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Last Updated: October 15, 2019

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Donepezil hydrochloride - Generic Drug Details

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What are the generic drug sources for donepezil hydrochloride and what is the scope of patent protection?

Donepezil hydrochloride is the generic ingredient in five branded drugs marketed by Eisai Inc, Heritage Pharma, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sandoz, Sun Pharm Industries, Unichem Labs Ltd, Zydus Pharms Usa Inc, Accord Hlthcare, Aci Healthcare Ltd, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila, Cadila Pharms Ltd, Cipla Ltd, Cspc Ouyi, Dexcel Pharma, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Mylan, Mylan Pharms Inc, Osmotica Pharm Us, Par Pharm, Pliva Hrvatska Doo, Prinston Inc, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, Zydus Pharms, Amneal Pharms, and Allergan Sales Llc, and is included in fifty-three NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Donepezil hydrochloride has thirty-six patent family members in fifteen countries.

There are thirty-two drug master file entries for donepezil hydrochloride. Fifty-two suppliers are listed for this compound. There is one tentative approval for this compound.

Recent Clinical Trials for donepezil hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Phase 1
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPhase 2
Shanghai Mental Health CenterN/A

See all donepezil hydrochloride clinical trials

Recent Litigation for donepezil hydrochloride

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Apotex Inc.2008-12-17
EISAI CO., LTD. v. TEVA PHARMACEUTICALS USA, INC.2005-12-07
EISAI CO., LTD. v. MUTUAL PHARMACEUTICALS CO., INC.

See all donepezil hydrochloride litigation

Generic filers with tentative approvals for DONEPEZIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
  See Pricing  See Pricing10MGTABLET; ORAL
  See Pricing  See Pricing5MGTABLET; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for donepezil hydrochloride
Synonyms for donepezil hydrochloride
(+-)-2-((1-Benzyl-4-piperidyl)methyl)-5,6-dimethoxy-1-indanone hydrochloride
(+-)-2,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride
1-Benzyl-4-((5,6-dimethoxy-1-indanon)-2-yl)methylpiperidine hcl
110119-84-1
119D841
120011-70-3
142057-77-0
1H-Inden-1-one, 2,3-dihydro-5,6-dimethoxy-2-((1-(phenylmethyl)-4-piperidinyl)methyl)-, hydrochloride
1H-Inden-1-one, 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-, hydrochloride
1H-Inden-1-one, 2,3-dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-, hydrochloride (1:1)
2-((1-Benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one hydrochloride
2-((1-benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1h-inden-1-one hydrochloride 120014-06-
2-(1-Benzyl-4-piperidylmethyl)-5,6-dimethoxy-1-indanone Hydrochloride
2-[(1-benzyl-4-piperidyl)methyl]-5,6-dimethoxy-indan-1-one hydrochloride
2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one hydrochloride
2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one hydrochloride
2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one;hydrochloride
2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxyindan-1-onhydrochlorid
2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride
4CA-0472
5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-2,3-dihydroinden-1-one hydrochloride
5,6-dimethoxy-2-[[1-(phenylmethyl)piperidin-4-yl]methyl]-2,3-dihydroinden-1-one hydrochloride
884740-09-4 (.H2O)
95509-EP2283811A1
95509-EP2305672A1
A804411
AB0012676
AB2000577
AC-913
AC1L1L1B
AC1Q3EOB
ACT02683
AK-49308
AKOS000277343
AKOS016340656
AN-15418
AN-33661
ANW-47800
Aricept
Aricept (TN)
Aricept D
Aricept Evess
Aricept ODT
BC209014
BCP02205
BCP24884
BNAG
BR-49308
C24H29NO3.HCl
C24H30ClNO3
CAS-120011-70-3
CCG-101043
CCG-213309
CHEBI:4696
CHEMBL1678
CPD000449292
CS-0863
CTK8B5160
D00670
D4099
Donepezil (Hydrochloride)
Donepezil HCl
Donepezil HCl (Aricept)
Donepezil hydrochloride (JP17/USAN)
Donepezil hydrochloride [USAN:USP]
Donepezil hydrochloride [USAN]
Donepezil Hydrochloride 1.0 mg/ml in Methanol (as free base)
donepezil hydrochloride hydrate
Donepezil hydrochloride monohydrate, >=98% (HPLC)
Donepezil hydrochloride,(S)
Donepezil, HCl
donepezil, hydrochloride
donepezilhcl
DSSTox_CID_26698
DSSTox_GSID_46698
DSSTox_RID_81832
DTXSID0046698
E 2020
E 2020 (pharmaceutical)
E-2020
E2020
EBD893816
Eranz
FC0007
FT-0602354
FT-0625589
HY-B0034
I06-0342
KB-164081
KS-00000IPJ
KS-1051
LS-81820
Memac
Memorit
MFCD00881312 (97%)
MLS000758276
MLS001401387
MolPort-003-666-560
NC00293
NCGC00167537-01
NCGC00167537-02
NSC-737535
NSC-758882
NSC737535
NSC758882
Petrolite E 2020
Pharmakon1600-01504403
PubChem17962
Q-100096
Q-201040
RT-012410
S-5656
s2462
SAM001246627
SAM001247029
SC-19033
SC-69061
SCHEMBL1815
SMR000449292
ST2403759
SY110146
TL8000530
Tox21_112534
Tox21_112534_1
XWAIAVWHZJNZQQ-UHFFFAOYSA-N

US Patents and Regulatory Information for donepezil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No   See Pricing   See Pricing   See Pricing
Alembic Pharms Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201724-002 Feb 25, 2013 AB RX No No   See Pricing   See Pricing   See Pricing
Mylan DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202656-001 Oct 22, 2015 AB RX No No   See Pricing   See Pricing   See Pricing
Allergan Sales Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No   See Pricing   See Pricing   See Pricing
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004 DISCN Yes No   See Pricing   See Pricing   See Pricing
Dr Reddys DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202723-001 Jul 24, 2013 AB RX No No   See Pricing   See Pricing   See Pricing
Osmotica Pharm Us DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203114-001 Jan 26, 2016 DISCN No No   See Pricing   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for donepezil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996   See Pricing   See Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 022568-001 Jul 23, 2010   See Pricing   See Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996   See Pricing   See Pricing
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004   See Pricing   See Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996   See Pricing   See Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996   See Pricing   See Pricing
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996   See Pricing   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for donepezil hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 2/1998 Austria   See Pricing PRODUCT NAME: DONEPEZIL UND SEINE PHARMAKOLOGISCH ANNEHMBAREN SALZE, INSBESONDERE DONEPEZIL HYDROCHLORID; NAT. REGISTRATION NO/DATE: 1-22056, 1-22057 19970728; FIRST REGISTRATION: GB PL105550006, PL105550007 19970214
0296560 SPC/GB97/023 United Kingdom   See Pricing PRODUCT NAME: DONEPEZIL, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, INCLUDING THE HYDROCHLORIDE; REGISTERED: UK PL 10555/0006 19970214; UK PL 10555/0007 19970214
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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McKinsey
Harvard Business School
Mallinckrodt
Boehringer Ingelheim
Colorcon

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