VANCOMYCIN Drug Patent Profile

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

Vancomycin is a drug marketed by Xellia Pharms Aps, Fresenius Kabi Usa, Lupin Ltd, Orient Pharma Co Ltd, Pai Holdings Pharm, Strides Pharma, Watson Labs, Alkem Labs Ltd, Amneal, Aspiro, Avet Lifesciences, Eugia Pharma, Gland Pharma Ltd, Hikma, Hikma Pharms, Hospira, Hospira Inc, Knack, Medimetriks Pharms, Meitheal, Mylan Labs Ltd, Sagent Pharms, Sandoz, Sandoz Inc, Slate Run Pharma, Teva Pharms Usa, Zhejiang Novus Pharm, Samson Medcl, and Baxter Hlthcare. and is included in fifty-four NDAs. There are six patents protecting this drug.

This drug has forty-seven patent family members in twenty-nine countries.

The generic ingredient in VANCOMYCIN 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

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

Summary for VANCOMYCIN

International Patents:	47
US Patents:	5
Applicants:	29
NDAs:	54
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	429
Patent Applications:	2,366
Drug Prices:	Drug price information for VANCOMYCIN
What excipients (inactive ingredients) are in VANCOMYCIN?	VANCOMYCIN excipients list
DailyMed Link:	VANCOMYCIN at DailyMed

See drug prices for VANCOMYCIN

See drug sales revenues for VANCOMYCIN

Recent Clinical Trials for VANCOMYCIN

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

Sponsor	Phase
Chang Gung Memorial Hospital	N/A
Hospital Universitario Evangelico de Curitiba	Phase 3
University of Duhok	N/A

See all VANCOMYCIN clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VANCOMYCIN

A07AA	Antibiotics
A07A	INTESTINAL ANTIINFECTIVES
A07	ANTIDIARRHEALS, INTESTINAL ANTIINFLAMMATORY/ANTIINFECTIVE AGENTS
A	Alimentary tract and metabolism

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AA	Antibiotics
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for VANCOMYCIN

VANCOMYCIN is protected by five US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan Labs Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	091554-001	Sep 19, 2011	AP	RX	No	Yes
Mylan Labs Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	POWDER;INTRAVENOUS	209481-006	Jun 26, 2024		RX	Yes	Yes
Hikma	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	203300-002	Aug 11, 2020	AP	RX	No	No
Fresenius Kabi Usa	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	062663-003	Jun 3, 1988	AP	RX	No	Yes

International Patents for VANCOMYCIN

See the table below for patents covering VANCOMYCIN around the world.

Country	Patent Number	Title	Estimated Expiration
Costa Rica	20170234	COMPOSICIONES DE ANTIBIÓTICO
Singapore	11201703568W	GLYCOPEPTIDE COMPOSITIONS
Croatia	P20200101
Tunisia	2017000182	GLYCOPEPTIDE COMPOSITIONS

VANCOMYCIN Market Analysis and Financial Projection Experimental

Vancomycin Market Dynamics and Financial Trajectory

Global Market Overview

The global vancomycin market is poised for significant growth over the coming years, driven by several key factors. As of 2020, the market was valued at approximately 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[1][2].

Market Drivers

Several factors are driving the growth of the vancomycin market:

• Rising Prevalence of Infectious Diseases: The increasing incidence of healthcare-associated infections, particularly those caused by methicillin-resistant Staphylococcus aureus (MRSA), is a major driver. Vancomycin is a critical antibiotic in treating these infections[1][4].
• Improvement in Diagnostic Techniques: Enhanced diagnostic methods are facilitating early detection and treatment of infections, thereby increasing the demand for vancomycin[4].
• Collaborations and Strategic Partnerships: The pharmaceutical industry is witnessing increased collaborations and strategic partnerships, which are enhancing the supply and development of vancomycin[4].

Regional Insights

North America

North America, particularly the United States, is expected to hold a significant share of the global vancomycin market. The U.S. market was valued at US$ 84.5 million in 2020 and is anticipated to grow at the highest CAGR during the forecast period. This growth is attributed to the rising consumer healthcare spending, early adoption of innovative treatments, and the presence of prominent manufacturers and advanced healthcare facilities[1].

