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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Baxter
UBS
McKesson
McKinsey
US Department of Justice
Deloitte
Healthtrust
Argus Health
Johnson and Johnson

Generated: January 21, 2018

DrugPatentWatch Database Preview

Donepezil hydrochloride - Generic Drug Details

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What are the generic drug sources for donepezil hydrochloride and what is the scope of donepezil hydrochloride patent protection?

Donepezil hydrochloride
is the generic ingredient in five branded drugs marketed by Eisai Inc, Barr, Macleods Pharms Ltd, Sandoz, Sun Pharm Industries, Unichem Labs Ltd, Zydus Pharms Usa Inc, Accord Hlthcare, Aci Healthcare Ltd, Actavis Elizabeth, Alembic Pharms Ltd, Apotex, Aurobindo, Cadila Pharms Ltd, Cipla Ltd, Cspc Ouyi Pharm Co, Dexcel Pharma, Dr Reddys Labs Ltd, Hetero Labs Ltd V, Hikma Pharms, Indicus Pharma, Jubilant Generics, Lupin Ltd, Mylan Pharms Inc, Osmotica Pharm Us, Par Pharm, Pliva Hrvatska Doo, Prinston Inc, Sciegen Pharms Inc, Sun Pharm Inds, Sun Pharm Inds Ltd, Teva, Torrent Pharms, Twi Pharms Inc, Vivimed Global, Wockhardt, Zhejiang Hisun Pharm, Amneal Pharms, and Forest Labs Llc, and is included in fifty-two NDAs. There are thirteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Donepezil hydrochloride has thirty-six patent family members in fifteen countries.

There are thirty-one drug master file entries for donepezil hydrochloride. Fifty-nine suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for donepezil hydrochloride
Pharmacology for donepezil hydrochloride
Tentative approvals for DONEPEZIL HYDROCHLORIDE
Applicant Application No. Strength Dosage Form
➤ Subscribe➤ Subscribe5MGTABLET; ORAL
➤ Subscribe➤ Subscribe10MGTABLET; ORAL

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
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Accord Hlthcare DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 201335-001 Aug 29, 2011 DISCN No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Zydus Pharms Usa Inc DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 203162-001 Aug 31, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-001 Dec 23, 2014 AB RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Zhejiang Hisun Pharm DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 202410-001 Mar 24, 2017 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Forest Labs Llc NAMZARIC donepezil hydrochloride; memantine hydrochloride CAPSULE, EXTENDED RELEASE;ORAL 206439-004 Jul 18, 2016 RX Yes No ➤ Subscribe ➤ Subscribe Y ➤ Subscribe
Aurobindo DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 090056-001 May 31, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Unichem Labs Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 204831-001 Nov 10, 2016 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Aci Healthcare Ltd DONEPEZIL HYDROCHLORIDE donepezil hydrochloride TABLET;ORAL 078662-002 May 31, 2011 AB RX No No ➤ Subscribe ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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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 ➤ Subscribe ➤ Subscribe
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-001 Oct 18, 2004 ➤ Subscribe ➤ Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ➤ Subscribe ➤ Subscribe
Eisai Inc ARICEPT ODT donepezil hydrochloride TABLET, ORALLY DISINTEGRATING;ORAL 021720-002 Oct 18, 2004 ➤ Subscribe ➤ Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ➤ Subscribe ➤ Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ➤ Subscribe ➤ Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-002 Nov 25, 1996 ➤ Subscribe ➤ Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 020690-001 Nov 25, 1996 ➤ Subscribe ➤ Subscribe
Eisai Inc ARICEPT donepezil hydrochloride TABLET;ORAL 022568-001 Jul 23, 2010 ➤ Subscribe ➤ Subscribe
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for donepezil hydrochloride

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,507,527 Method for stabilizing anti-dementia drug ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for donepezil hydrochloride

Supplementary Protection Certificates for donepezil hydrochloride

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
C/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
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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Chubb
Teva
Julphar
Healthtrust
Colorcon
Johnson and Johnson
Novartis
Boehringer Ingelheim
Queensland Health

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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