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Generated: May 24, 2017

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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 Zydus Pharms Usa Inc, Dr Reddys Labs Ltd, Twi Pharms Inc, Sciegen Pharms Inc, Zhejiang Hisun Pharm, 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, Allied Pharma Inc, 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 fifty 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-eight 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:37
NDAs:50
Drug Master File Entries: see list31
Suppliers / Packagers: see list58
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. Strength Dosage Form
► Subscribe► Subscribe5MGTABLET; ORAL
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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;ORAL206439-001Dec 23, 2014ABRXYesNo8,293,794► SubscribeY ► Subscribe
Forest Labs Llc
NAMZARIC
donepezil hydrochloride; memantine hydrochloride
CAPSULE, EXTENDED RELEASE;ORAL206439-001Dec 23, 2014ABRXYesNo8,283,379*PED► SubscribeY► Subscribe
Aurobindo
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL090056-002May 31, 2011ABRXNoNo► Subscribe► Subscribe
Mylan Pharms Inc
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL090521-002May 31, 2011ABRXNoNo► Subscribe► Subscribe
Alembic Pharms Ltd
DONEPEZIL HYDROCHLORIDE
donepezil hydrochloride
TABLET;ORAL201724-001Feb 25, 2013ABRXNoNo► Subscribe► Subscribe
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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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