ARICEPT ODT Drug Patent Profile
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When do Aricept Odt patents expire, and what generic alternatives are available?
Aricept Odt is a drug marketed by Eisai Inc and is included in one NDA.
The generic ingredient in ARICEPT ODT is donepezil hydrochloride. There are thirty-two drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the donepezil hydrochloride profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Aricept Odt
A generic version of ARICEPT ODT was approved as donepezil hydrochloride by AUROBINDO on May 31st, 2011.
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Summary for ARICEPT ODT
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 285 |
| Clinical Trials: | 150 |
| Patent Applications: | 4,015 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ARICEPT ODT |
| DailyMed Link: | ARICEPT ODT at DailyMed |
Recent Clinical Trials for ARICEPT ODT
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Vanderbilt University Medical Center | Early Phase 1 |
| Inventage Lab., Inc. | Phase 1/Phase 2 |
| G2GBio, Inc. | Phase 1 |
Paragraph IV (Patent) Challenges for ARICEPT ODT
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| ARICEPT ODT | Orally Disintegrating Tablets | donepezil hydrochloride | 5 mg and 10 mg | 021720 | 1 | 2010-06-30 |
US Patents and Regulatory Information for ARICEPT ODT
| 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 ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-001 | Oct 18, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-002 | Oct 18, 2004 | DISCN | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for ARICEPT ODT
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-001 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-002 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-002 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-002 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-001 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| Eisai Inc | ARICEPT ODT | donepezil hydrochloride | TABLET, ORALLY DISINTEGRATING;ORAL | 021720-001 | Oct 18, 2004 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for ARICEPT ODT
See the table below for patents covering ARICEPT ODT around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Singapore | 50439 | Cyclic amine compound its use and pharmaceutical compositions comprising it | ⤷ Sign Up |
| Denmark | 1260215 | ⤷ Sign Up | |
| Norway | 882696 | ⤷ Sign Up | |
| Japan | 2009051855 | ORAL PHARMACEUTICAL PREPARATION MASKED TO ELIMINATE BITTERNESS OR LIKE UNPLEASANT TASTE | ⤷ Sign Up |
| China | 1030752 | ⤷ Sign Up | |
| Spain | 2083359 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ARICEPT ODT
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0296560 | 98C0015 | Belgium | ⤷ Sign Up | PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228 |
| 0296560 | 2/1998 | Austria | ⤷ Sign Up | 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 |
| 0296560 | SPC/GB97/023 | United Kingdom | ⤷ Sign Up | 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 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verification 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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