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Last Updated: December 22, 2024

VANCOCIN HYDROCHLORIDE Drug Patent Profile


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Which patents cover Vancocin Hydrochloride, and what generic alternatives are available?

Vancocin Hydrochloride is a drug marketed by Ani Pharms and Steriscience Speclts and is included in six NDAs.

The generic ingredient in VANCOCIN HYDROCHLORIDE 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 Vancocin Hydrochloride

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

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Drug patent expirations by year for VANCOCIN HYDROCHLORIDE
Recent Clinical Trials for VANCOCIN HYDROCHLORIDE

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

SponsorPhase
National Institute of Allergy and Infectious Diseases (NIAID)Phase 4
Alexander FlanneryPhase 4
Memorial University of NewfoundlandPhase 3

See all VANCOCIN HYDROCHLORIDE clinical trials

Pharmacology for VANCOCIN HYDROCHLORIDE

US Patents and Regulatory Information for VANCOCIN HYDROCHLORIDE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Ani Pharms VANCOCIN HYDROCHLORIDE vancomycin hydrochloride CAPSULE;ORAL 050606-001 Apr 15, 1986 AB RX Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Steriscience Speclts VANCOCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062716-002 Mar 13, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Ani Pharms VANCOCIN HYDROCHLORIDE vancomycin hydrochloride FOR SOLUTION;ORAL 061667-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Steriscience Speclts VANCOCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062716-001 Mar 13, 1987 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Steriscience Speclts VANCOCIN HYDROCHLORIDE vancomycin hydrochloride INJECTABLE;INJECTION 062812-002 Nov 17, 1987 DISCN 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

VANCOCIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Vancomycin Hydrochloride Market Dynamics and Financial Trajectory

Introduction to Vancomycin Hydrochloride

Vancomycin hydrochloride is a glycopeptide antibiotic used to treat severe bacterial infections, particularly those caused by methicillin-resistant Staphylococcus aureus (MRSA). It is administered in various forms, including injections and oral capsules, and plays a crucial role in the treatment of infections such as skin infections, sepsis, endocarditis, bone and joint infections, and meningitis.

Global Market Size and Growth

The global vancomycin market has been experiencing steady growth, driven by increasing demand for effective antibiotics. As of 2020, the global vancomycin market was valued at US$ 313.7 million and is projected to reach US$ 465.1 million by 2027, growing at a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period from 2021 to 2027[1].

Regional Market Insights

North America

North America is expected to hold a significant share of the global vancomycin market. The region's market growth is driven by the rising prevalence 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 anticipated to grow at the highest CAGR during the forecast period due to early adoption of innovative treatments and robust healthcare infrastructure[1].

China

China is another key market for vancomycin, projected to reach a valuation of US$ 102.3 million by 2027, growing at a CAGR of 9.4% from 2021 to 2027. The growth in China is attributed to a rising population, greater healthcare awareness, and government initiatives for infection control[1].

Market Drivers

Rising Prevalence of Infectious Diseases

The increasing prevalence of infectious diseases, particularly those resistant to other antibiotics, is a significant driver for the vancomycin market. The need for effective treatments against MRSA and other gram-positive bacterial infections is driving the demand for vancomycin hydrochloride[1][4].

Advancements in Antibiotic Formulations

Continuous advancements in antibiotic formulations, including the development of new delivery systems and combination therapies, are expanding the market opportunities for vancomycin hydrochloride. For instance, the FDA-approved FIRVANQ™ vancomycin oral solution kit by CutisPharma has improved patient access and reduced the burden on pharmacists[2][4].

Government and Regulatory Support

Favorable government policies and regulatory support for new drug approvals are also fueling market growth. Governments are increasingly focusing on infection control measures, which includes the promotion of effective antibiotics like vancomycin hydrochloride[4].

