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FDA Orange Book · active-ingredient family

Donepezil hydrochloride

Donepezil hydrochloride is approved as 5 brand and 47 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:ADLARITY · NDA 212304

5

Brand (NDA)

47

Generics (ANDA)

12

Listed patents

0

Exclusivity periods

Brand (NDA) products · solution, system, tablet, tablet, orally disintegrating

ProductApplicantApplicationTEApproved
ADLARITYRLD×2CORIUMNDA 212304—Mar 11, 2022
ARICEPTRLDEISAI INCNDA 022568ABJul 23, 2010
ARICEPTRLDEISAI INCNDA 021719—Oct 18, 2004
ARICEPT ODTRLD×2EISAI INCNDA 021720—Oct 18, 2004
ARICEPTRLD×2EISAI INCNDA 020690ABNov 25, 1996

Generic (ANDA) products (47)

ProductApplicantApplicationTEApproved
DONEPEZIL HYDROCHLORIDE×2HISUN PHARM HANGZHOUANDA 205269ABJul 27, 2018
DONEPEZIL HYDROCHLORIDE×2CADILA PHARMS LTDANDA 204609ABSep 19, 2017
DONEPEZIL HYDROCHLORIDEZYDUS PHARMSANDA 203162ABAug 31, 2017
DONEPEZIL HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 202410—Mar 24, 2017
DONEPEZIL HYDROCHLORIDE×2UNICHEMANDA 204831—Nov 10, 2016
DONEPEZIL HYDROCHLORIDE×2UNICHEMANDA 203656—Jun 23, 2016
DONEPEZIL HYDROCHLORIDECHARTWELL RXANDA 203419—Apr 12, 2016
DONEPEZIL HYDROCHLORIDEDEXCELANDA 203713ABFeb 19, 2016
DONEPEZIL HYDROCHLORIDEOSMOTICA PHARM USANDA 203114—Jan 26, 2016
DONEPEZIL HYDROCHLORIDEACTAVIS ELIZABETHANDA 202415—Dec 17, 2015
DONEPEZIL HYDROCHLORIDELUPINANDA 202782—Oct 30, 2015
DONEPEZIL HYDROCHLORIDERISINGANDA 202656—Oct 22, 2015
DONEPEZIL HYDROCHLORIDESUN PHARMANDA 204293—Jun 05, 2015
DONEPEZIL HYDROCHLORIDE×2HETERO LABS LTD VANDA 203034ABJan 30, 2015
DONEPEZIL HYDROCHLORIDE×2SCIEGEN PHARMSANDA 203907ABOct 29, 2014
DONEPEZIL HYDROCHLORIDETWI PHARMSANDA 203104ABOct 29, 2014
DONEPEZIL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 202631ABJan 22, 2014
DONEPEZIL HYDROCHLORIDEDR REDDYSANDA 202723ABJul 24, 2013
DONEPEZIL HYDROCHLORIDEPH HEALTHANDA 202542—Jul 24, 2013
DONEPEZIL HYDROCHLORIDE×2RISINGANDA 202114ABJul 05, 2013
DONEPEZIL HYDROCHLORIDE×2ALEMBIC PHARMS LTDANDA 201724ABFeb 25, 2013
DONEPEZIL HYDROCHLORIDE×2MACLEODS PHARMS LTDANDA 201787ABDec 14, 2012
DONEPEZIL HYDROCHLORIDE×2ZYDUS LIFESCIENCESANDA 090100ABOct 24, 2012
DONEPEZIL HYDROCHLORIDE×2MACLEODS PHARMS LTDANDA 201146ABAug 17, 2012
DONEPEZIL HYDROCHLORIDE×2INDICUS PHARMAANDA 201634—Jun 13, 2012
DONEPEZIL HYDROCHLORIDE×2ACCORD HLTHCAREANDA 201335—Aug 29, 2011
DONEPEZIL HYDROCHLORIDE×2APOTEXANDA 078841—Jun 02, 2011
DONEPEZIL HYDROCHLORIDE×2AIPING PHARM INCANDA 090290—May 31, 2011
DONEPEZIL HYDROCHLORIDE×2AUROBINDOANDA 090056ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2CHARTWELL RXANDA 090425ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2CIPLA LTDANDA 077518ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2DR REDDYS LABS LTDANDA 201001ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2HERITAGE PHARMAANDA 077344—May 31, 2011
DONEPEZIL HYDROCHLORIDE×2HIKMA PHARMSANDA 090247—May 31, 2011
DONEPEZIL HYDROCHLORIDE×2JUBILANT GENERICSANDA 090768ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2NATCO PHARMAANDA 090521—May 31, 2011
DONEPEZIL HYDROCHLORIDE×2NOVITIUM PHARMAANDA 090551ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2PRINSTON INCANDA 200292ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2STRIDES PHARMAANDA 078662ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2SUN PHARM INDSANDA 090493—May 31, 2011
DONEPEZIL HYDROCHLORIDE×2TORRENT PHARMSANDA 090686ABMay 31, 2011
DONEPEZIL HYDROCHLORIDE×2WOCKHARDTANDA 091267—May 31, 2011
DONEPEZIL HYDROCHLORIDE×2AIPING PHARM INCANDA 091198—May 10, 2011
DONEPEZIL HYDROCHLORIDE×2ZYDUS PHARMS USA INCANDA 090175—May 10, 2011
DONEPEZIL HYDROCHLORIDE×2CHARTWELL RXANDA 078388—Nov 26, 2010
DONEPEZIL HYDROCHLORIDE×2SUN PHARM INDS LTDANDA 076786—Nov 26, 2010
DONEPEZIL HYDROCHLORIDE×2SUN PHARM INDUSTRIESANDA 077975—Dec 11, 2009

Listed patents (12)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
8481565Oct 04, 2026in 4 mo
Product
12161767Dec 30, 2036in 10 yr 8 mo
SubstanceProductU-3334
12168075Dec 30, 2036in 10 yr 8 mo
U-3334
11679086May 26, 2037in 11 yr 1 mo
U-3334
11103463Jul 26, 2037in 11 yr 3 mo
U-3334
10016372Jul 26, 2037in 11 yr 3 mo
U-3334
10300025Jul 26, 2037in 11 yr 3 mo
Product
10307379Jul 26, 2037in 11 yr 3 mo
Product
9993466Jul 26, 2037in 11 yr 3 mo
Product
11648214Sep 23, 2037in 11 yr 5 mo
ProductU-3334
10835499May 20, 2038in 12 yr 1 mo
ProductU-3334
10966936Aug 11, 2038in 12 yr 4 mo
ProductU-3334

Donepezil 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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