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Generated: June 27, 2017
What is the patent landscape for Aricept, and what generic Aricept 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.| Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 4 |
| Suppliers / Packagers: see list | 9 |
| Bulk Api Vendors: see list | 144 |
| Clinical Trials: see list | 121 |
| Patent Applications: see list | 2,811 |
| Formulation / Manufacturing: | see details |
| Drug Prices: | see details |
| DailyMed Link: | ARICEPT at DailyMed |
| Drug Class | Cholinesterase Inhibitor |
| Mechanism of Action | Cholinesterase Inhibitors |
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eisai Inc | ARICEPT | donepezil hydrochloride | SOLUTION;ORAL | 021719-001 | Oct 18, 2004 | DISCN | No | No | ► Subscribe | ► Subscribe | |||||||||||||||||||
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 022568-001 | Jul 23, 2010 | AB | RX | Yes | Yes | 8,481,565 | ► Subscribe | Y | ► Subscribe | ||||||||||||||||
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-002 | Nov 25, 1996 | AB | RX | Yes | No | ► Subscribe | ► Subscribe | ||||||||||||||||||
Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-002 | Oct 18, 2004 | AB | RX | Yes | Yes | ► Subscribe | ► Subscribe | ||||||||||||||||||
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| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-002 | Nov 25, 1996 | 6,140,321 | ► Subscribe | ||||||||||||||||||||||
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | 5,985,864 | ► Subscribe | ||||||||||||||||||||||
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 022568-001 | Jul 23, 2010 | 4,895,841 | ► Subscribe | ||||||||||||||||||||||
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-002 | Nov 25, 1996 | 5,985,864 | ► Subscribe | ||||||||||||||||||||||
Eisai Inc | ARICEPT | donepezil hydrochloride | TABLET;ORAL | 020690-001 | Nov 25, 1996 | 6,140,321 | ► Subscribe | ||||||||||||||||||||||
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| Drugname | Dosage | Strength | RLD | Submissiondate |
|---|---|---|---|---|
| donepezil hydrochloride | Tablets | 23 mg | Aricept | 7/9/2013 |
| donepezil hydrochloride | Orally Disintegrating Tablets | 5 mg and 10 mg | Aricept ODT | 6/30/2010 |
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 | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 8,507,527 | Method 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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| Country | Document Number | Estimated Expiration | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mexico | 2007007836 | ► Subscribe | |||||||||||||||||||||||||||
| Russian Federation | 2390354 | ► Subscribe | |||||||||||||||||||||||||||
| Israel | 183871 | ► Subscribe | |||||||||||||||||||||||||||
| China | 101090737 | ► Subscribe | |||||||||||||||||||||||||||
| New Zealand | 555901 | ► 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 Certificate | SPC Country | SPC Expiration | SPC Description | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1998 | Austria | ► Subscribe | 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/GB97/023 | United Kingdom | ► Subscribe | 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 | ||||||||||||||||||||||||||
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Serving 500+ biopharmaceutical companies globally:
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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