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Last Updated: March 19, 2024

Donepezil hydrochloride - Generic Drug Details


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What are the generic drug 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-four patent family members in sixteen countries.

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

Recent Clinical Trials for donepezil hydrochloride

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Fundació 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;21MGCAPSULE, 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
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
Dr Reddys Labs Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201001-002 May 31, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sun Pharm Inds DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090493-001 May 31, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
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
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Zydus Lifesciences DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090100-002 Oct 24, 2012 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 022568-001 Jul 23, 2010 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  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 donepezil hydrochloride TABLET;ORAL 020690-001 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 022568-001 Jul 23, 2010 ⤷  Try a Trial ⤷  Try a Trial
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ⤷  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
European Patent Office 1832298 PREPARATION A LIBERATION CONTROLEE DE TYPE A MATRICE COMPRENANT UNE SUBSTANCE BASIQUE OU UN SEL DE CELLE-CI ET PROCEDE POUR LA PRODUCTION DE CELLE-CI (MATRIX-TYPE CONTROLLED RELEASE PREPARATION COMPRISING BASIC SUBSTANCE OR SALT THEREOF, AND PROCESS FOR PRODUCTION OF THE SAME) ⤷  Try a Trial
South Korea 20230098349 염 약물의 염 약물에서 중성 약물으로의 제자리 전환에 의한 저용해도 또는 불안정한 이온화되지 않은 중성 약물의 경피성 제제 및 전달 방법 (TRANSDERMAL FORMULATION AND DELIVERY METHOD OF LOW SOLUBILITY OR UNSTABLE UNIONIZED NEUTRAL DRUGS BY IN SITU SALT-TO-NEUTRAL DRUG CONVERSION OF SALT DRUG) ⤷  Try a Trial
South Africa 200705118 Method for stabilizing anti-dementia drug ⤷  Try a Trial
Japan 6833855 ⤷  Try a Trial
Hong Kong 1112399 穩定抗痴呆藥物的方法 (METHOD FOR STABILIZING ANTI-DEMENTIA DRUG) ⤷  Try a Trial
Japan 2022140751 塩薬物のin situ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 ⤷  Try a Trial
European Patent Office 3490544 SYSTÈMES D'ADMINISTRATION TRANSDERMIQUE DE MÉMANTINE (MEMANTINE TRANSDERMAL DELIVERY SYSTEMS) ⤷  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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