paliperidone palmitate · Janssen Pharms · NDA 207946
Invega Hafyera
Earliest generic entry, as listed · earliest of 2 marketed strengths
24 Nov 2041
Blocked by patent: US 11666697. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 5 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11666697 | use U-3626 | 24 Nov 2041 |
| US 11304951 | use U-3349 | 7 May 2041 |
| US 11324751 | use U-3359 | 7 May 2041 |
| US 12208100 | use U-4110 | 7 May 2041 |
| US 12208100 | use U-3359 | 7 May 2041 |
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 · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 207946 · 005 · RLD | suspension, extended release, intramuscular | 1.092GM/3.5ML (312MG/ML) | 24 Nov 2041 |
| 207946 · 006 · RLD | suspension, extended release, intramuscular | 1.560GM/5ML (312MG/ML) | 24 Nov 2041 |