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Last Updated: April 25, 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, 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, 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. Forty-one 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 SANDOZ on May 10^th, 2011.

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Summary for DONEPEZIL HYDROCHLORIDE

US Patents:	0
Applicants:	39
NDAs:	47
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	317
Patent Applications:	4,015
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

Drug patent expirations by year for DONEPEZIL HYDROCHLORIDE

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

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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Hikma Pharms	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	090247-001	May 31, 2011		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Cipla Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	077518-002	May 31, 2011	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Macleods Pharms Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201146-001	Aug 17, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Rising	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	202656-001	Oct 22, 2015		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Indicus Pharma	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201634-002	Jun 13, 2012	AB	RX	No	No	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Macleods Pharms Ltd	DONEPEZIL HYDROCHLORIDE	donepezil hydrochloride	TABLET;ORAL	201146-002	Aug 17, 2012	AB	RX	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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.