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DONEPEZIL HYDROCHLORIDE
Donepezil Hydrochloride is a marketed drug primarily indicated for dementia of the Alzheimer's type, with a key composition patent expiring in 2028. Its established presence in the Alzheimer's market provides a strong competitive advantage. The primary risk is the potential increase in generic competition following the 2028 patent expiry.
At a glance
| Generic name | DONEPEZIL HYDROCHLORIDE |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1996 |
Approved indications
- Dementia of the Alzheimer's type
Common side effects
- Nausea
- Diarrhea
- Vomiting
- Muscle cramps
- Fatigue
- Anorexia
- Insomnia
- Headache
- Pain, various locations
- Accident
- Syncope
- Frequent Urination
Key clinical trials
- Investigating the Cholinergic Contribution to Gait Dysfunction in Parkinson's Disease (PHASE2)
- Donepezil Versus Non-drug Treatment in Alzheimer's Disease. (PHASE3)
- Ultrasound-Guided Stellate Ganglion Block for Alzheimer's Disease (NA)
- Clinical Evaluation on the Therapeutic Effect of Acupuncture Treatment for Alzheimer's Disease (NA)
- Efficacy and Safety of MK-1167 in Participants With Alzheimer's Disease Dementia Taking Stable Donepezil Treatment (MK-1167-007) (PHASE1)
- Intravenous Infusion of Umbilical Cord Blood as an Adjunctive Treatment for Alzheimer's Disease (EARLY_PHASE1)
- Masitinib in Patients With Mild Alzheimer's Disease (PHASE3)
- Effect of Donepezil on Speech Recognition in Cochlear Implant Users (EARLY_PHASE1)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- DONEPEZIL HYDROCHLORIDE CI brief — competitive landscape report
- DONEPEZIL HYDROCHLORIDE updates RSS · CI watch RSS