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Last Updated: November 2, 2024

DONEPEZIL HYDROCHLORIDE Drug Patent 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 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, 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. Thirty-eight suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Donepezil Hydrochloride

A generic version of DONEPEZIL HYDROCHLORIDE was approved as donepezil hydrochloride by ACI on May 31^st, 2011.

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Summary for DONEPEZIL HYDROCHLORIDE

US Patents:	0
Applicants:	39
NDAs:	47
Finished Product Suppliers / Packagers:	36
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	320
Patent Applications:	4,015
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

Drug patent expirations by year for DONEPEZIL HYDROCHLORIDE

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

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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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent Pharms	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	090686-001	May 31, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Hetero Labs Ltd V	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	203034-002	Jan 30, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Cipla Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	077518-002	May 31, 2011	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Lupin Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202782-001	Oct 30, 2015	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Rising	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202656-001	Oct 22, 2015		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Indicus Pharma	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201634-001	Jun 13, 2012	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Macleods Pharms Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201146-001	Aug 17, 2012	AB	RX	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

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