aripiprazole lauroxil · Alkermes Inc · NDA 207533
Aristada
Earliest generic entry, as listed · earliest of 4 marketed strengths
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 · 18 unexpired
19 Orange Book listing rows for 18 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11273158 | use U-543 · sets the listed date | 6 Apr 2039 |
| US 12251381 | use U-543 · sets the listed date | 6 Apr 2039 |
| US 10238651 | use U-2402 | 19 Mar 2035 |
| US 10813928 | use U-2402, U-2983 | 19 Mar 2035 |
| US 10813928 listing row | use U-2402 | 19 Mar 2035 |
| US 10813928 listing row | use U-2983 | 19 Mar 2035 |
| US 11406632 | use U-2402 | 19 Mar 2035 |
| US 12653822 | use U-2402 | 19 Mar 2035 |
| US 9452131 | use U-2402 | 19 Mar 2035 |
| US 9526726 | drug product | 19 Mar 2035 |
| US 11969469 | drug product | 6 Apr 2034 |
| US 9193685 | drug product, use U-543 | 24 Oct 2033 |
| US 11097006 | drug product, use U-764 | 19 Sep 2033 |
| US 12311027 | drug product, use U-543 | 19 Sep 2033 |
| US 12629366 | drug product, use U-764 | 6 Dec 2032 |
| US 9034867 | drug product, use U-543 | 7 Nov 2032 |
| US 10226458 | use U-543 | 19 Mar 2032 |
| US 8431576 | drug substance | 26 Oct 2030 |
| US 10112903 | drug 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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207533 · 001 · RLD | suspension, extended release, intramuscular | 441MG/1.6ML (275.63MG/ML) | 6 Apr 2039 |
| 207533 · 002 · RLD | suspension, extended release, intramuscular | 662MG/2.4ML (275.83MG/ML) | 6 Apr 2039 |
| 207533 · 003 · RLD | suspension, extended release, intramuscular | 882MG/3.2ML (275.63MG/ML) | 6 Apr 2039 |
| 207533 · 004 · RLD | suspension, extended release, intramuscular | 1064MG/3.9ML (272.82MG/ML) | 6 Apr 2039 |