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FDA Orange Book · active-ingredient family

Memantine hydrochloride

Memantine hydrochloride is approved as 3 brand and 43 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:NAMENDA XR · NDA 022525

3

Brand (NDA)

43

Generics (ANDA)

2

Listed patents

0

Exclusivity periods

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

ProductApplicantApplicationTEApproved
NAMENDA XRRLD×4ABBVIENDA 022525—Jun 21, 2010
NAMENDARLDALLERGANNDA 021627—Apr 18, 2005
NAMENDARLD×2ABBVIENDA 021487—Oct 16, 2003

Generic (ANDA) products (43)

ProductApplicantApplicationTEApproved
MEMANTINE HYDROCHLORIDE×4MACLEODS PHARMS LTDANDA 206310ABAug 28, 2025
MEMANTINE HYDROCHLORIDE×4VITRUVIASANDA 213985ABOct 11, 2022
MEMANTINE HYDROCHLORIDE×2HETERO LABS LTD VANDA 204389ABSep 26, 2022
MEMANTINE HYDROCHLORIDE×4AUROBINDO PHARMA LTDANDA 214651ABAug 09, 2021
MEMANTINE HYDROCHLORIDE×4YICHANG HUMANWELLANDA 211100ABApr 02, 2021
MEMANTINE HYDROCHLORIDE×2PURACAP LABS BLUANDA 210587ABDec 11, 2020
MEMANTINE HYDROCHLORIDEMEDLEY PHARMSANDA 210319AAAug 31, 2020
MEMANTINE HYDROCHLORIDE×2YILINGANDA 212947ABApr 03, 2020
MEMANTINE HYDROCHLORIDE×4ANI PHARMSANDA 205365—Feb 28, 2020
MEMANTINE HYDROCHLORIDE×2HIKMAANDA 208173—Feb 28, 2020
MEMANTINE HYDROCHLORIDE×2CHARTWELLANDA 090244—Jul 11, 2018
MEMANTINE HYDROCHLORIDE×2RENATAANDA 209527ABMay 07, 2018
MEMANTINE HYDROCHLORIDEAPOTEXANDA 209955AAFeb 09, 2018
MEMANTINE HYDROCHLORIDE×4ZYDUS PHARMSANDA 203293ABAug 03, 2017
MEMANTINE HYDROCHLORIDE×2ZYDUS LIFESCIENCESANDA 090961ABJul 10, 2017
MEMANTINE HYDROCHLORIDE×4PH HEALTHANDA 205784—Jun 09, 2017
MEMANTINE HYDROCHLORIDE×2STRIDES PHARMAANDA 202350ABMay 23, 2017
MEMANTINE HYDROCHLORIDE×4APOTEXANDA 206135—Nov 22, 2016
MEMANTINE HYDROCHLORIDE×2LANNETT CO INCANDA 207236—Nov 10, 2016
MEMANTINE HYDROCHLORIDE×4AMNEAL PHARMSANDA 205825ABOct 12, 2016
MEMANTINE HYDROCHLORIDE×4LUPINANDA 206028ABSep 28, 2016
MEMANTINE HYDROCHLORIDE×4RISINGANDA 206032ABSep 28, 2016
MEMANTINE HYDROCHLORIDE×4SUN PHARMANDA 205905—Sep 28, 2016
MEMANTINE HYDROCHLORIDESCIEGEN PHARMSANDA 205446—Dec 07, 2015
MEMANTINE HYDROCHLORIDE×2AJANTA PHARMA LTDANDA 206528ABNov 30, 2015
MEMANTINE HYDROCHLORIDE×2PURACAP PHARM LLCANDA 206855ABNov 17, 2015
MEMANTINE HYDROCHLORIDECHARTWELL MOLECULARANDA 204033AAOct 13, 2015
MEMANTINE HYDROCHLORIDEMACLEODS PHARMS LTDANDA 202790AAOct 13, 2015
MEMANTINE HYDROCHLORIDE×2ALEMBICANDA 200891ABOct 13, 2015
MEMANTINE HYDROCHLORIDE×2AUROBINDO PHARMA LTDANDA 203175ABOct 13, 2015
MEMANTINE HYDROCHLORIDE×2JUBILANT GENERICSANDA 091585—Oct 13, 2015
MEMANTINE HYDROCHLORIDE×2MACLEODS PHARMS LTDANDA 202840ABOct 13, 2015
MEMANTINE HYDROCHLORIDE×2TORRENTANDA 200155—Oct 13, 2015
MEMANTINE HYDROCHLORIDE×2UNICHEMANDA 200022ABOct 13, 2015
MEMANTINE HYDROCHLORIDE×2POINTVIEW HLDINGSANDA 090073—Sep 04, 2015
MEMANTINE HYDROCHLORIDE×2UPSHER SMITH LABSANDA 090043ABJul 31, 2015
MEMANTINE HYDROCHLORIDE×2AMNEAL PHARMSANDA 090041ABApr 10, 2015
MEMANTINE HYDROCHLORIDE×2LUPINANDA 090051ABApr 10, 2015
MEMANTINE HYDROCHLORIDE×2RISINGANDA 079225—Jan 30, 2015
MEMANTINE HYDROCHLORIDE×2ORBION PHARMSANDA 090044—Mar 12, 2012
MEMANTINE HYDROCHLORIDE×2TEVA PHARMSANDA 090052—Oct 25, 2011
MEMANTINE HYDROCHLORIDE×2SUN PHARMANDA 090058ABMay 05, 2010
MEMANTINE HYDROCHLORIDE×2DR REDDYS LABS LTDANDA 090048ABApr 14, 2010

Listed patents (2)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8039009Mar 24, 2029in 2 yr 10 mo
U-539
8039009*PEDSep 24, 2029in 3 yr 4 mo

Memantine hydrochloride — frequently asked questions

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

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