FDA Orange Book · active-ingredient family
Donepezil hydrochloride
Donepezil hydrochloride: 5 brands, 47 generics; first approved Nov 25, 1996; generic available.
Generic availableHas discontinued products
Generic status & protection
Generic available: 47 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
5
Generics (ANDA)
47
Listed patents
12
Next patent expiry
Oct 04, 2026
in 1 mo
Brand (NDA) products
Originator applications
- ADLARITYRLDCORIUMNDA 21230420222 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/DAY SYSTEM TRANSDERMAL Discontinued — 10MG/DAY SYSTEM TRANSDERMAL Discontinued — - EISAI INCNDA 0225682010
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Rx AB - ARICEPTRLDEISAI INCNDA 0217192004
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG/5ML SOLUTION ORAL Discontinued — - ARICEPT ODTRLDEISAI INCNDA 02172020042 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - ARICEPTRLDEISAI INCNDA 02069019962 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET ORAL Rx AB 5MG TABLET ORAL Rx AB
Generic (ANDA) products (47)
Abbreviated applications
- DONEPEZIL HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 20526920182 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 10MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - DONEPEZIL HYDROCHLORIDECADILA PHARMS LTDANDA 20460920172 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEZYDUS PHARMSANDA 2031622017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEHISUN PHARM HANGZHOUANDA 2024102017
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEUNICHEMANDA 20483120162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEUNICHEMANDA 20365620162 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDECHARTWELL RXANDA 2034192016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEDEXCELANDA 2037132016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEOSMOTICA PHARM USANDA 2031142016
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEACTAVIS ELIZABETHANDA 2024152015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDELUPINANDA 2027822015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDERISINGANDA 2026562015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDESUN PHARMANDA 2042932015
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEHETERO LABS LTD VANDA 20303420152 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDESCIEGEN PHARMSANDA 20390720142 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDETWI PHARMSANDA 2031042014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 2026312014
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEDR REDDYSANDA 2027232013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEPH HEALTHANDA 2025422013
Approved strengths under this FDA application. Strength Dosage form Route Status TE 23MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDERISINGANDA 20211420132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEALEMBIC PHARMS LTDANDA 20172420132 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 20178720122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB 10MG TABLET, ORALLY DISINTEGRATING ORAL Rx AB - DONEPEZIL HYDROCHLORIDEZYDUS LIFESCIENCESANDA 09010020122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEMACLEODS PHARMS LTDANDA 20114620122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEINDICUS PHARMAANDA 20163420122 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEACCORD HLTHCAREANDA 20133520112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEAPOTEXANDA 07884120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEAIPING PHARM INCANDA 09029020112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEAUROBINDOANDA 09005620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDECHARTWELL RXANDA 09042520112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDECIPLA LTDANDA 07751820112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEDR REDDYS LABS LTDANDA 20100120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEHERITAGE PHARMAANDA 07734420112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEHIKMA PHARMSANDA 09024720112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEJUBILANT GENERICSANDA 09076820112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDENATCO PHARMAANDA 09052120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDENOVITIUM PHARMAANDA 09055120112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEPRINSTON INCANDA 20029220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDESTRIDES PHARMAANDA 07866220112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDESUN PHARM INDSANDA 09049320112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDETORRENT PHARMSANDA 09068620112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Rx AB 10MG TABLET ORAL Rx AB - DONEPEZIL HYDROCHLORIDEWOCKHARDTANDA 09126720112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEAIPING PHARM INCANDA 09119820112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - DONEPEZIL HYDROCHLORIDEZYDUS PHARMS USA INCANDA 09017520112 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - DONEPEZIL HYDROCHLORIDECHARTWELL RXANDA 07838820102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — - DONEPEZIL HYDROCHLORIDESUN PHARM INDS LTDANDA 07678620102 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 5MG TABLET ORAL Discontinued — 10MG TABLET ORAL Discontinued — - DONEPEZIL HYDROCHLORIDESUN PHARM INDUSTRIESANDA 07797520092 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued — 5MG TABLET, ORALLY DISINTEGRATING ORAL Discontinued —
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8481565 | in 1 mo | Product | |
| 12161767 | in 10 yr 6 mo | SubstanceProductU-3334 | |
| 12168075 | in 10 yr 6 mo | U-3334 | |
| 11679086 | in 10 yr 11 mo | U-3334 | |
| 11103463 | in 11 yr 1 mo | U-3334 | |
| 10016372 | in 11 yr 1 mo | U-3334 | |
| 10300025 | in 11 yr 1 mo | Product | |
| 10307379 | in 11 yr 1 mo | Product | |
| 9993466 | in 11 yr 1 mo | Product | |
| 11648214 | in 11 yr 3 mo | ProductU-3334 | |
| 10835499 | in 11 yr 11 mo | ProductU-3334 | |
| 10966936 | in 12 yr 2 mo | ProductU-3334 |
Approval history
FDA approval span
First approval
30 yr 2 mo ago
Most recent approval
4 yr 6 mo ago
Approvals span 1996–2022 across 52 FDA applications.
Brand (NDA) 510%
Generic (ANDA) 4790%
Donepezil hydrochloride: frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
Built directly from the FDA Orange Book data file (products, patents, and exclusivity). TE codes, RLD/RS flags, patent expirations, and exclusivity dates match the official FDA record. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Related FDA reference tools
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- 510(k) Predicate DatabaseSearch FDA 510(k) clearances and map predicate-device lineage.
- FDA 483 DatabaseFDA Form 483 observations and inspection records by firm, date, and citation.
