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Donepezil hydrochloride - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for donepezil hydrochloride?

Donepezil hydrochloride is the generic ingredient in five 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, Amneal Pharms, and Forest Labs Llc, and is included in forty-nine NDAs. There are fourteen patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

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

There are thirty-one 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:5
Patents:14
Applicants:36
NDAs:49
Drug Master File Entries: see list31
Suppliers / Packagers: see list56
Bulk Api Vendors: see list81
Clinical Trials: see list1,080
Patent Applications: see list4,552
Therapeutic Class:Antidementia Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:donepezil hydrochloride at DailyMed

Pharmacology for Ingredient: donepezil hydrochloride

Tentative approvals for DONEPEZIL HYDROCHLORIDE

Applicant Application No. Form Dosage
► Subscribe► SubscribeTABLET; ORAL5MG
► Subscribe► SubscribeTABLET; ORAL10MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Cipla Ltd
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL077518-002May 31, 2011RXNoNo► Subscribe► Subscribe
Accord Hlthcare
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL201335-001Aug 29, 2011DISCNNoNo► Subscribe► Subscribe
Mylan Pharms Inc
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL090521-001May 31, 2011RXNoNo► Subscribe► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-003Jul 18, 2016RXYesNo8,058,291► Subscribe ► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-002Dec 23, 2014RXYesYes8,173,708*PED► SubscribeY► 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 ODT
donepezil hydrochloride
TABLET, ORALLY DISINTEGRATING;ORAL021720-001Oct 18, 20044,895,841► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 19966,140,321► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 19966,140,321► Subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 19965,985,864► 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
Israel183650► Subscribe
Russian Federation2007128767► Subscribe
Mexico2007007836► Subscribe
Australia2005320547► Subscribe
Canada2592605► 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
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
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
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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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