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Last Updated: November 4, 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, 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-eight 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
⤷  Sign Up⤷  Sign Up10MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up5MGTABLET; ORAL
⤷  Sign Up⤷  Sign Up10MG;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
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-003 Jul 18, 2016 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-002 Dec 23, 2014 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Zydus Pharms Usa Inc DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 090175-002 May 10, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Indicus Pharma DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201634-002 Jun 13, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Dr Reddys DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202723-001 Jul 24, 2013 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Prinston Inc DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 200292-002 May 31, 2011 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Abbvie NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
>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 ⤷  Sign Up ⤷  Sign Up
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004 ⤷  Sign Up ⤷  Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ⤷  Sign Up ⤷  Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ⤷  Sign Up ⤷  Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ⤷  Sign Up ⤷  Sign Up
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004 ⤷  Sign Up ⤷  Sign Up
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for DONEPEZIL HYDROCHLORIDE

Country Patent Number Title Estimated Expiration
Japan 2022087276 メマンチン経皮送達システム ⤷  Sign Up
Mexico 2018008190 SISTEMAS Y METODOS PARA LA ADMINISTRACION TRANSDERMICA A LARGO PLAZO. (SYSTEMS AND METHODS FOR LONG TERM TRANSDERMAL ADMINISTRATION.) ⤷  Sign Up
South Korea 20190034601 염 약물의 염 약물에서 중성 약물으로의 제자리 전환에 의한 저용해도 또는 불안정한 이온화되지 않은 중성 약물의 경피성 제제 및 전달 방법 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2018022818 ⤷  Sign Up
South Korea 102406528 ⤷  Sign Up
China 116270551 通过盐至中性药物原位转化的组合物、透皮贴剂及应用 (Composition for in-situ transformation from salt to neutral drug, transdermal patch and application) ⤷  Sign Up
Russian Federation 2401125 СПОСОБ СТАБИЛИЗАЦИИ ЛЕКАРСТВЕННОГО СРЕДСТВА ПРОТИВ ДЕМЕНЦИИ (METHOD OF ANTIDEMENTIA DRUG STABILISATION) ⤷  Sign Up
>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 ⤷  Sign Up 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 ⤷  Sign Up 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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