paliperidone palmitate · Luye Innomind Pharma · NDA 216352
Erzofri
Earliest generic entry, as listed · earliest of 6 marketed strengths
24 Sep 2039
Blocked by patent: US 11666573, US 11666573. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 4 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11666573 | use U-3968 | 24 Sep 2039 |
| US 11666573 | use U-3969 | 24 Sep 2039 |
| US 12128049 | use U-3968 | 26 Oct 2038 |
| US 12128049 | use U-3969 | 26 Oct 2038 |
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 · 6
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216352 · 001 · RLD | suspension, extended release, intramuscular | 39MG/0.25ML (39MG/0.25ML) | 24 Sep 2039 |
| 216352 · 002 · RLD | suspension, extended release, intramuscular | 78MG/0.5ML (78MG/0.5ML) | 24 Sep 2039 |
| 216352 · 003 · RLD | suspension, extended release, intramuscular | 117MG/0.75ML (117MG/0.75ML) | 24 Sep 2039 |
| 216352 · 004 · RLD | suspension, extended release, intramuscular | 156MG/ML (156MG/ML) | 24 Sep 2039 |
| 216352 · 005 · RLD | suspension, extended release, intramuscular | 234MG/1.5ML (156MG/ML) | 24 Sep 2039 |
| 216352 · 006 · RLD | suspension, extended release, intramuscular | 351MG/2.25ML (156MG/ML) | 24 Sep 2039 |