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ARICEPT Drug Profile

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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.

This drug has thirty-six patent family members in fifteen countries.

The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Forty-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

A generic version of ARICEPT was approved as donepezil hydrochloride by SANDOZ on January 26^th, 2020.

Summary for ARICEPT

International Patents:	36
US Patents:	1
Applicants:	1
NDAs:	4
Suppliers / Packagers:	2
Bulk Api Vendors:	212
Clinical Trials:	130
Patent Applications:	4,215
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for ARICEPT
Drug Sales Revenues:	Drug sales revenues for ARICEPT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ARICEPT
DailyMed Link:	ARICEPT at DailyMed

See drug prices for ARICEPT

See drug sales revenues for ARICEPT

Recent Clinical Trials for ARICEPT

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

Sponsor	Phase
The University of Texas Health Science Center at San Antonio	Phase 1/Phase 2
Mayo Clinic	Phase 1/Phase 2
Dong-A ST Co., Ltd.	Phase 1

See all ARICEPT clinical trials

Recent Litigation for ARICEPT

Identify potential future generic entrants

District Court Litigation

Case Name	Date
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 litigation

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]-

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 (TN)

Aricept D

Aricept Evess

Aricept ODT

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

Tradename	Dosage	Ingredient	NDA	Submissiondate
ARICEPT	TABLET;ORAL	donepezil hydrochloride	022568	2013-07-09
ARICEPT	TABLET;ORAL	donepezil hydrochloride	020690

US Patents and Regulatory Information for ARICEPT

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
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	022568-001	Jul 23, 2010	AB	RX	Yes	Yes			Y
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	AB	RX	Yes	No
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	AB	RX	Yes	Yes

Expired US Patents for ARICEPT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996

International Patents for ARICEPT

Country	Patent Number	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006070781
Mexico	2007007835
Russian Federation	2007128767
Russian Federation	2390354

Supplementary Protection Certificates for ARICEPT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0296560	SPC/GB97/023	United Kingdom		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
0296560	2/1998	Austria		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