asenapine · Hisamitsu · NDA 212268
Secuado
Earliest generic entry, as listed · earliest of 3 marketed strengths
22 Sep 2033
Blocked by patent: US 11813364.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 11813364 | drug product · sets the listed date | 22 Sep 2033 |
| US 10022445 | drug product | 25 Jul 2033 |
| US 10583121 | drug product, use U-2763 | 25 Jul 2033 |
| US 10814002 | drug product, use U-2763 | 25 Jul 2033 |
| US 11123305 | drug product | 25 Jul 2033 |
| US 9687474 | drug product | 25 Jul 2033 |
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 · 3
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 212268 · 001 · RLD | system, transdermal | 3.8MG/24HR | 22 Sep 2033 |
| 212268 · 002 · RLD | system, transdermal | 5.7MG/24HR | 22 Sep 2033 |
| 212268 · 003 · RLD | system, transdermal | 7.6MG/24HR | 22 Sep 2033 |