rotigotine · Ucb Inc · NDA 021829
Neupro
Earliest generic entry, as listed · earliest of 6 marketed strengths
1 Mar 2032
Blocked by patent: US 9925150.
Listed patents · 4 unexpired
5 Orange Book listing rows for 4 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 9925150 | drug product · sets the listed date | 1 Mar 2032 |
| US 10130589 | drug product | 22 Dec 2030 |
| US 10350174 | drug product | 22 Dec 2030 |
| US 8246979 | drug product, use U-1272, U-1273 | 1 Sep 2027 |
| US 8246979 listing row | drug product, use U-1272 | 1 Sep 2027 |
| US 8246979 listing row | drug product, use U-1273 | 1 Sep 2027 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 021829 · 001 · RLD | film, extended release, transdermal | 2MG/24HR | 1 Mar 2032 |
| 021829 · 002 · RLD | film, extended release, transdermal | 4MG/24HR | 1 Mar 2032 |
| 021829 · 003 · RLD | film, extended release, transdermal | 6MG/24HR | 1 Mar 2032 |
| 021829 · 004 · RLD | film, extended release, transdermal | 1MG/24HR | 1 Mar 2032 |
| 021829 · 005 · RLD | film, extended release, transdermal | 3MG/24HR | 1 Mar 2032 |
| 021829 · 006 · RLD | film, extended release, transdermal | 8MG/24HR | 1 Mar 2032 |