Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

Serving hundreds of leading biopharmaceutical companies globally:

Argus Health
Citi
Deloitte
AstraZeneca
Boehringer Ingelheim
Covington
McKinsey
Accenture
Dow

Generated: April 19, 2018

DrugPatentWatch Database Preview

DONEPEZIL HYDROCHLORIDE - Generic Drug Details

« Back to Dashboard

What are the generic drug sources for donepezil hydrochloride and what is the scope of donepezil hydrochloride freedom to operate?

Donepezil hydrochloride
is the generic ingredient in five branded drugs marketed by Eisai Inc, Barr, 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 Pharms Ltd, Cipla Ltd, Cspc Ouyi Pharm Co, Dexcel Pharma, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Mylan Pharms Inc, Osmotica Pharm Us, Par Pharm, Pliva Hrvatska Doo, Prinston Inc, Sciegen Pharms Inc, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Twi Pharms Inc, Vivimed Global, Wockhardt, Zhejiang Hisun Pharm, Amneal Pharms, and Forest Labs Llc, and is included in fifty-two 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-one drug master file entries for donepezil hydrochloride. Fifty-nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for DONEPEZIL HYDROCHLORIDE
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
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-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
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]
Donepezil Hydrochloride 1.0 mg/ml in Methanol (as free base)
donepezil hydrochloride hydrate
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
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
ST51052741
TL8000530
Tox21_112534
Tox21_112534_1
XWAIAVWHZJNZQQ-UHFFFAOYSA-N
Tentative approvals for DONEPEZIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial5MGTABLET; ORAL
➤ Try a Free Trial➤ Try a Free Trial10MGTABLET; ORAL

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
Sandoz DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 091198-001 May 10, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Dr Reddys Labs Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202723-001 Jul 24, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Sun Pharm Inds DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090493-001 May 31, 2011 AB RX No No ➤ 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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Expired US Patents for DONEPEZIL HYDROCHLORIDE

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Non-Orange Book US Patents for DONEPEZIL HYDROCHLORIDE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,507,527 Method for stabilizing anti-dementia drug ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

Supplementary Protection Certificates for DONEPEZIL HYDROCHLORIDE

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

This preview shows a limited data set. Subscribe for full access, or try a Free Trial

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Queensland Health
McKinsey
QuintilesIMS
Farmers Insurance
Dow
Federal Trade Commission
Teva
Mallinckrodt
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.