global vancomycin market is expected to reach US$ 465.1 million by 2027[2][4].

2. Which region is expected to dominate the vancomycin market?

North America, particularly the U.S., is expected to hold a significant share of the global vancomycin market[2][4].

3. What drives the growth of the vancomycin hydrochloride market?

The growth is driven by the rising prevalence of infectious diseases, increased R&D initiatives, and government initiatives for infection control[4].

4. What are the common side effects of vancomycin hydrochloride?

Common side effects include nephrotoxicity and ototoxicity, which can limit its use in certain patient populations[3].

5. What is the significance of the GALAXY plastic container in vancomycin formulations?

The GALAXY plastic container is specially designed to maintain the stability and sterility of the vancomycin solution, ensuring it remains effective for intravenous use[3][5].


Sources:

  1. Market Research Intellect - Vancomycin Hydrochloride Market Size, Scope And Forecast Report
  2. DrugPatentWatch - Vancomycin hydrochloride - Generic Drug Details
  3. FDA - Vancomycin Injection, USP in GALAXY Plastic Container (PL 2040)
  4. Fact.MR - Vancomycin Market Size, Share Global Trajectory - 2027
  5. Health Canada - Vancomycin Injection USP in 5% Dextrose

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