FDA Orange Book · active-ingredient family
Donepezil hydrochloride; memantine hydrochloride
Donepezil hydrochloride; memantine hydrochloride is approved as 1 brand and 4 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:NAMZARIC · NDA 206439
1
Brand (NDA)
4
Generics (ANDA)
3
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NAMZARICRLD×4 | ABBVIE | NDA 206439 | AB | Jul 18, 2016 |
Generic (ANDA) products (4)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE×2 | MACLEODS PHARMS LTD | ANDA 208672 | AB | Jul 15, 2025 | |
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE×2 | XIAMEN LP PHARM CO | ANDA 216901 | AB | Jul 15, 2025 | |
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE×4 | AMNEAL | ANDA 208328 | AB | Feb 27, 2025 | |
| MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE | ANI PHARMS | ANDA 208237 | AB | Dec 15, 2023 |
Listed patents (3)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8039009 | Mar 24, 2029 | in 2 yr 10 mo | U-1641 |
| 8039009*PED | Sep 24, 2029 | in 3 yr 4 mo | |
| 8058291 | Dec 05, 2029 | in 3 yr 6 mo | U-1641 |
Donepezil hydrochloride; memantine hydrochloride — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
