FDA Orange Book · active-ingredient family
Rivastigmine
Rivastigmine is approved as 1 brand and 6 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EXELON · NDA 022083
1
Brand (NDA)
6
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXELONRLD×3 | SANDOZ | NDA 022083 | AB | Jul 06, 2007 |
Generic (ANDA) products (6)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIVASTIGMINE×3 | YICHANG HUMANWELL | ANDA 215445 | AB | Sep 23, 2025 | |
| RIVASTIGMINE×3 | BRECKENRIDGE | ANDA 209063 | AB | Nov 26, 2019 | |
| RIVASTIGMINE×3 | ZYDUS PHARMS | ANDA 206318 | AB | Mar 04, 2019 | |
| RIVASTIGMINE×3 | AMNEAL PHARMS | ANDA 207308 | AB | Jan 08, 2019 | |
| RIVASTIGMINE×3 | MYLAN TECHNOLOGIES | ANDA 205622 | AB | Jun 20, 2018 | |
| RIVASTIGMINE×3 | ALVOGEN | ANDA 204403 | — | Sep 03, 2015 |
Listed patents
No patents are listed against this product in the Orange Book. Listed patents reflect those the NDA holder submits under 21 U.S.C. 355 and are not exhaustive.
Rivastigmine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
