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Last Updated: June 1, 2024

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, Chartwell Rx, 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 Pharms Ltd, Cipla Ltd, Dexcel, Dr Reddys, Dr Reddys Labs Ltd, Heritage Pharma, 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 Lifesciences, Zydus Pharms, Amneal Pharms, Ani Pharms, and Abbvie, and is included in fifty-five NDAs. There are twenty-two 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 twenty-five patent family members in sixteen countries.

There are thirty drug master file entries for donepezil hydrochloride. Forty-one suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for donepezil hydrochloride

International Patents:	125
US Patents:	22
Tradenames:	6
Applicants:	44
NDAs:	55
Drug Master File Entries:	30
Finished Product Suppliers / Packagers:	41
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	317
Patent Applications:	6,406
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for donepezil hydrochloride
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
⤷ Sign Up	⤷ Sign Up	10MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	5MG	TABLET; ORAL
⤷ Sign Up	⤷ Sign Up	10MG;21MG	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
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-003	Jul 18, 2016		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Chartwell Rx	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	078388-001	Nov 26, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Dexcel	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	203713-001	Feb 19, 2016	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	090493-002	May 31, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	076786-001	Nov 26, 2010		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>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	⤷ Sign Up	⤷ Sign Up
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004	⤷ Sign Up	⤷ Sign Up
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-001	Oct 18, 2004	⤷ Sign Up	⤷ Sign Up
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	⤷ Sign Up	⤷ Sign Up
Eisai Inc	ARICEPT ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004	⤷ Sign Up	⤷ Sign Up
>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
China	108697655	用于长期透皮施药的系统和方法 (SYSTEMS AND METHODS FOR LONG TERM TRANSDERMAL ADMINISTRATION)	⤷ Sign Up
China	116966166	碳酸氢钠原位转化驱动胺药物的透皮递送 (Transdermal delivery of sodium bicarbonate in situ conversion driving amine drugs)	⤷ Sign Up
South Korea	20190035801	아민 약물의 나트륨 바이카보네이트 제자리 전환 구동된 경피성 전달	⤷ Sign Up
Japan	2008525313		⤷ Sign Up
Japan	2019504052	長期間経皮投与のためのシステムおよび方法	⤷ Sign Up
>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	SPC/GB97/023	United Kingdom	⤷ Sign Up	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	⤷ Sign Up	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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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