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, Endo Operations, Heritage Pharma, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Natco Pharma, Osmotica Pharm Us, 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. Thirty-eight 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:	38
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	320
Patent Applications:	6,406
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
Duke University	Phase 2
NeuroSense Therapeutics Ltd.	Phase 2
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau	Phase 2

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	206439-001	Dec 23, 2014		RX	Yes	No	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Macleods Pharms Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202631-001	Jan 22, 2014	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-002	Dec 23, 2014		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up			Y	⤷ Sign Up
Abbvie	NAMZARIC	donepezil hydrochloride; memantine hydrochloride	CAPSULE, EXTENDED RELEASE;ORAL	206439-004	Jul 18, 2016	AB	RX	Yes	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Corium	ADLARITY	donepezil hydrochloride	SYSTEM;TRANSDERMAL	212304-002	Mar 11, 2022		RX	Yes	Yes	⤷ 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 ODT	donepezil hydrochloride	TABLET, ORALLY DISINTEGRATING;ORAL	021720-002	Oct 18, 2004	⤷ Sign Up	⤷ Sign Up
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	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	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	⤷ Sign Up	⤷ Sign Up
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-002	Nov 25, 1996	⤷ Sign Up	⤷ Sign Up
Eisai Inc	ARICEPT	donepezil hydrochloride	TABLET;ORAL	020690-001	Nov 25, 1996	⤷ 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
Israel	303255	מערכות ושיטות למתן דרך העור לטווח ארוך (Systems and methods for long term transdermal administration)	⤷ Sign Up
China	101090738	Matrix type sustained-release preparation containing basic drug or salt thereof	⤷ Sign Up
China	101090737	Matrix type sustained-release preparation	⤷ Sign Up
Canada	3032044	SYSTEME D'ADMINISTRATION TRANSDERMIQUE DE DONEPEZIL (DONEPEZIL TRANSDERMAL DELIVERY SYSTEM)	⤷ Sign Up
Canada	3032148	ADMINISTRATION TRANSDERMIQUE ENTRAINEE PAR CONVERSION PAR LE BICARBONATE DE SODIUM IN SITU DE MEDICAMENT AMINE (SODIUM BICARBONATE IN SITU CONVERSION DRIVEN TRANSDERMAL DELIVERY OF AMINE DRUG)	⤷ Sign Up
Japan	2019523268	塩薬物のｉｎｓｉｔｕでの塩から中性の薬物変換による、低溶解度または不安定非イオン化中性薬物の経皮配合物および送達方法	⤷ 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	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
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
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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