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FDA Orange Book · active-ingredient family

Vancomycin hydrochloride

Vancomycin hydrochloride is approved as 6 brand and 59 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VANCOMYCIN HYDROCHLORIDE · NDA 210274

6

Brand (NDA)

59

Generics (ANDA)

13

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, for solution, injectable, powder, solution

ProductApplicantApplicationTEApproved
VANCOMYCIN HYDROCHLORIDERLD×7ZHEJIANG NOVUS PHARMNDA 210274—Jan 20, 2023
TYZAVANRLD×7HIKMANDA 211962—Feb 15, 2019
VANCOMYCIN HYDROCHLORIDERLD×6MYLAN LABS LTDNDA 209481APJul 10, 2018
FIRVANQ KITRLD×2AZURITYNDA 208910AAJan 26, 2018
VANCOMYCIN HYDROCHLORIDE IN PLASTIC CONTAINERRLD×5BAXTER HLTHCARENDA 050671—Mar 01, 1999
VANCOCIN HYDROCHLORIDERLD×2ANI PHARMSNDA 050606ABApr 15, 1986

Generic (ANDA) products (59)

ProductApplicantApplicationTEApproved
VANCOMYCIN HYDROCHLORIDE×3STERISCIENCEANDA 215324APOct 02, 2025
VANCOMYCIN HYDROCHLORIDE×3GLANDANDA 218140APMar 21, 2025
VANCOMYCIN HYDROCHLORIDE×2EUGIA PHARMAANDA 217401APAug 04, 2023
VANCOMYCIN HYDROCHLORIDE×2HIKMAANDA 217489APJun 29, 2023
VANCOMYCIN HYDROCHLORIDEAMNEALANDA 215338—Jun 23, 2023
VANCOMYCIN HYDROCHLORIDE×2ALKEM LABS LTDANDA 214913AANov 14, 2022
VANCOMYCIN HYDROCHLORIDEMEITHEALANDA 215195APSep 15, 2022
VANCOMYCIN HYDROCHLORIDE×2MEITHEALANDA 215197APJul 28, 2022
VANCOMYCIN HYDROCHLORIDE×2MEITHEALANDA 215196APJul 27, 2022
VANCOMYCIN HYDROCHLORIDE×2ASPIROANDA 216591APJul 06, 2022
VANCOMYCIN HYDROCHLORIDE×3KNACKANDA 213059—Feb 15, 2022
VANCOMYCIN HYDROCHLORIDE×2SLATE RUN PHARMAANDA 215821APNov 18, 2021
VANCOMYCIN HYDROCHLORIDE×2HIKMAANDA 203300APAug 11, 2020
VANCOMYCIN HYDROCHLORIDE×2SLATE RUN PHARMAANDA 212332APJun 12, 2019
VANCOMYCIN HYDROCHLORIDE×2ORIENT PHARMA CO LTDANDA 210729ABApr 29, 2019
VANCOMYCIN HYDROCHLORIDE×2HIKMAANDA 204360APOct 15, 2018
VANCOMYCIN HYDROCHLORIDEHIKMA PHARMSANDA 206616APOct 03, 2018
VANCOMYCIN HYDROCHLORIDE×2EUGIA PHARMAANDA 205780APMar 31, 2016
VANCOMYCIN HYDROCHLORIDE×2EUGIA PHARMAANDA 205779APMar 29, 2016
VANCOMYCIN HYDROCHLORIDE×4GLANDANDA 205694APJan 21, 2016
VANCOMYCIN HYDROCHLORIDESAMSON MEDCLANDA 091532—Jan 06, 2016
VANCOMYCIN HYDROCHLORIDE×2HIKMAANDA 204107APDec 28, 2015
VANCOMYCIN HYDROCHLORIDE×2XELLIA PHARMS APSANDA 204125APDec 28, 2015
VANCOMYCIN HYDROCHLORIDE×2TEVA PHARMS USAANDA 201251—Dec 23, 2015
VANCOMYCIN HYDROCHLORIDE×2TEVA PHARMS USAANDA 201250—Dec 23, 2015
VANCOMYCIN HYDROCHLORIDE×2XELLIA PHARMS APSANDA 206243—Dec 23, 2015
VANCOMYCIN HYDROCHLORIDE×2XELLIA PHARMS APSANDA 091377—Sep 09, 2015
VANCOMYCIN HYDROCHLORIDE×2LUPINANDA 090439—Jan 28, 2015
