Aricept is a drug owned by Eisai Inc. It is protected by 4 US drug patents filed in 2013. Out of these, 1 drug patents are active and 3 have expired. Based on its patents and exclusivities, its generic launch date is estimated to be Oct 04, 2026. Details of Aricept's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US8481565 | Method for stabilizing anti-dementia drug |
Oct, 2026
(11 months from now) | Active |
| US6245911 | Donepezil polycrystals and process for producing the same |
Dec, 2018
(6 years ago) |
Expired
|
| US6140321 | Polymorphs of donepezil hydrochloride and process for production |
Dec, 2016
(8 years ago) |
Expired
|
| US5985864 | Polymorphs of donepezil hydrochloride and process for production |
Dec, 2016
(8 years ago) |
Expired
|
A patent's expiry date may change depending upon legal activities going on that patent. Critical
activities like
abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease
the life of a
patent hence affecting its expiry date and in turn affecting the generic launch date of that drug.
Tracking these
ongoing activities on a patent application helps to keep an eye on the latest developments in the
patent process of
the drug which can give an idea of how early a drug's generic could be available. The next section
provides a list of
recent legal activities on Aricept's patents.
Latest Legal Activities on Aricept's Patents
Given below is the list of recent legal activities going on the following patents of Aricept.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| Payment of Maintenance Fee, 8th Year, Large Entity | 22 Sep, 2020 | US8481565 |
| Correspondence Address Change
Critical | 03 Dec, 2018 | US8481565 |
| Post Issue Communication - Certificate of Correction | 17 Apr, 2015 | US8481565 |
| Email Notification
Critical | 19 Feb, 2015 | US8481565 |
| Mail-Petition Decision - Dismissed
Critical | 10 Feb, 2015 | US8481565 |
| Petition Decision - Dismissed
Critical | 09 Feb, 2015 | US8481565 |
| Adjustment of PTA Calculation by PTO | 02 Feb, 2015 | US8481565 |
| Petition Entered | 09 Sep, 2013 | US8481565 |
| Patent Issue Date Used in PTA Calculation
Critical | 09 Jul, 2013 | US8481565 |
| Recordation of Patent Grant Mailed
Critical | 09 Jul, 2013 | US8481565 |
FDA has granted several exclusivities to Aricept. Till the time
these exclusivities
are active, no other company can market a generic or bioequivalent version of Aricept, regardless of the status of it's patents. These exclusivities hence play a crucial role in
delaying the generic
launch. Given below are details of the exclusivities granted to
Aricept.
Exclusivity Information
Aricept holds 1 exclusivities. All of its exclusivities have expired in 2013. Details of Aricept's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 23, 2013 |
US patents provide insights into the exclusivity only within the United States, but
Aricept is protected by patents in multiple countries.
Understanding
the full scope
of patent protection is crucial in strategizing market entry. By looking at the broader patent
landscape, you can
identify markets with weaker patent protection which could be ideal generic entry points. The
following section offers
details on Aricept's family patents as well as insights into
ongoing legal events
on those patents.
Aricept's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Aricept's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Oct 04, 2026 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Aricept Generic API suppliers:
Donepezil Hydrochloride is the generic name for the brand Aricept. 39 different companies have already filed for the generic of Aricept, with Chartwell Rx having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Aricept's generic
How can I launch a generic of Aricept before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Aricept's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Aricept's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Aricept -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 5 mg and 10 mg | |||||
| 23 mg | 09 Jul, 2013 | 24 Jul, 2013 | 04 Oct, 2026 | Eligible |
Alternative Brands for Aricept
There are several other brand drugs using the same active ingredient (Donepezil Hydrochloride) as Aricept. Given below is the list of those companies and their brand drugs, to help you identify new opportunities, assess competitors, and plan your market strategies more effectively.
| Drug Owner | Drug Name | |
|---|---|---|
| Abbvie |
| |
| Corium |
| |
| Eisai Inc |
|
Apart from brand drugs containing the same ingredient, some generics have also been filed for Donepezil Hydrochloride, Aricept's active ingredient. Check the complete list of approved generic manufacturers for Aricept
About Aricept
Aricept is a drug owned by Eisai Inc. Aricept uses Donepezil Hydrochloride as an active ingredient. Aricept was launched by Eisai Inc in 2010.
Approval Date:
Aricept was approved by FDA for market use on 23 July, 2010.
Active Ingredient:
Aricept uses Donepezil Hydrochloride as the active ingredient. Check out other Drugs and Companies using Donepezil Hydrochloride ingredient
Dosage:
Aricept is available in tablet form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 23MG | TABLET | Prescription | ORAL |
| 10MG | TABLET | Prescription | ORAL |
| 5MG | TABLET | Prescription | ORAL |