Aricept Patent Expiration

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 active substance like dosage, mode of administration (oral, tablet, capsules, liquids etc).
US5985864 Polymorphs of donepezil hydrochloride and process for production
Dec, 2016

(7 years ago)

Expired
US6140321 Polymorphs of donepezil hydrochloride and process for production
Dec, 2016

(7 years ago)

Expired
US6245911 Donepezil polycrystals and process for producing the same
Dec, 2018

(5 years ago)

Expired
US8481565 Method for stabilizing anti-dementia drug
Oct, 2026

(2 years from now)

Active

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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

Aricept has patent protection in a total of 15 countries. It's US patent count contributes only to 29.2% of its total global patent coverage. 6 countries have all of their patents expired or invalidated which has opened up potential generic launch opportunities in these countries. Click below to unlock the full patent family tree for Aricept.

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Generic Launch

Generic Release Date:

Aricept's generic launch date based on the expiry of its last outstanding patent 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 Generics:

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




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 1996.

Market Authorisation Date:

Aricept was approved by FDA for market use on 25 November, 1996.

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
5MG TABLET Prescription ORAL
10MG TABLET Prescription ORAL
23MG TABLET Prescription ORAL