aripiprazole lauroxil · Alkermes Inc · NDA 209830
Aristada Initio Kit
Earliest generic entry, as listed
6 Apr 2039
Blocked by patent: US 11273158, US 12251381. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 9 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11273158 | use U-543 | 6 Apr 2039 |
| US 12251381 | use U-543 | 6 Apr 2039 |
| US 10016415 | product | 8 Sep 2035 |
| US 10688091 | product | 17 Aug 2035 |
| US 10849894 | use U-543 | 17 Aug 2035 |
| US 11154552 | product | 17 Aug 2035 |
| US 8431576 | substance | 26 Oct 2030 |
| US 10112903 | substance, use U-543 | 24 Jun 2030 |
| US 8796276 | use U-543 | 24 Jun 2030 |
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 · 1
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 209830 · 001 · RLD | suspension, extended release, intramuscular | 675MG/2.4ML (281.25MG/ML) | 6 Apr 2039 |