paliperidone palmitate · Janssen Pharms · NDA 022264
Invega Sustenna
Earliest generic entry, as listed · earliest of 5 marketed strengths
26 Jan 2031
Blocked by patent: US 9439906. 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 9439906 | use U-2757, U-2758 | 26 Jan 2031 |
| US 9439906 listing row | use U-2757 · sets the listed date | 26 Jan 2031 |
| US 9439906 listing row | use U-2758 · sets the listed date | 26 Jan 2031 |
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 · 5
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 022264 · 001 · RLD | suspension, extended release, intramuscular | 39MG/0.25ML (39MG/0.25ML) | 26 Jan 2031 |
| 022264 · 002 · RLD | suspension, extended release, intramuscular | 78MG/0.5ML (78MG/0.5ML) | 26 Jan 2031 |
| 022264 · 003 · RLD | suspension, extended release, intramuscular | 117MG/0.75ML (117MG/0.75ML) | 26 Jan 2031 |
| 022264 · 004 · RLD | suspension, extended release, intramuscular | 156MG/ML (156MG/ML) | 26 Jan 2031 |
| 022264 · 005 · RLD | suspension, extended release, intramuscular | 234MG/1.5ML (156MG/ML) | 26 Jan 2031 |