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Last Updated: November 22, 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
Rising DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202656-001 Oct 22, 2015 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sciegen Pharms Inc DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203907-002 Oct 29, 2014 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Natco Pharma DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090521-001 May 31, 2011 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Zydus Lifesciences DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090100-001 Oct 24, 2012 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  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 020690-001 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 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
>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 20180127315 장기 경피 투여를 위한 시스템 및 방법 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2018022815 ⤷  Sign Up
Australia 2005320609 Matrix-type controlled release preparation comprising basic substance or salt thereof, and process for production of the same ⤷  Sign Up
Australia 2023204240 DONEPEZIL TRANSDERMAL DELIVERY SYSTEM ⤷  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 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
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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