Market Restraints

Potential for Adverse Side Effects

One of the significant challenges facing the vancomycin hydrochloride market is the potential for adverse side effects. Patients may experience nephrotoxicity, ototoxicity, and other allergic reactions, which can limit the drug's use[4].

Stringent Regulatory Framework

The stringent regulatory framework for new antibiotic approvals poses another challenge. The process of obtaining regulatory approvals is complex and time-consuming, which can delay market entry for new vancomycin hydrochloride products[4].

Market Opportunities

Unmet Demand for Oral Dosage Forms

There is an unmet demand for oral dosage forms of vancomycin, particularly in regions where intravenous therapy is not feasible. This presents an opportunity for pharmaceutical companies to develop and market oral vancomycin hydrochloride capsules[4].

Emerging Markets in Asia-Pacific

Emerging markets in the Asia-Pacific region show promising growth potential for vancomycin hydrochloride. The growing healthcare awareness and increasing demand for effective antibiotics in these regions are expected to drive market expansion[4].

Competitive Landscape

The vancomycin hydrochloride market is competitive, with several key players involved. Companies such as Alvogen, MGB Biopharma Limited, Oragenics, Aphios Corporation, and Microbiotix are prominent suppliers of vancomycin. CutisPharma, acquired by NovaQuest Capital Management, is also a significant player with its FDA-approved FIRVANQ™ vancomycin oral solution kit[1][2].

Product Development and Innovation

The market is witnessing significant product development and innovation. For example, the introduction of unit-of-use kits like those offered by CutisPharma under the FIRST® Kit brand has simplified the compounding process for pharmacists and improved patient safety. Ongoing research and development efforts are focused on improving the efficacy and safety of vancomycin hydrochloride formulations[2][4].

Financial Trajectory

The financial trajectory of the vancomycin hydrochloride market is positive, with steady growth projected over the next few years. Here are some key financial highlights:

  • 2020 Market Value: US$ 313.7 million[1]
  • 2027 Projected Market Value: US$ 465.1 million[1]
  • CAGR (2021-2027): 5.8%[1]
  • U.S. Market Value (2020): US$ 84.5 million[1]
  • China Market Value (2027): US$ 102.3 million[1]

Key Takeaways

  • The global vancomycin hydrochloride market is growing due to the rising prevalence of infectious diseases and advancements in antibiotic formulations.
  • North America and China are key regions driving market growth.
  • The market faces challenges such as potential adverse side effects and a stringent regulatory framework.
  • Emerging markets in the Asia-Pacific region and unmet demand for oral dosage forms present significant opportunities.
  • The competitive landscape is dominated by several key players, with ongoing innovation in product development.

Frequently Asked Questions (FAQs)

1. What is the projected global market value of vancomycin hydrochloride by 2027?

The global vancomycin market is expected to reach US$ 465.1 million by 2027[1].

2. Which region is expected to lead the vancomycin hydrochloride market growth?

North America, particularly the U.S., is expected to lead the market growth due to rising VRSA infections and advanced healthcare infrastructure[1].

3. What are the key drivers of the vancomycin hydrochloride market?

Key drivers include the rising prevalence of infectious diseases, advancements in antibiotic formulations, and favorable government policies[1][4].

4. Which companies are major suppliers of vancomycin hydrochloride?

Key suppliers include Alvogen, MGB Biopharma Limited, Oragenics, Aphios Corporation, Microbiotix, and CutisPharma[1][2].

5. What are the potential challenges facing the vancomycin hydrochloride market?

Challenges include the potential for adverse side effects and a stringent regulatory framework for new antibiotic approvals[4].

Cited Sources:

  1. Fact.MR - Vancomycin Market Size, Share Global Trajectory - 2027
  2. NovaQuest - NovaQuest Capital Management Acquires CutisPharma, Inc.
  3. Market Research Intellect - Global Vancomycin Hydrochloride For Injection Market
  4. 360 Research Reports - Vancomycin Hydrochloride Capsules Market Size 2025-2030

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