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ARICEPT Drug Profile

When do Aricept patents expire, and what generic alternatives are available?

Aricept is a drug marketed by Eisai Inc and is included in four NDAs. There is one patent protecting this drug and two Paragraph IV challenges.

The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Fifty-seven suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for ARICEPT

US Patents:	1
Applicants:	1
NDAs:	4
Suppliers / Packagers:	4
Bulk Api Vendors:	181
Clinical Trials:	128
Patent Applications:	4,100
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ARICEPT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARICEPT
DailyMed Link:	ARICEPT at DailyMed

Drug patent expirations by year for ARICEPT

Pharmacology for ARICEPT

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Synonyms for ARICEPT

(+-)-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
(+/-)-2-[(1-benzylpiperidin-4-yl)methyl]-5,6-dimethoxy-indan-1-one
(RS)-2-[(1-BENZYL-PIPERIDIN-4-YL)METHYL]-5,6-DIMETHOXYINDAN-1-ONE
014D064
1-Benzyl-4-((5,6-dimethoxy-1-indanon)-2-yl)methylpiperidine hcl
1-Benzyl-4-[(5,6-dimethoxy-1-oxoindan-2-yl)methyl]piperidine; Donepezil
110119-84-1
119D841
120011-70-3
120014-06-4
142057-77-0
142057-79-2
1H-Inden-1-one, 2,3-dihydro-5,6-dimethoxy-2-((1-(phenylmethyl)-4-piperidinyl)methyl)-
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
2-((1-Benzylpiperidin-4-yl)methyl)-5,6-dimethoxy-2,3-dihydro-1H-inden-1-one
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-piperidin-4-ylmethyl)-5,6-dimethoxy-indan-1-one hydrochloride
2-[(1-benzyl-4-piperidyl)methyl]- 5,6-dimethoxy-2,3-dihydroinden-1-one
2-[(1-benzyl-4-piperidyl)methyl]-5,6-dimethoxy-2,3-dihydroinden-1-one
2-[(1-benzyl-4-piperidyl)methyl]-5,6-dimethoxy-indan-1-one
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
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
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-one
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
2,3-dihydro-5,6-dimethoxy-2 [[1-(phenyl methyl)-4-piperidinyl]methyl]-1H-inden-1-one
2,3-Dihydro-5,6-dimethoxy-2-[[1-(phenylmethyl)-4-piperidinyl]methyl]-1H-inden-1-one hydrochloride
2,3-dihydro-5,6-dimethoxy-2[[1-(phenyl methyl)-4-piperidinyl]methyl]-1H-inden-1-one
32288-EP2269989A1
32288-EP2269990A1
32288-EP2275420A1
32288-EP2278970A1
32288-EP2280010A2
32288-EP2281815A1
32288-EP2283811A1
32288-EP2289882A1
32288-EP2289886A1
32288-EP2295417A1
32288-EP2298758A1
32288-EP2298759A1
32288-EP2298761A1
32288-EP2298772A1
32288-EP2298776A1
32288-EP2301933A1
32288-EP2305640A2
32288-EP2305664A1
32288-EP2305675A1
32288-EP2308839A1
32288-EP2311823A1
32288-EP2311827A1
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
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
AB0013927
AB00640013_09
AB00640013_10
AB00640013-07
AB00640013-08
AB1004836
AB2000577
AC-6969
AC-913
AC1L1FAE
AC1L1L1B
AC1Q3EOB
ACT02683
ADEBPBSSDYVVLD-UHFFFAOYSA-N
AK-49308
AK-72906
AKOS000277311
AKOS000277343
AKOS016340656
AN-15418
AN-33661
AN-9524
ANW-47800
Aricept (TN)
Aricept D
Aricept Evess
Aricept ODT
BC204600
BC209014
BCP9000622
BCPP000253
BDBM8960
BNAG
BR-49308
BR-72906
C24H29NO3
C24H29NO3.HCl
C24H30ClNO3
CAS-120011-70-3
CCG-101043
CCG-213309
CHEBI:4696
CHEBI:53289
CHEMBL1678
CHEMBL502
CPD000449292
CS-0863
CS-2866
CTK4C2920
CTK8B5160
D00670
D07869
D0NS6H
D4099
DB00843
Domepezil
Donaz (TN)
donepezil
Donepezil (Hydrochloride)
Donepezil (INN)
Donepezil (transdermal patch, Alzheimer's disease)
Donepezil [INN:BAN]
Donepezil HCl
Donepezil HCl (Aricept)
Donepezil hydrochloride
Donepezil hydrochloride (JP17/USAN)
Donepezil hydrochloride [USAN]
Donepezil Hydrochloride 1.0 mg/ml in Methanol (as free base)
donepezil hydrochloride hydrate
donepezil, hydrochloride
donepezilhcl
donepezilium oxalate
donepezilium oxalate trihydrate
donepezilo
donepezilum
donezpil
donezpil HCl
donezpil hydrochloride
DR002140
DSSTox_CID_26698
DSSTox_GSID_46698
DSSTox_RID_81832
DTXSID0046698
DTXSID8048317
E 2020
E 2020 (pharmaceutical)
E-2020
E2020
EBD50998
EBD893816
Eranz
FC0007
FT-0601545
FT-0602354
FT-0625589
GTPL6599
HE185226
HE185227
HE295056
HSDB 7743
HY-14566
HY-B0034
I06-0342
I06-0343
I903
KB-164081
KB-67912
KBio2_002144
KBio2_004712
KBio2_007280
KBioSS_002144
KS-00000IPJ
KS-00000KZG
KS-1051
LS-81819
LS-81820
Memac
Memorit
MFCD00881312
MFCD00912833
MLS000758276
MLS001401387
MolPort-003-666-560
MolPort-003-847-014
MRF-0000323
NC00293
NCGC00167537-01
NCGC00167537-02
NSC-737535
NSC-758882
NSC737535
NSC758882
Oprea1_188452
Petrolite E 2020
Pharmakon1600-01504403
PubChem17962
PubChem22271
Q-100096
Q-100098
Q-201040
RT-012410
S-5656
S-6065
s2462
SAM001246627
SAM001247029
SBI-0206789.P001
SC-19032
SC-19033
SC-69061
SCHEMBL1815
SCHEMBL2149
SCHEMBL8265876
SMR000449292
Spectrum_001664
Spectrum5_001662
ST2403759
ST2409236
ST51052741
STK003905
TL8000530
TL8000531
Tox21_112534
Tox21_112534_1
XWAIAVWHZJNZQQ-UHFFFAOYSA-N
Z1741977105

