Donepezil Hydrochloride Patent Expiration
Donepezil Hydrochloride was first introduced by Eisai Inc
Donepezil Hydrochloride Patents
Given below is the list of patents protecting Donepezil Hydrochloride, along with the drug name that holds that patent and the company name owning that drug.
| Drug Used in | Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Drug Owner |
|---|---|---|---|---|
| Adlarity | US10966936 | Systems comprising a composite backing and methods for long term transdermal administration | Aug 11, 2038 | Corium |
| Adlarity | US10835499 | Systems and methods for long term transdermal administration | May 20, 2038 | Corium |
| Adlarity | US11648214 | Systems and methods for long term transdermal administration | Sep 23, 2037 | Corium |
| Adlarity | US10016372 | Transdermal delivery systems with pharmacokinetics bioequivalent to oral delivery | Jul 26, 2037 | Corium |
| Adlarity | US10300025 | Donepezil transdermal delivery system | Jul 26, 2037 | Corium |
| Adlarity | US10307379 | Donepezil transdermal delivery system | Jul 26, 2037 | Corium |
| Adlarity | US11103463 | Methods for treating alzheimer's disease with donepezil transdermal system | Jul 26, 2037 | Corium |
| Adlarity | US9993466 | Donepezil transdermal delivery system | Jul 26, 2037 | Corium |
| Adlarity | US11679086 | Systems comprising a composite backing and methods for long term transdermal administration | May 26, 2037 | Corium |
| Adlarity | US12161767 | Systems and methods for long term transdermal administration | Dec 30, 2036 | Corium |
| Adlarity | US12168075 | Systems comprising a composite backing and methods for long term transdermal administration | Dec 30, 2036 | Corium |
| Aricept | US8481565 | Method for stabilizing anti-dementia drug |
Oct 04, 2026
(Expired) | Eisai Inc |
| Aricept Odt | US7727548 | Rapidly disintegrable tablet containing polyvinyl alcohol |
Jun 23, 2022
(Expired) | Eisai Inc |
| Aricept | US6245911 | Donepezil polycrystals and process for producing the same |
Dec 01, 2018
(Expired) | Eisai Inc |
| Aricept Odt | US7727552 | Oral pharmaceutical preparations decreased in bitterness by masking |
Mar 26, 2018
(Expired) | Eisai Inc |
| Aricept | US5985864 | Polymorphs of donepezil hydrochloride and process for production |
Dec 30, 2016
(Expired) | Eisai Inc |
| Aricept | US6140321 | Polymorphs of donepezil hydrochloride and process for production |
Dec 30, 2016
(Expired) | Eisai Inc |
Donepezil Hydrochloride's Family Patents
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Clinical Trials
Recent Clinical Trials on Donepezil Hydrochloride:
Sometimes companies keep conducting clinical trials even after the drug's approval to discover new formulations, methods of use, or new treatment indications, so they could file for additional patents or receive regulatory exclusivity extensions, such as pediatric exclusivity, potentially delaying generic competition. Based on these recent clinical trials, generic companies need to consider the potential for new intellectual property or regulatory hurdles. These strategic moves by the drug owner might delay generic substitution or lead to additional sales of the brand drug, even after patent expiry.
| Title | Lead Sponsor | Collaborators | Status | Phases |
|---|---|---|---|---|
 | ||||
| Clinical Study to Evaluate the Efficacy and Safety of Huperzine A Controlled-Release Tablets in Patients With Mild-to-Moderate Dementia of the Alzheimer's Type | Wanbangde Pharmaceutical Group Co., LTD | NA |
RECRUITING
(Aug 1, 2026)
| PHASE2, PHASE3 |
| Pharmacokinetic Study of GB-5001A 280 mg Long Acting Injection, in Comparison With the Comparator Drug Aricept® 5 mg and Aricept® 10 mg Film-coated Tablet in Healthy Subjects | G2GBio, Inc. | NA |
COMPLETED
(Aug 1, 2026)
| PHASE1 |
| Investigating the Cholinergic Contribution to Gait Dysfunction in Parkinson's Disease | University of Virginia | NA |
COMPLETED
(Mar 1, 2026)
| PHASE2 |