.

Flexible Flat-Rate Plans

Flat-rate pricing for predictable budgeting

Short-term plans for project- or client-based billing

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

ARICEPT Drug Profile

« Back to Dashboard
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-four 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

Clinical Trials for: 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
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 1996RXYes
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL022568-001Jul 23, 2010RXYes8,481,565Oct 4, 2026Y
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

Expired Patents for Tradename: ARICEPT

These historical archives are available as an add-on to one-year subscriptions.
See the Signup Form for more information.

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL022568-001Jul 23, 20104,895,841<disabled>
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-001Nov 25, 19964,895,841<disabled>
Eisai Inc
ARICEPT
donepezil hydrochloride
TABLET;ORAL020690-002Nov 25, 19964,895,841<disabled>
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Tradename: ARICEPT

Country Document Number Estimated Expiration
Russian Federation2401125<disabled in preview>
BrazilPI0518396<disabled in preview>
South Korea20070089207<disabled in preview>
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ARICEPT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1998Austria<disabled>PRODUCT 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<disabled>PRODUCT 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

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.

`abc