Vancomycin - Generic Drug Details

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What are the generic drug sources for vancomycin and what is the scope of freedom to operate?

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

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

There are twenty-two drug master file entries for vancomycin.

Summary for vancomycin

International Patents:	47
US Patents:	13
Tradenames:	7
Applicants:	34
NDAs:	64
Drug Master File Entries:	22
Raw Ingredient (Bulk) Api Vendors:	37
Clinical Trials:	429
Patent Applications:	7,073
Drug Prices:	Drug price trends for vancomycin
What excipients (inactive ingredients) are in vancomycin?	vancomycin excipients list
DailyMed Link:	vancomycin at DailyMed

See drug prices for vancomycin

Drug Sales Revenue Trends for vancomycin

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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

US Patents and Regulatory Information for vancomycin

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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
Mylan Labs Ltd	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	091469-001	Jul 1, 2011		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zhejiang Novus Pharm	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	POWDER;INTRAVENOUS, ORAL	210274-002	Jan 20, 2023		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Eugia Pharma	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	205780-001	Mar 31, 2016	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	VANCOLED	vancomycin hydrochloride	INJECTABLE;INJECTION	062682-004	May 11, 1988		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hikma	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	INJECTABLE;INJECTION	203300-002	Aug 11, 2020	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Xellia Pharms Aps	VANCOMYCIN HYDROCHLORIDE	vancomycin hydrochloride	SOLUTION;INTRAVENOUS	211962-005	May 13, 2020		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
>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

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Country	Patent Number	Title	Estimated Expiration
South Korea	20170078830	글리코펩티드 조성물 (GLYCOPEPTIDE COMPOSITIONS)	⤷ Sign Up
Saudi Arabia	517381446	تركيبات مضاد حيوي (ANTIBIOTIC COMPOSITIONS)	⤷ Sign Up
Spain	2769849		⤷ Sign Up
Philippines	12017500720	GLYCOPEPTIDE COMPOSITIONS	⤷ Sign Up
Denmark	3215173		⤷ Sign Up
Denmark	3542812		⤷ Sign Up
China	107073072	糖肽组合物 (Glycopeptide compositions)	⤷ Sign Up
>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. 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.