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Last Updated: March 28, 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
The University of Texas Health Science Center at San AntonioPhase 2/Phase 3
National Institute on Aging (NIA)Phase 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
Sun Pharm Inds DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090493-002 May 31, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 091198-001 May 10, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Prinston Inc DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 200292-001 May 31, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hisun Pharm Hangzhou DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 205269-001 Jul 27, 2018 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
>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 ⤷  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 021720-001 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 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 3490559 SYSTÈMES D'ADMINISTRATION TRANSDERMIQUE À PHARMACOCINÉTIQUE BIOÉQUIVALENT À L'ADMINISTRATION ORALE (TRANSDERMAL DELIVERY SYSTEMS WITH PHARMACOKINETICS BIOEQUIVALENT TO ORAL DELIVERY) ⤷  Try a Trial
Japan 2008525313 ⤷  Try a Trial
European Patent Office 3490540 ADMINISTRATION TRANSDERMIQUE ENTRAÎNÉE PAR CONVERSION PAR LE BICARBONATE DE SODIUMIN SITU (SODIUM BICARBONATEIN SITU) ⤷  Try a Trial
Israel 260290 מערכות ושיטות למתן דרך העור לטווח ארוך (Systems and methods for long term transdermal administration) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2018022817 ⤷  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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