VANCOMYCIN HYDROCHLORIDE×2AVET LIFESCIENCESANDA 202275—Oct 31, 2013
VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCESANDA 202274—Oct 31, 2013
VANCOMYCIN HYDROCHLORIDEAVET LIFESCIENCESANDA 202464—Oct 09, 2013
VANCOMYCIN HYDROCHLORIDE×2PLANO PHARMSANDA 201048—Aug 10, 2012
VANCOMYCIN HYDROCHLORIDE×2SAGENT PHARMSANDA 200837APAug 10, 2012
VANCOMYCIN HYDROCHLORIDE×2FRESENIUS KABI USAANDA 065453—Jun 18, 2012
VANCOMYCIN HYDROCHLORIDE×2PAI HOLDINGSANDA 065478ABApr 09, 2012
VANCOMYCIN HYDROCHLORIDE×2STRIDES PHARMAANDA 065490ABApr 09, 2012
VANCOMYCIN HYDROCHLORIDE×2WATSON LABSANDA 065510—Apr 09, 2012
VANCOMYCIN HYDROCHLORIDEMYLAN LABS LTDANDA 091554APSep 19, 2011
VANCOMYCIN HYDROCHLORIDEMYLAN LABS LTDANDA 091469—Jul 01, 2011
VANCOMYCIN HYDROCHLORIDE×2PLANO PHARMSANDA 090250—Apr 27, 2010
VANCOMYCIN HYDROCHLORIDEHOSPIRA INCANDA 065455—Apr 29, 2009
VANCOMYCIN HYDROCHLORIDE×2MYLAN LABS LTDANDA 065397APDec 30, 2008
VANCOMYCIN HYDROCHLORIDEMYLAN LABS LTDANDA 065432APDec 30, 2008
VANCOMYCIN HYDROCHLORIDE×2EUROFARMAANDA 065401APJun 30, 2008
VANCOLED×2LEDERLEANDA 063321—Oct 15, 1993
VANCOMYCIN HYDROCHLORIDE×2HOSPIRAANDA 062933APOct 29, 1992
VANCOMYCIN HYDROCHLORIDEHOSPIRAANDA 062931APOct 29, 1992
VANCOMYCIN HYDROCHLORIDE×2HOSPIRAANDA 063076APDec 21, 1990
VANCOMYCIN HYDROCHLORIDE×3HOSPIRAANDA 062912APAug 04, 1988
VANCOMYCIN HYDROCHLORIDEHOSPIRAANDA 062911APAug 04, 1988
VANCOMYCIN HYDROCHLORIDE×2HIKMAANDA 062879—Aug 02, 1988
VANCOR×2PHARMACIA AND UPJOHNANDA 062956—Aug 01, 1988
VANCOLED×5HIKMAANDA 062682—Mar 30, 1988
VANCOCIN HYDROCHLORIDE×3STERISCIENCEANDA 062812—Nov 17, 1987
VANCOMYCIN HYDROCHLORIDE×5FRESENIUS KABI USAANDA 062663APJul 31, 1987
VANCOCIN HYDROCHLORIDE×2STERISCIENCEANDA 062716—Mar 13, 1987
VANCOCIN HYDROCHLORIDE×2STERISCIENCEANDA 060180—Mar 21, 1986
VANCOCIN HYDROCHLORIDE×2STERISCIENCEANDA 062476—Mar 21, 1986
VANCOCIN HYDROCHLORIDE×2ANI PHARMSANDA 061667—Jul 13, 1983

Listed patents (13)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
10959947Mar 13, 2035in 8 yr 10 mo
ProductU-3105
10959948Mar 13, 2035in 8 yr 10 mo
ProductU-3105
10959949Mar 13, 2035in 8 yr 10 mo
ProductU-3104
10688046Mar 13, 2035in 8 yr 10 mo
Product
10959946Mar 13, 2035in 8 yr 10 mo
Product
10493028Mar 13, 2035in 8 yr 10 mo
Product
11638692Mar 13, 2035in 8 yr 10 mo
Product
11517609Nov 06, 2035in 9 yr 6 mo
U-282
10039804Nov 06, 2035in 9 yr 6 mo
ProductU-282
10188697Nov 06, 2035in 9 yr 6 mo
ProductU-282
10849956Nov 06, 2035in 9 yr 6 mo
Product
12161690Nov 06, 2035in 9 yr 6 mo
Product
11628200Nov 06, 2035in 9 yr 6 mo
Product

Vancomycin hydrochloride — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

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