aripiprazole · Otsuka · NDA 217006
Abilify Asimtufii
Earliest generic entry, as listed · earliest of 2 marketed strengths
23 Apr 2033
Blocked by patent: US 10517951, US 11097007, US 11638757, US 12016927.
Listed patents · 4 unexpired
8 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 10517951 | drug product, use U-3245, U-814 | 23 Apr 2033 |
| US 10517951 listing row | drug product, use U-3245 · sets the listed date | 23 Apr 2033 |
| US 10517951 listing row | drug product, use U-814 · sets the listed date | 23 Apr 2033 |
| US 11097007 | drug product, use U-3245, U-814 | 23 Apr 2033 |
| US 11097007 listing row | drug product, use U-3245 · sets the listed date | 23 Apr 2033 |
| US 11097007 listing row | drug product, use U-814 · sets the listed date | 23 Apr 2033 |
| US 11638757 | drug product, use U-3245, U-814 | 23 Apr 2033 |
| US 11638757 listing row | drug product, use U-3245 · sets the listed date | 23 Apr 2033 |
| US 11638757 listing row | drug product, use U-814 · sets the listed date | 23 Apr 2033 |
| US 12016927 | drug product, use U-3245, U-543 | 23 Apr 2033 |
| US 12016927 listing row | drug product, use U-3245 · sets the listed date | 23 Apr 2033 |
| US 12016927 listing row | drug product, use U-543 · sets the listed date | 23 Apr 2033 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 217006 · 001 · RLD | suspension, extended release, intramuscular | 720MG/2.4ML (300MG/ML) | 23 Apr 2033 |
| 217006 · 002 · RLD | suspension, extended release, intramuscular | 960MG/3.2ML (300MG/ML) | 23 Apr 2033 |