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FDA Orange Book · active-ingredient family

Venlafaxine hydrochloride

Venlafaxine hydrochloride is approved as 3 brand and 46 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VENLAFAXINE HYDROCHLORIDE · NDA 022104

3

Brand (NDA)

46

Generics (ANDA)

0

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule, extended release, tablet, tablet, extended release

ProductApplicantApplicationTEApproved
VENLAFAXINE HYDROCHLORIDERLD×4OSMOTICA PHARM USNDA 022104ABMay 20, 2008
EFFEXOR XRRLD×4UPJOHNNDA 020699ABOct 20, 1997
EFFEXORRLD×6WYETH PHARMS INCNDA 020151—Dec 28, 1993

Generic (ANDA) products (46)

ProductApplicantApplicationTEApproved
VENLAFAXINE HYDROCHLORIDE×2ABON PHARMS LLCANDA 217841ABFeb 07, 2025
VENLAFAXINE HYDROCHLORIDE×4TORRENTANDA 218180—Jan 28, 2025
VENLAFAXINE HYDROCHLORIDE×3ALEMBICANDA 217767ABJun 06, 2024
VENLAFAXINE HYDROCHLORIDE×3GRANULESANDA 217390ABMay 18, 2023
VENLAFAXINE HYDROCHLORIDE×4AJANTA PHARMA LTDANDA 214691ABApr 12, 2023
VENLAFAXINE HYDROCHLORIDE×3NOSTRUM PHARMS LLCANDA 200430—Apr 04, 2023
VENLAFAXINE HYDROCHLORIDE×4UNIQUEANDA 216044ABNov 28, 2022
VENLAFAXINE HYDROCHLORIDE×4ZYDUS PHARMSANDA 215622ABAug 30, 2022
VENLAFAXINE HYDROCHLORIDE×2PHARMADAXANDA 214423—Jan 04, 2022
VENLAFAXINE HYDROCHLORIDE×3YICHANG HUMANWELLANDA 214654ABAug 06, 2021
VENLAFAXINE HYDROCHLORIDE×2SOMERSET THERAPS LLCANDA 214609ABJun 30, 2021
VENLAFAXINE HYDROCHLORIDE×4ALKEM LABS LTDANDA 214127ABJun 10, 2021
VENLAFAXINE HYDROCHLORIDEADAPTISANDA 213927—Jan 21, 2021
VENLAFAXINE HYDROCHLORIDE×4ASCENT PHARMS INCANDA 214419ABOct 21, 2020
VENLAFAXINE HYDROCHLORIDE×3INVENTIA HLTHCAREANDA 203332ABMar 12, 2020
VENLAFAXINE HYDROCHLORIDE×2DEXCELANDA 209193ABOct 31, 2019
VENLAFAXINE HYDROCHLORIDE×3CADILA PHARMS LTDANDA 211323ABAug 29, 2019
VENLAFAXINE HYDROCHLORIDE×3ANNORA PHARMAANDA 212277ABJul 08, 2019
VENLAFAXINE HYDROCHLORIDE×3PLATINUMANDA 201272ABNov 23, 2018
VENLAFAXINE HYDROCHLORIDE×5CADILA PHARMS LTDANDA 206250ABNov 21, 2018
VENLAFAXINE HYDROCHLORIDE×3MACLEODS PHARMS LTDANDA 204889ABOct 05, 2017
VENLAFAXINE HYDROCHLORIDE×2MPP PHARMAANDA 205468ABMar 24, 2017
VENLAFAXINE HYDROCHLORIDE×5YAOPHARMA CO LTDANDA 202036ABMay 28, 2015
VENLAFAXINE HYDROCHLORIDE×3ANCHEN PHARMSANDA 078087—Mar 16, 2012
VENLAFAXINE HYDROCHLORIDE×3ORBION PHARMSANDA 091123ABJul 11, 2011
VENLAFAXINE HYDROCHLORIDE×3PHARMOBEDIENTANDA 078789—Jun 01, 2011
VENLAFAXINE HYDROCHLORIDE×3TORRENTANDA 090899—Jun 01, 2011
VENLAFAXINE HYDROCHLORIDE×3DR REDDYS LABS LTDANDA 078421ABMay 06, 2011
VENLAFAXINE HYDROCHLORIDE×3VALEANT PHARMS NORTHANDA 090071—Apr 15, 2011
VENLAFAXINE HYDROCHLORIDE×3AUROBINDO PHARMA LTDANDA 200834ABApr 14, 2011
VENLAFAXINE HYDROCHLORIDE×3SCIEGEN PHARMSANDA 078865ABApr 14, 2011
VENLAFAXINE HYDROCHLORIDE×3ZYDUS PHARMS USA INCANDA 090174ABApr 14, 2011
VENLAFAXINE HYDROCHLORIDE×5ALEMBIC PHARMS LTDANDA 078932ABDec 14, 2010
VENLAFAXINE HYDROCHLORIDE×4SUN PHARMANDA 091272—Aug 18, 2010
VENLAFAXINE HYDROCHLORIDE×5PRINSTON INCANDA 090027—Aug 04, 2010
VENLAFAXINE HYDROCHLORIDE×3TEVAANDA 076565ABJun 28, 2010
VENLAFAXINE HYDROCHLORIDE×5AMNEAL PHARMSANDA 079098—May 11, 2010
VENLAFAXINE HYDROCHLORIDE×5AUROBINDO PHARMAANDA 090555ABApr 07, 2010
VENLAFAXINE HYDROCHLORIDE×5HERITAGEANDA 078554ABJan 09, 2009
VENLAFAXINE HYDROCHLORIDE×5CHARTWELL RXANDA 077515—Jun 13, 2008
VENLAFAXINE HYDROCHLORIDE×5DR REDDYS LABS LTDANDA 078301ABJun 13, 2008
VENLAFAXINE HYDROCHLORIDE×5PHARMOBEDIENTANDA 077166—Jun 13, 2008
VENLAFAXINE HYDROCHLORIDE×5PLIVA HRVATSKA DOOANDA 078517—Jun 13, 2008
VENLAFAXINE HYDROCHLORIDE×5SUN PHARM INDS INCANDA 078627ABJun 13, 2008
VENLAFAXINE HYDROCHLORIDE×5ZYDUS PHARMS USAANDA 077653ABJun 13, 2008
VENLAFAXINE HYDROCHLORIDE×5TEVAANDA 076690ABAug 03, 2006

Listed patents

No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.

Venlafaxine 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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