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

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: November 18, 2019

DrugPatentWatch Database Preview

DONEPEZIL HYDROCHLORIDE Drug Profile

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Which patents cover Donepezil Hydrochloride, and when can generic versions of Donepezil Hydrochloride launch?

Donepezil Hydrochloride is a drug marketed by 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, and Zydus Pharms. and is included in forty-seven NDAs.

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

Drug patent expirations by year for DONEPEZIL HYDROCHLORIDE
Recent Clinical Trials for DONEPEZIL HYDROCHLORIDE

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SponsorPhase
Zealand University HospitalPhase 4
Epilepsihospitalet FiladelfiaPhase 4
Shanghai Synergy Pharmaceutical Sciences Co., Ltd.Phase 1

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

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
Paragraph IV (Patent) Challenges for DONEPEZIL HYDROCHLORIDE
Tradename Dosage Ingredient NDA Submissiondate
ARICEPT TABLET;ORAL donepezil hydrochloride 022568 2013-07-09
ARICEPT ODT TABLET, ORALLY DISINTEGRATING;ORAL donepezil hydrochloride 021720 2010-06-30
ARICEPT TABLET;ORAL donepezil hydrochloride 020690

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
Sun Pharm Inds Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 076786-001 Nov 26, 2010 DISCN No No   Start Trial   Start Trial   Start Trial
Hetero Labs Ltd V DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203034-002 Jan 30, 2015 AB RX No No   Start Trial   Start Trial   Start Trial
Cspc Ouyi DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202114-001 Jul 5, 2013 AB RX No No   Start Trial   Start Trial   Start Trial
Jubilant Generics DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090768-002 May 31, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Pliva Hrvatska Doo DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090425-002 May 31, 2011 AB RX No No   Start Trial   Start Trial   Start Trial
Indicus Pharma DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201634-001 Jun 13, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202782-001 Oct 30, 2015 AB RX No 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

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Serving leading biopharmaceutical companies globally:

Dow
Moodys
Mallinckrodt
Merck
Express Scripts
Colorcon

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