Donepezil
Adlarity, Aricept, Donepezil, Namzaric (donepezil) is a small molecule pharmaceutical. Donepezil was first approved as Aricept on 1996-11-25. It is used to treat alzheimer disease in the USA. The pharmaceutical is active against acetylcholinesterase.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| nervous system diseases | D009422 |
| mental disorders | D001523 |
Trade Name
FDA
EMA
Adlarity, Aricept, Donepezil (discontinued: Aricept, Donepezil)
CombinationsMemantine donepezil, Namzaric (discontinued: Memantine donepezil)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Donepezil hydrochloride
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| adlarity | New Drug Application | 2023-02-17 |
| aricept | New Drug Application | 2022-11-15 |
| donepezil | ANDA | 2024-09-25 |
| donepezil donepezil hydrochloride | ANDA | 2019-10-09 |
| donepezil hydrochloride | ANDA | 2024-11-07 |
| donepezil hydrochloride donepezil hyrochloride | ANDA | 2019-02-16 |
| memantine and donepezil hydrochlorides extended-release | ANDA | 2020-12-29 |
| namzaric | New Drug Application | 2024-05-13 |
| tradename | New Drug Application | 2014-12-23 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| alzheimer disease | EFO_0000249 | D000544 | F03 |
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
DONEPEZIL HYDROCHLORIDE, ADLARITY, CORIUM | |||
| 2025-03-11 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Donepezil Hydrochloride, Adlarity, Corium | |||
| 10966936 | 2038-08-11 | DP | U-3334 |
| 10835499 | 2038-05-20 | DP | U-3334 |
| 11648214 | 2037-09-23 | DP | U-3334 |
| 9993466 | 2037-07-26 | DP | |
| 10016372 | 2037-07-26 | U-3334 | |
| 10300025 | 2037-07-26 | DP | |
| 10307379 | 2037-07-26 | DP | |
| 11103463 | 2037-07-26 | U-3334 | |
| 11679086 | 2037-05-26 | U-3334 | |
| Donepezil Hydrochloride / Memantine Hydrochloride, Namzaric, Abbvie | |||
| 8058291 | 2029-12-05 | U-1641 | |
| 8039009 | 2029-03-24 | U-1641 | |
| 8168209 | 2025-11-22 | DP | |
| 8173708 | 2025-11-22 | U-1641 | |
| 8283379 | 2025-11-22 | U-1641 | |
| 8293794 | 2025-11-22 | DP | |
| 8329752 | 2025-11-22 | DP | |
| 8338485 | 2025-11-22 | DP | |
| 8338486 | 2025-11-22 | U-1641 | |
| 8362085 | 2025-11-22 | U-1641 | |
| 8580858 | 2025-11-22 | U-1641 | |
| 8598233 | 2025-11-22 | DP | |
| Donepezil Hydrochloride, Aricept, Eisai Inc | |||
| 8481565 | 2026-10-04 | DP | |
HCPCS
No data
Clinical
Clinical Trials
359 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 35 | 48 | 30 | 37 | 42 | 188 |
| Dementia | D003704 | EFO_0003862 | F03 | 4 | 8 | 15 | 11 | 15 | 53 |
| Cognitive dysfunction | D060825 | HP_0001268 | G31.84 | 9 | 13 | 7 | 8 | 8 | 44 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 1 | 5 | 3 | 5 | 3 | 17 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 2 | 2 | 3 | 3 | 2 | 11 |
| Cognition disorders | D003072 | — | — | 1 | 4 | — | 3 | 2 | 9 |
| Lewy body disease | D020961 | EFO_0006792 | G31.83 | — | 2 | 1 | 2 | 4 | 9 |
| Memory disorders | D008569 | — | — | 2 | 1 | 2 | 1 | 2 | 8 |
| Depression | D003863 | — | F33.9 | — | 2 | 2 | 2 | — | 6 |
| Vascular dementia | D015140 | — | F01 | 1 | — | 3 | 1 | 1 | 6 |
Show 39 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Syndrome | D013577 | — | — | 1 | 4 | 4 | — | 1 | 10 |
| Down syndrome | D004314 | EFO_0001064 | Q90 | — | 3 | 2 | — | — | 5 |
| Mixed dementias | D000093902 | — | — | — | — | 1 | — | 2 | 3 |
| Radiation effects | D011830 | — | — | 1 | 1 | 1 | — | — | 3 |
| Rett syndrome | D015518 | Orphanet_778 | F84.2 | — | — | 1 | — | 1 | 2 |
| Anxiety disorders | D001008 | EFO_0006788 | F41.1 | — | 1 | 1 | — | — | 2 |
| Brain injuries | D001930 | — | S06.9 | 1 | 1 | 1 | — | — | 2 |
| Alcoholism | D000437 | EFO_0003829 | F10.1 | — | 2 | 1 | — | — | 2 |
| Alcohol drinking | D000428 | EFO_0004329 | — | — | 2 | 1 | — | — | 2 |
| Ischemic stroke | D000083242 | — | — | — | 1 | 1 | — | — | 2 |
