aripiprazole · Otsuka Pharm Co Ltd · NDA 202971
Abilify Maintena Kit
Earliest generic entry, as listed · earliest of 4 marketed strengths
1 Apr 2041
Blocked by patent: US 12691056. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 7 unexpired
17 Orange Book listing rows for 7 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12691056 | use U-3245, U-814 | 1 Apr 2041 |
| US 12691056 listing row | use U-3245 · sets the listed date | 1 Apr 2041 |
| US 12691056 listing row | use U-814 · sets the listed date | 1 Apr 2041 |
| US 11648347 | drug product | 6 Apr 2034 |
| US 10525057 | use U-1632, U-2723, U-543 | 8 Mar 2034 |
| US 10525057 listing row | use U-1632 | 8 Mar 2034 |
| US 10525057 listing row | use U-2723 | 8 Mar 2034 |
| US 10525057 listing row | use U-543 | 8 Mar 2034 |
| US 10980803 | use U-1632, U-543 | 24 Sep 2033 |
| US 10980803 listing row | use U-1632 | 24 Sep 2033 |
| US 10980803 listing row | use U-543 | 24 Sep 2033 |
| US 11154553 | use U-1632, U-3245, U-814 | 24 Sep 2033 |
| US 11154553 listing row | use U-1632 | 24 Sep 2033 |
| US 11154553 listing row | use U-3245 | 24 Sep 2033 |
| US 11154553 listing row | use U-814 | 24 Sep 2033 |
| US 11344547 | use U-1632, U-3245, U-814 | 24 Sep 2033 |
| US 11344547 listing row | use U-1632 | 24 Sep 2033 |
| US 11344547 listing row | use U-3245 | 24 Sep 2033 |
| US 11344547 listing row | use U-814 | 24 Sep 2033 |
| US 11400087 | use U-1632, U-3245, U-814 | 24 Sep 2033 |
| US 11400087 listing row | use U-1632 | 24 Sep 2033 |
| US 11400087 listing row | use U-3245 | 24 Sep 2033 |
| US 11400087 listing row | use U-814 | 24 Sep 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 202971 · 001 · RLD | for suspension, extended release, intramuscular | 300MG/VIAL | 1 Apr 2041 |
| 202971 · 002 · RLD | for suspension, extended release, intramuscular | 400MG/VIAL | 1 Apr 2041 |
| 202971 · 003 · RLD | for suspension, extended release, intramuscular | 300MG | 1 Apr 2041 |
| 202971 · 004 · RLD | for suspension, extended release, intramuscular | 400MG | 1 Apr 2041 |