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Last Updated: June 4, 2023

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

SponsorPhase
FundaciĆ³ Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPhase 2
National Institute on Aging (NIA)Phase 2/Phase 3
The University of Texas Health Science Center at San AntonioPhase 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 Trial10MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial5MGTABLET; ORAL
⤷  Try a Trial⤷  Try a Trial10MG;28MGCAPSULE, 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
Anatomical Therapeutic Chemical (ATC) Classes for donepezil hydrochloride
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

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

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

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

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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McKesson
Merck

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