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Last Updated: December 14, 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, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila Pharms Ltd, Cipla Ltd, Dexcel, Dr Reddys, Dr Reddys Labs Ltd, Endo Operations, Esjay Pharma, 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-nine suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for donepezil hydrochloride
Recent Clinical Trials for donepezil hydrochloride

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

SponsorPhase
Duke UniversityPhase 2
NeuroSense Therapeutics Ltd.Phase 2
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant PauPhase 2

See all donepezil hydrochloride clinical trials

Generic filers with tentative approvals for DONEPEZIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
⤷  Subscribe⤷  Subscribe10MGTABLET; ORAL
⤷  Subscribe⤷  Subscribe5MGTABLET; ORAL
⤷  Subscribe⤷  Subscribe10MG;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
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
Esjay Pharma DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090551-001 May 31, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Dr Reddys Labs Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201001-001 May 31, 2011 AB RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 RX Yes No 8,338,485 ⤷  Subscribe Y ⤷  Subscribe
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No 8,338,485 ⤷  Subscribe Y ⤷  Subscribe
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No 8,580,858 ⤷  Subscribe ⤷  Subscribe
Corium ADLARITY donepezil hydrochloride SYSTEM;TRANSDERMAL 212304-002 Mar 11, 2022 RX Yes Yes 10,966,936 ⤷  Subscribe Y ⤷  Subscribe
>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 022568-001 Jul 23, 2010 4,895,841 ⤷  Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 4,895,841 ⤷  Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 6,245,911 ⤷  Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 4,895,841 ⤷  Subscribe
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004 4,895,841 ⤷  Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 5,985,864 ⤷  Subscribe
>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 20220082929 아민 약물의 나트륨 바이카보네이트 제자리 전환 구동된 경피성 전달 (SODIUM BICARBONATE IN SITU CONVERSION DRIVEN TRANSDERMAL DELIVERY OF AMINE DRUG) ⤷  Subscribe
South Korea 20190035801 아민 약물의 나트륨 바이카보네이트 제자리 전환 구동된 경피성 전달 ⤷  Subscribe
Russian Federation 2018127642 СИСТЕМЫ И СПОСОБЫ ДЛИТЕЛЬНОГО ТРАНСДЕРМАЛЬНОГО ВВЕДЕНИЯ ⤷  Subscribe
Canada 3031945 FORMULATION TRANSDERMIQUE ET PROCEDE D'ADMINISTRATION D'UN MEDICAMENT DE FORME NEUTRE NON IONISE DE FAIBLE SOLUBILITE OU INSTABLE PAR CONVERSION SEL DE MEDICAMENT SUR PLACE D'UN M EDICAMENT DE FORME NEUTRE A FORME SEL (TRANSDERMAL FORMULATION AND DELIVERY METHOD OF LOW SOLUBILITY OR UNSTABLE UNIONIZED NEUTRAL DRUGS BY IN SITU SALT-TO-NEUTRAL DRUG CONVERSION OF SALT DRUG) ⤷  Subscribe
South Africa 200705119 Matrix type sustained-release preparation containing basic drug or salt thereof, and method for manufacturing the same ⤷  Subscribe
South Korea 20190032512 도네페질 경피 전달 시스템 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for donepezil hydrochloride

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0296560 SPC/GB97/023 United Kingdom ⤷  Subscribe 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
0296560 2/1998 Austria ⤷  Subscribe 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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