FDA Orange Book · active-ingredient family
Rotigotine
Rotigotine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:NEUPRO · NDA 021829
1
Brand (NDA)
0
Generics (ANDA)
4
Listed patents
0
Exclusivity periods
Brand (NDA) products · film, extended release
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| NEUPRORLD×6 | UCB INC | NDA 021829 | — | Apr 02, 2012 |
Listed patents (4)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8246979 | Sep 01, 2027 | in 1 yr 3 mo | ProductU-1272 |
| 10130589 | Dec 22, 2030 | in 4 yr 7 mo | Product |
| 10350174 | Dec 22, 2030 | in 4 yr 7 mo | Product |
| 9925150 | Mar 01, 2032 | in 5 yr 9 mo | Product |
Rotigotine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
