Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 14, 2019

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ARICEPT ODT Drug Profile

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Which patents cover Aricept Odt, and when can generic versions of Aricept Odt launch?

Aricept Odt is a drug marketed by Eisai Inc and is included in one NDA.

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

US ANDA Litigation and Generic Entry Outlook for Aricept Odt

A generic version of ARICEPT ODT was launched as donepezil hydrochloride by SANDOZ on December 14th, 2019.

Drug patent expirations by year for ARICEPT ODT
Recent Clinical Trials for ARICEPT ODT

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

SponsorPhase
The University of Texas Health Science Center at San AntonioPhase 1/Phase 2
Mayo ClinicPhase 1/Phase 2
Dong-A ST Co., Ltd.Phase 1

See all ARICEPT ODT clinical trials

Recent Litigation for ARICEPT ODT

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 ARICEPT ODT litigation

Pharmacology for ARICEPT ODT
Synonyms for ARICEPT ODT
(+-)-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]-
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
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-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-(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
Aricept (TN)
Aricept D
Aricept Evess
BC204600
BC209014
BCP02205
BCP07590
BCP24884
BCP9000622
BCPP000253
BDBM8960
BNAG
BR-49308
BR-72906
BRD-A49160188-003-04-4
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
D4099
DB00843
Domepezil
Donaz (TN)
donepezil
Donepezil (Hydrochloride)
Donepezil (INN)
Donepezil [INN:BAN]
Donepezil HCl
Donepezil HCl (Aricept)
Donepezil hydrochloride
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
donepezilo
donepezilum
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
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 (97%)
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
STK003905
SY110146
TL8000530
TL8000531
Tox21_112534
Tox21_112534_1
XWAIAVWHZJNZQQ-UHFFFAOYSA-N
Z1741977105
Paragraph IV (Patent) Challenges for ARICEPT ODT
Tradename Dosage Ingredient NDA Submissiondate
ARICEPT ODT TABLET, ORALLY DISINTEGRATING;ORAL donepezil hydrochloride 021720 2010-06-30

US Patents and Regulatory Information for ARICEPT ODT

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 ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004 DISCN Yes No   Start Trial   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004 DISCN Yes No   Start Trial   Start Trial   Start 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 ODT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004   Start Trial   Start Trial
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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