Show 12 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cocaine-related disorders | D019970 | — | F14 | — | 3 | — | — | — | 3 |
| Central nervous system neoplasms | D016543 | — | — | 2 | 1 | — | — | — | 3 |
| Autism spectrum disorder | D000067877 | HP_0000729 | F84.0 | — | 2 | — | — | — | 2 |
| Fragile x syndrome | D005600 | — | Q99.2 | 1 | 1 | — | — | — | 2 |
| Nervous system neoplasms | D009423 | — | — | 1 | 1 | — | — | — | 2 |
| Anorexia | D000855 | HP_0002039 | R63.0 | — | 2 | — | — | — | 2 |
| Anorexia nervosa | D000856 | EFO_0004215 | F50.0 | — | 2 | — | — | — | 2 |
| Consciousness disorders | D003244 | — | — | 1 | 1 | — | — | — | 1 |
| Pervasive child development disorders | D002659 | EFO_0003756 | F84 | — | 1 | — | — | — | 1 |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | — | 1 | — | — | — | 1 |
Show 20 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 31 | — | — | — | 1 | 32 |
| Nervous system diseases | D009422 | — | G00-G99 | 2 | — | — | — | 2 | 4 |
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | 2 | — | — | — | 1 | 3 |
| Malnutrition | D044342 | EFO_0008572 | E40-E46 | 3 | — | — | — | — | 3 |
| Crush injuries | D000071576 | — | T14.8 | 1 | — | — | — | — | 1 |
| Rh isoimmunization | D012203 | EFO_1001159 | — | 1 | — | — | — | — | 1 |
| Neurotoxicity syndromes | D020258 | — | G92 | 1 | — | — | — | — | 1 |
| Visual perception | D014796 | GO_0007601 | — | 1 | — | — | — | — | 1 |
| Attention | D001288 | — | — | 1 | — | — | — | — | 1 |
| Non-neuronal cholinergic system | D000070634 | — | — | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy aging | D000073656 | — | — | — | — | — | — | 2 | 2 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | — | — | — | — | 2 | 2 |
| Neurodegenerative diseases | D019636 | EFO_0005772 | G31.9 | — | — | — | — | 2 | 2 |
| Late onset disorders | D000067562 | — | — | — | — | — | — | 1 | 1 |
| Tauopathies | D024801 | — | — | — | — | — | — | 1 | 1 |
| Hypercholesterolemia | D006937 | HP_0003124 | — | — | — | — | — | 1 | 1 |
| Gait | D005684 | — | — | — | — | — | — | 1 | 1 |
| Diabetes mellitus | D003920 | HP_0000819 | E08-E13 | — | — | — | — | 1 | 1 |
| Gastrointestinal motility | D005769 | — | — | — | — | — | — | 1 | 1 |
| Hypertension | D006973 | EFO_0000537 | I10 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Donepezil |
| INN | donepezil |
| Description | Donepezil is a racemate comprising equimolar amounts of (R)- and (S)-donepezil. A centrally acting reversible acetylcholinesterase inhibitor, its main therapeutic use is in the treatment of Alzheimer's disease where it is used to increase cortical acetylcholine. It has a role as an EC 3.1.1.7 (acetylcholinesterase) inhibitor, a nootropic agent and an EC 3.1.1.8 (cholinesterase) inhibitor. It contains a (R)-donepezil and a (S)-donepezil. It is a conjugate base of a donepezil (1+). |
| Classification | Small molecule |
| Drug class | acetylcholinesterase inhibitors used in the treatment of Alzheimer's disease |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | COc1cc2c(cc1OC)C(=O)C(CC1CCN(Cc3ccccc3)CC1)C2 |
Identifiers
| PDB | — |
| CAS-ID | 120014-06-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL502 |
| ChEBI ID | 53289 |
| PubChem CID | 3152 |
| DrugBank | DB00843 |
| UNII ID | 8SSC91326P (ChemIDplus, GSRS) |
Target
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Variants
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Namzaric – Allergan
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Namzaric – Warner Chilcott
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Aricept – Pfizer
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Estimated US medical usage
Donepezil
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
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Adverse Events
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13,815 adverse events reported
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