naltrexone · Alkermes · NDA 021897
Vivitrol
Earliest generic entry, as listed
15 Oct 2029
Blocked by patent: US 7919499. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 1 unexpired
2 Orange Book listing rows for 1 patent. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 7919499 | use U-1123, U-1124 | 15 Oct 2029 |
| US 7919499 listing row | use U-1123 · sets the listed date | 15 Oct 2029 |
| US 7919499 listing row | use U-1124 · sets the listed date | 15 Oct 2029 |
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 |
|---|---|---|---|
| 021897 · 001 · RLD | for suspension, extended release, intramuscular | 380MG/VIAL | 15 Oct 2029 |