US Patents and Regulatory Information for ARICEPT

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	SOLUTION;ORAL	021719-001	Oct 18, 2004		DISCN	No	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	022568-001	Jul 23, 2010	AB	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial	Y			➤ Try a Free Trial
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	AB	RX	Yes	No	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	AB	RX	Yes	Yes	➤ Try a Free Trial	➤ Try a Free Trial				➤ Try a Free Trial
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 ARICEPT

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	022568-001	Jul 23, 2010	➤ Try a Free Trial	➤ Try a Free Trial
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	➤ Try a Free Trial	➤ Try a Free Trial
Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration

Paragraph IV (Patent) Challenges for ARICEPT

Drugname	Dosage	Strength	RLD	Date
➤ Subscribe	Tablets	23 mg	➤ Subscribe	➤ Try a Free Trial
➤ Subscribe	Orally Disintegrating Tablets	5 mg and 10 mg	➤ Subscribe	➤ Try a Free Trial

International Patents for ARICEPT

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Country	Document Number	Estimated Expiration
South Africa	200705119	➤ Try a Free Trial
World Intellectual Property Organization (WIPO)	2006070930	➤ Try a Free Trial
South Korea	20070086667	➤ Try a Free Trial
South Korea	100904602	➤ Try a Free Trial
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for ARICEPT

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C/GB97/023	United Kingdom	➤ Try a Free Trial	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
1998	Austria	➤ Try a Free Trial	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
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description

Summary for ARICEPT

Pharmacology for ARICEPT

Synonyms for ARICEPT

Paragraph IV (Patent) Challenges for ARICEPT

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