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Serving leading biopharmaceutical companies globally:

Citi
Cipla
Queensland Health
Chubb
Dow
Novartis
Merck
Colorcon
Healthtrust
Fish and Richardson

Generated: December 12, 2017

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ARICEPT Drug Profile

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When do Aricept patents expire, and what generic alternatives are available?

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

This drug has thirty-six patent family members in fifteen countries and two supplementary protection certificates in two countries.

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

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Eisai IncARICEPTdonepezil hydrochlorideSOLUTION;ORAL021719-001Oct 18, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL022568-001Jul 23, 2010ABRXYesYes► Subscribe► Subscribe► SubscribeY► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL020690-002Nov 25, 1996ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL020690-001Nov 25, 1996ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Eisai IncARICEPT ODTdonepezil hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL021720-002Oct 18, 2004ABRXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Eisai IncARICEPT ODTdonepezil hydrochlorideTABLET, ORALLY DISINTEGRATING;ORAL021720-001Oct 18, 2004ABRXYesNo► Subscribe► Subscribe► Subscribe► Subscribe
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Expired Patents for Tradename: ARICEPT

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL022568-001Jul 23, 2010► Subscribe► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL020690-002Nov 25, 1996► Subscribe► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL020690-001Nov 25, 1996► Subscribe► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL020690-001Nov 25, 1996► Subscribe► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL020690-001Nov 25, 1996► Subscribe► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL020690-002Nov 25, 1996► Subscribe► Subscribe
Eisai IncARICEPTdonepezil hydrochlorideTABLET;ORAL020690-002Nov 25, 1996► Subscribe► Subscribe
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Paragraph IV (Patent) Challenges 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
BrazilPI0518396► Subscribe
South Africa200705119► Subscribe
Mexico2007007835► Subscribe
World Intellectual Property Organization (WIPO)2006070930► Subscribe
Japan5514249► Subscribe
Japan4999466► Subscribe
Australia2005320609► Subscribe
JapanWO2006070781► Subscribe
South Korea20070086667► Subscribe
World Intellectual Property Organization (WIPO)2006070781► 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
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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Serving leading biopharmaceutical companies globally:

Fuji
Chubb
Johnson and Johnson
AstraZeneca
McKesson
Teva
Deloitte
Cerilliant
Covington
UBS

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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