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ARICEPT Drug Profile

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Aricept is a drug marketed by Eisai Inc and is included in four NDAs. It is available from eight suppliers. There is one patent protecting this drug and two Paragraph IV challenges.

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

The generic ingredient in ARICEPT is donepezil hydrochloride. There are thirty drug master file entries for this compound. Fifty-six suppliers are listed for this compound. There is one tentative approval for this compound. Additional details are available on the donepezil hydrochloride profile page.

Summary for Tradename: ARICEPT

Patents:1
Applicants:1
NDAs:4
Suppliers / Packagers: see list8
Drug Prices: :see details

Pharmacology for Tradename: ARICEPT

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Eisai Inc
ARICEPT
donepezil hydrochloride
SOLUTION;ORAL021719-001Oct 18, 2004DISCNNo► subscribe► subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 1996RXYes► subscribe► subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL022568-001Jul 23, 2010RXYes8,481,565► subscribeY ► subscribe
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Expired Patents for Tradename: ARICEPT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL022568-001Jul 23, 20104,895,841► subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 19964,895,841► subscribe
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 19964,895,841► subscribe
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Paragraph IV activity for: ARICEPT

Drugname Dosage Strength RLD Submissiondate
donepezil hydrochlorideTablets23 mgAricept7/9/2013
donepezil hydrochlorideOrally Disintegrating Tablets5 mg and 10 mgAricept ODT6/30/2010

Non-Orange Book Patents for Tradename: ARICEPT

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 Tradename: ARICEPT

Country Document Number Estimated Expiration
Israel183650► subscribe
Canada2592605► subscribe
New Zealand555693► 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: ARICEPT

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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