FDA Orange Book · active-ingredient family
Donepezil hydrochloride; memantine hydrochloride
Donepezil hydrochloride; memantine hydrochloride: 1 brand, 4 generics; first approved Dec 23, 2014; generic available.
Generic available
Generic status & protection
Generic available: 4 ANDA applications approved.
Earliest patent expiry
Brands (NDA)
1
Generics (ANDA)
4
Listed patents
3
Next patent expiry
Mar 24, 2029
in 2 yr 7 mo
Brand (NDA) products
Originator applications
- NAMZARICRLDABBVIENDA 20643920164 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG;28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG;7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG;21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB
Generic (ANDA) products (4)
Abbreviated applications
- MACLEODS PHARMS LTDANDA 20867220252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG;28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - XIAMEN LP PHARM COANDA 21690120252 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG;28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - AMNEALANDA 20832820254 strengths
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;14MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG;28MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG;7MG CAPSULE, EXTENDED RELEASE ORAL Rx AB 10MG;21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB - ANI PHARMSANDA 2082372023
Approved strengths under this FDA application. Strength Dosage form Route Status TE 10MG;21MG CAPSULE, EXTENDED RELEASE ORAL Rx AB
Patent & exclusivity timeline
Protection horizon
Patent expiryExclusivity endToday
Listed patents
Orange Book patent file
| Patent | Expires | In | Type |
|---|---|---|---|
| 8039009 | in 2 yr 7 mo | U-1641 | |
| 8039009*PED | in 3 yr 1 mo | ||
| 8058291 | in 3 yr 4 mo | U-1641 |
Approval history
FDA approval span
First approval
11 yr 11 mo ago
Most recent approval
1 yr 2 mo ago
Approvals span 2014–2025 across 5 FDA applications.
Brand (NDA) 120%
Generic (ANDA) 480%
Donepezil hydrochloride; memantine 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
- FDA Purple BookLicensed biologics, biosimilars, interchangeables, BLA records, and exclusivity dates.
- FDA BiosimilarsFDA-approved biosimilars and interchangeable biosimilars, by reference product.
- 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.
