Orange Book product · Brand (NDA)
NEUPRO
ROTIGOTINE
At a glance
Apr 02, 2012
Approved
Brand (NDA)
Application
Not listed
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 02, 2012
14 yr 5 mo ago
Today
Patent 8246979 expires
Listed drug product patent expiration.
Sep 01, 2027
in 1 yr 3 mo
Patent 8246979 expires
Listed drug product patent expiration.
Sep 01, 2027
in 1 yr 3 mo
Patent 10130589 expires
Listed drug product patent expiration.
Dec 22, 2030
in 4 yr 7 mo
Patent 10350174 expires
Listed drug product patent expiration.
Dec 22, 2030
in 4 yr 7 mo
Patent 9925150 expires
Listed drug product patent expiration.
Mar 01, 2032
in 5 yr 9 mo
Pharmaceutical detail
Active ingredient
ROTIGOTINE
Strength
1MG/24HR
Dosage form
FILM, EXTENDED RELEASE
Route
TRANSDERMAL
TE code
Not listed
Application
NDA 021829
Product number
004
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8246979 | Sep 01, 2027 | in 1 yr 3 mo | ProductU-1272 |
| 8246979 | Sep 01, 2027 | in 1 yr 3 mo | ProductU-1273 |
| 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 |
