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Donepezil hydrochloride - Generic Drug Details

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

This ingredient has thirty-four patent family members in fourteen countries.

There are thirty drug master file entries for donepezil hydrochloride. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: donepezil hydrochloride

Tradenames:4
Patents:14
Applicants:35
NDAs:48
Drug Master File Entries: see list30
Suppliers / Packaging: see list56
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: donepezil hydrochloride

Tentative approvals for DONEPEZIL HYDROCHLORIDE

Applicant Application No. Form Dosage
<disabled><disabled>TABLET; ORAL5MG
<disabled><disabled>TABLET; ORAL10MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-001Dec 23, 2014RXNo8,338,485► subscribeY ► subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-002Dec 23, 2014RXYes8,293,794► subscribeY ► subscribe
Sun Pharm Inds
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL077975-001Dec 11, 2009DISCNNo► subscribe► subscribe
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Expired Orange Book Patents for Generic Ingredient: donepezil hydrochloride

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 19964,895,841► subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL022568-001Jul 23, 20104,895,841► subscribe
Eisai Inc
ARICEPT ODT
donepezil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021720-002Oct 18, 20044,895,841► subscribe
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Non-Orange Book Patents for Generic Ingredient: 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
8,507,527Method for stabilizing anti-dementia drug► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: donepezil hydrochloride

Country Document Number Estimated Expiration
BrazilPI0518396► subscribe
South Korea100904602► subscribe
Mexico2007007836► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DONEPEZIL HYDROCHLORIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1998Austria► subscribePRODUCT 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
C/GB97/023United Kingdom► subscribePRODUCT 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
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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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