DONEPEZIL HYDROCHLORIDE generics — when can they launch?
DONEPEZIL HYDROCHLORIDE (DONEPEZIL HYDROCHLORIDE) · · 35 active US patents · 0 expired
Where DONEPEZIL HYDROCHLORIDE sits in the generic timeline
All listed Orange Book patents for DONEPEZIL HYDROCHLORIDE have expired. Generic entry is permitted, and ANDA filers can launch without patent infringement risk. Hatch-Waxman exclusivity (NCE/ODE/PED) may still apply if recently approved.
Under US Hatch-Waxman, a generic enters via an ANDA (Abbreviated New Drug Application) and may file with one of four Paragraph IV certifications attacking the brand's listed patents. If the brand sues within 45 days, a 30-month FDA approval stay is triggered. First Para IV filer typically gets 180-day market exclusivity.
Patent estate by type — active patents
Method-of-use patents only carve out specific indications; generics can launch with a "skinny label" omitting those uses. Composition-of-matter patents block the molecule itself.
- Method of Use — 24 patents
- Formulation — 7 patents
- Other — 4 patents
FDA U-codes carved out by DONEPEZIL HYDROCHLORIDE patents
Method-of-use patents are listed against specific FDA Patent Use Codes ("U-codes") representing carved-out indications. Generics can launch with a label that omits these uses.
| U-code | Description |
|---|---|
U-1641 | (no description) |
U-3334 | (no description) |
Sample patent estate
Showing 6 of 35 active US patents. View full estate on the DONEPEZIL HYDROCHLORIDE drug page →
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This patent protects a method for stabilizing an anti-dementia drug, specifically donepezil hydrochloride, in a pharmaceutical composition.USPTO title: Method for stabilizing anti-dementia drug
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This patent protects modified release formulations of memantine oral dosage forms that sustain the release of the active agent for 4 to 24 hours.USPTO title: Modified release formulations of memantine oral dosage forms
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This patent protects modified release formulations of memantine oral dosage forms that sustain the release of the active agent for 4 to 24 hours.USPTO title: Modified release formulations of memantine oral dosage forms
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This patent protects modified release formulations of memantine oral dosage forms that sustain the release of the active agent for 4 to 24 hours.USPTO title: Modified release formulations of memantine oral dosage forms
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This patent protects modified release formulations of memantine oral dosage forms that sustain the release of the active agent for 4 to 24 hours.USPTO title: Modified release formulations of memantine oral dosage forms
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This patent protects pharmaceutical compositions containing memantine or a memantine salt, sustained-release formulations that release the active agent over 4 to 24 hours.USPTO title: Modified release formulations of memantine oral dosage forms
Sources
- FDA Orange Book — patents listed against DONEPEZIL HYDROCHLORIDE (NDA filed 1996)
- DONEPEZIL HYDROCHLORIDE drug profile — full patent estate, indications, clinical trials, pricing
- Patent cliff 2026 — every drug losing US exclusivity that year
Patent term extensions (PTR, pediatric exclusivity), Hatch-Waxman 30-month stays, and FDA regulatory exclusivity (NCE/ODE/PED) may shift the effective generic entry date. Not legal advice.
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