China

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

Other Regions

Other notable regions include Japan and Canada, which are forecast to grow at 1.5% and 2.9% CAGR, respectively. Europe, led by Germany, is also expected to see growth, albeit at a more moderate rate[2].

Segment-wise Analysis

Linezolid Segment

The linezolid segment, which belongs to the oxazolidinones class of antibacterials, is expected to occupy a significant share of the global vancomycin market. Linezolid's broad spectrum of activity against gram-positive bacteria and its use in treating infections such as pneumonia and skin diseases are key factors driving this segment[1].

Application Segments

Vancomycin is used in various applications, including antibacterial treatments, dialysis care, and surgical prophylaxis. The lung infection segment, for instance, is projected to record a 5.1% CAGR and reach US$ 168.2 million by the end of the analysis period[2].

Challenges and Restraints

Despite the positive outlook, the vancomycin market faces several challenges:

• Nephrotoxicity and Ototoxicity: High doses of vancomycin can lead to nephrotoxicity and ototoxicity, which are significant concerns[4].
• Emergence of Vancomycin-Resistant Enterococci (VRE): The rise of VRE poses a threat to the effectiveness of vancomycin and could hinder market expansion[4].
• Regulatory Hurdles and Competition: Evolving regulations and competition from newer antibiotics also pose challenges to the market[4].

Market Opportunities

There are several opportunities for growth and innovation in the vancomycin market:

• Novel Formulations: Developing oral or extended-release versions of vancomycin could enhance patient compliance and reduce hospitalization costs[4].
• Combination Therapies: Partnerships for the development of combination therapies to enhance vancomycin's effectiveness are promising[4].
• Technological Advancements: Integrating artificial intelligence to predict resistance patterns and adopting personalized medicine approaches could offer significant growth avenues[4].

Financial Projections

• Global Market Size: The global vancomycin market is expected to reach US$ 465.1 million by 2027, growing at a CAGR of 5.8% from 2021 to 2027[1].
• China Market: The Chinese market is projected to reach US$ 102.3 million by 2027, with a CAGR of 9.4% during the same period[1].
• U.S. Market: The U.S. market was valued at US$ 84.5 million in 2020 and is expected to grow at the highest CAGR during the forecast period[1].

Key Players

The market is dominated by several key players, including:

• Alvogen
• MGB Biopharma Limited
• Oragenics
• Aphios Corporation
• Microbiotix[1].

Key Takeaways

• The global vancomycin market is projected to grow significantly, driven by the rising prevalence of infectious diseases and improvements in diagnostic techniques.
• North America and China are expected to be key regions driving market growth.
• The linezolid segment is anticipated to occupy a significant share due to its broad spectrum of activity.
• Challenges such as nephrotoxicity, ototoxicity, and the emergence of VRE need to be addressed through innovation and strategic partnerships.
• Opportunities in novel formulations, combination therapies, and technological advancements are expected to drive future growth.

FAQs

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[1].

What is the CAGR of the global vancomycin market from 2021 to 2027?

The global vancomycin market is projected to grow at a CAGR of 5.8% from 2021 to 2027[1].

Which region is expected to grow at the highest CAGR in the vancomycin market?

China is expected to grow at a CAGR of 9.4% from 2021 to 2027, making it one of the fastest-growing regions in the vancomycin market[1].

What are the key challenges faced by the vancomycin market?

Key challenges include nephrotoxicity and ototoxicity associated with high doses, the emergence of vancomycin-resistant enterococci (VRE), and regulatory hurdles and competition from newer antibiotics[4].

Who are the key suppliers of vancomycin?

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

Cited Sources

1. Fact.MR: Vancomycin Market Size, Share Global Trajectory - 2027[1].
2. PR Newswire: Global Vancomycin Strategic Business Report 2022: A Market Valued at $480.6 Million by 2027[2].
3. Market Research Intellect: Global Vancomycin Hydrochloride For Injection Market Size, Scope[3].
4. 360 Research Reports: Vancomycin Market Size & Share 2025-2030[4].