Orange Book product · Brand (NDA)

NAMZARIC

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Brand (NDA)NDA 206439TE ABRX ABBVIE

Jul 18, 2016

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 18, 2016
10 yr 1 mo ago
Today
Patent 8039009 expires
Listed method-of-use patent (U-1641) expiration.
Mar 24, 2029
in 2 yr 10 mo
Patent 8039009*PED expires
Listed listed patent expiration.
Sep 24, 2029
in 3 yr 4 mo
Patent 8058291 expires
Listed method-of-use patent (U-1641) expiration.
Dec 05, 2029
in 3 yr 6 mo

Active ingredient

DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE

Strength

10MG;21MG

Dosage form

CAPSULE, EXTENDED RELEASE

Route

ORAL

TE code

Application

NDA 206439

Product number

004

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
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