Donepezil hydrochloride - Generic Drug Details

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What are the generic sources for donepezil hydrochloride and what is the scope of patent protection?

Donepezil hydrochloride is the generic ingredient in six branded drugs marketed by Eisai Inc, Corium, Heritage Pharma, Hisun Pharm Hangzhou, Macleods Pharms Ltd, Sandoz, Sun Pharm Industries, Unichem, Zydus Pharms Usa Inc, Accord Hlthcare, ACI, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila, Cadila Pharms Ltd, Chartwell Rx, Cipla Ltd, Dexcel, Dr Reddys, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Mylan Pharms Inc, Osmotica Pharm Us, Par Pharm, Prinston Inc, Rising, Sciegen Pharms Inc, Strides Pharma, Sun Pharm, Sun Pharm Inds, Sun Pharm Inds Ltd, Torrent Pharms, Twi Pharms, Wockhardt, Zydus Pharms, Amneal Pharms, and Allergan, and is included in fifty-four NDAs. There are twenty patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Donepezil hydrochloride has one hundred and seven patent family members in sixteen countries.

There are thirty drug master file entries for donepezil hydrochloride. Thirty-nine suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for donepezil hydrochloride

International Patents:	107
US Patents:	20
Tradenames:	6
Applicants:	43
NDAs:	54
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	152
Clinical Trials:	317
Patent Applications:	6,406
Formulation / Manufacturing:	see details
What excipients (inactive ingredients) are in donepezil hydrochloride?	donepezil hydrochloride excipients list
DailyMed Link:	donepezil hydrochloride at DailyMed

Recent Clinical Trials for donepezil hydrochloride

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

Sponsor	Phase
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Phase 2
National Institute on Aging (NIA)	Phase 2/Phase 3
The University of Texas Health Science Center at San Antonio	Phase 2/Phase 3

See all donepezil hydrochloride clinical trials

Generic filers with tentative approvals for DONEPEZIL HYDROCHLORIDE

Applicant	Application No.	Strength	Dosage Form
⤷ Try a Trial	⤷ Try a Trial	10MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	5MG	TABLET; ORAL
⤷ Try a Trial	⤷ Try a Trial	10MG;28MG	CAPSULE, EXTENDED RELEASE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for donepezil hydrochloride

Drug Class	Cholinesterase Inhibitor
Mechanism of Action	Cholinesterase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for donepezil hydrochloride

N06DA	Anticholinesterases
N06D	ANTI-DEMENTIA DRUGS
N06	PSYCHOANALEPTICS
N	Nervous system

Paragraph IV (Patent) Challenges for DONEPEZIL HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
ARICEPT	Tablets	donepezil hydrochloride	23 mg	022568		2013-07-09
ARICEPT ODT	Orally Disintegrating Tablets	donepezil hydrochloride	5 mg and 10 mg	021720	1	2010-06-30

US Patents and Regulatory Information for donepezil hydrochloride

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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
Accord Hlthcare	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201335-002	Aug 29, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Heritage Pharma	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	077344-001	May 31, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Sun Pharm Inds Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	076786-002	Nov 26, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Allergan	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016		RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Heritage Pharma	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	077344-002	May 31, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a 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 donepezil hydrochloride

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	⤷ Try a Trial	⤷ Try a Trial
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004	⤷ Try a Trial	⤷ Try a Trial
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004	⤷ Try a Trial	⤷ Try a Trial
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	⤷ Try a Trial	⤷ Try a Trial
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004	⤷ Try a Trial	⤷ Try a Trial
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for donepezil hydrochloride

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Country	Patent Number	Title	Estimated Expiration
South Korea	102406536		⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2018022816		⤷ Try a Trial
New Zealand	555693	Matrix type sustained-release preparation containing donepezil	⤷ Try a Trial
World Intellectual Property Organization (WIPO)	2018022817		⤷ Try a Trial
Mexico	2019001104	SISTEMAS DE SUMINISTRO TRANSDERMICO DE MEMANTINA. (MEMANTINE TRANSDERMAL DELIVERY SYSTEMS.)	⤷ Try a Trial
Australia	2005320609	Matrix-type controlled release preparation comprising basic substance or salt thereof, and process for production of the same	⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for donepezil hydrochloride

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

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