FDA Orange Book · active-ingredient family
Rivastigmine tartrate
Rivastigmine tartrate is approved as 2 brand and 10 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.
Reference-listed drug:EXELON · NDA 020823
2
Brand (NDA)
10
Generics (ANDA)
0
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, solution
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| EXELONRLD×4 | NOVARTIS | NDA 020823 | — | Apr 21, 2000 | |
| EXELONRLD | NOVARTIS | NDA 021025 | — | Apr 21, 2000 |
Generic (ANDA) products (10)
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| RIVASTIGMINE TARTRATE×4 | CHARTWELL RX | ANDA 207797 | AB | Sep 28, 2017 | |
| RIVASTIGMINE TARTRATE×4 | CADILA PHARMS LTD | ANDA 203844 | AB | Feb 13, 2017 | |
| RIVASTIGMINE TARTRATE×4 | AUROBINDO PHARMA | ANDA 204572 | AB | Mar 25, 2016 | |
| RIVASTIGMINE TARTRATE×4 | ORBION PHARMS | ANDA 090879 | AB | Jun 10, 2015 | |
| RIVASTIGMINE TARTRATE×4 | MACLEODS PHARMS LTD | ANDA 203148 | AB | Aug 22, 2014 | |
| RIVASTIGMINE TARTRATE×4 | APOTEX INC | ANDA 091072 | — | May 16, 2013 | |
| RIVASTIGMINE TARTRATE×4 | ALEMBIC PHARMS LTD | ANDA 091689 | AB | Jun 12, 2012 | |
| RIVASTIGMINE TARTRATE×4 | WATSON LABS | ANDA 077129 | AB | Jan 08, 2008 | |
| RIVASTIGMINE TARTRATE×4 | DR REDDYS LABS INC | ANDA 077130 | AB | Oct 31, 2007 | |
| RIVASTIGMINE TARTRATE×4 | SUN PHARM | ANDA 077131 | — | Oct 22, 2007 |
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 tartrate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
