FDA Orange Book · active-ingredient family
Asenapine
Asenapine is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:SECUADO · NDA 212268
1
Brand (NDA)
0
Generics (ANDA)
6
Listed patents
0
Exclusivity periods
Brand (NDA) products · system
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| SECUADORLD×3 | HISAMITSU | NDA 212268 | — | Oct 11, 2019 |
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10583121 | Jul 25, 2033 | in 7 yr 2 mo | ProductU-2763 |
| 10814002 | Jul 25, 2033 | in 7 yr 2 mo | ProductU-2763 |
| 10022445 | Jul 25, 2033 | in 7 yr 2 mo | Product |
| 11123305 | Jul 25, 2033 | in 7 yr 2 mo | Product |
| 9687474 | Jul 25, 2033 | in 7 yr 2 mo | Product |
| 11813364 | Sep 22, 2033 | in 7 yr 4 mo | Product |
Asenapine — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
