Orange Book product · Brand (NDA)
SAPHRIS
ASENAPINE MALEATE
At a glance
Mar 12, 2015
Approved
Brand (NDA)
Application
AB
TE code
5
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 12, 2015
11 yr 5 mo ago
Patent 7741358 expires
Listed drug substance patent expiration.
Apr 06, 2026
2 mo ago
Patent 7741358 expires
Listed drug substance patent expiration.
Apr 06, 2026
2 mo ago
Patent 8022228 expires
Listed drug substance patent expiration.
Apr 06, 2026
2 mo ago
Today
Patent 7741358*PED expires
Listed listed patent expiration.
Oct 06, 2026
in 4 mo
Patent 8022228*PED expires
Listed listed patent expiration.
Oct 06, 2026
in 4 mo
Pharmaceutical detail
Active ingredient
ASENAPINE MALEATE
Strength
EQ 2.5MG BASE
Dosage form
TABLET
Route
SUBLINGUAL
TE code
AB
Application
NDA 022117
Product number
003
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
No
Active-ingredient family
View full familyThis is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.
Listed patents (5)
| Patent | Expires | In | Type |
|---|---|---|---|
| 7741358 | Apr 06, 2026 | 2 mo ago | SubstanceProductU-1966 |
| 7741358 | Apr 06, 2026 | 2 mo ago | SubstanceProductU-1893 |
| 8022228 | Apr 06, 2026 | 2 mo ago | SubstanceProduct |
| 7741358*PED | Oct 06, 2026 | in 4 mo | |
| 8022228*PED | Oct 06, 2026 | in 4 mo |
