Last Updated: November 8, 2026

VANCOMYCIN HYDROCHLORIDE - Generic Drug Details

Name: VANCOMYCIN HYDROCHLORIDE Generic Launch, Drug Patent, and Exclusivity Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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What are the generic sources for vancomycin hydrochloride and what is the scope of patent protection?

Vancomycin hydrochloride is the generic ingredient in seven branded drugs marketed by Ani Pharms, Fresenius Kabi Usa, Lupin, Orient Pharma Co Ltd, Pai Holdings, Strides Pharma, Watson Labs, Azurity, Lederle, Alkem Labs Ltd, Amneal, Aurobindo Pharma, Steriscience, Hikma, Aspiro, Avet Lifesciences, Eugia Pharma, Eurofarma, Gland, Hainan Poly, Hikma Pharms, Hospira, Hospira Inc, Knack, Meitheal, Mylan Labs Ltd, Plano Pharms, Sagent Pharms, Teva Pharms Usa, Xellia Pharms Aps, Pharmacia And Upjohn, Samson Medcl, Zhejiang Novus Pharm, and Baxter Hlthcare, and is included in sixty-six NDAs. There are thirteen patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Thirty-seven suppliers are listed for this compound.

Summary for VANCOMYCIN HYDROCHLORIDE

International Patents:	62
US Patents:	13
Tradenames:	7
Applicants:	33
NDAs:	65
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	481
Patent Applications:	1,526
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VANCOMYCIN HYDROCHLORIDE
What excipients (inactive ingredients) are in VANCOMYCIN HYDROCHLORIDE?	VANCOMYCIN HYDROCHLORIDE excipients list
DailyMed Link:	VANCOMYCIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for VANCOMYCIN HYDROCHLORIDE

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

Sponsor	Phase
McGill University Health Centre/Research Institute of the McGill University Health Centre	PHASE3
The Methodist Hospital Research Institute	NA
Nantes University Hospital	PHASE2

See all VANCOMYCIN HYDROCHLORIDE clinical trials

Pharmacology for VANCOMYCIN HYDROCHLORIDE

Drug Class	Glycopeptide Antibacterial

Medical Subject Heading (MeSH) Categories for VANCOMYCIN HYDROCHLORIDE

Anti-Bacterial Agents

Anatomical Therapeutic Chemical (ATC) Classes for VANCOMYCIN HYDROCHLORIDE

Paragraph IV (Patent) Challenges for VANCOMYCIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRVANQ KIT	For Oral Solution	vancomycin hydrochloride	25 mg/mL and 50 mg/mL	208910	1	2020-05-18

US Patents and Regulatory Information for VANCOMYCIN HYDROCHLORIDE

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	VANCOLED	vancomycin hydrochloride	INJECTABLE;INJECTION	062682-003	May 11, 1988		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Hospira	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	062912-003	Jul 10, 2020		RX	No	Yes	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AA	RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Hikma	TYZAVAN	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-004	Feb 15, 2019		RX	Yes	Yes	⤷ Start Trial	⤷ Start Trial	Y			⤷ Start Trial
Hikma	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	204107-001	Dec 28, 2015	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Steriscience	VANCOCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	062812-002	Nov 17, 1987		DISCN	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
Mylan Labs Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	065397-001	Dec 30, 2008	AP	RX	No	No	⤷ Start Trial	⤷ Start Trial				⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

International Patents for VANCOMYCIN HYDROCHLORIDE

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Country	Patent Number	Title	Estimated Expiration
Australia	2015341763		⤷ Start Trial
Brazil	112017009405		⤷ Start Trial
Canada	2964524		⤷ Start Trial
Chile	2017001139		⤷ Start Trial
China	107073072		⤷ Start Trial
Colombia	2017005391		⤷ Start Trial
Costa Rica	20170234		⤷ Start Trial
>Country	>Patent Number	>Title	>Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.