Orange Book product · Brand (NDA)
KYZATREX
TESTOSTERONE UNDECANOATE
At a glance
Jul 27, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Jul 27, 2022
3 yr 11 mo ago
Today
Patent 10576089 expires
Listed drug product patent expiration.
Dec 31, 2030
in 4 yr 7 mo
Patent 10576090 expires
Listed drug product patent expiration.
Dec 31, 2030
in 4 yr 7 mo
Patent 11590146 expires
Listed drug product patent expiration.
Dec 31, 2030
in 4 yr 7 mo
Patent 11617758 expires
Listed drug product patent expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 12357643 expires
Listed drug product patent expiration.
Mar 15, 2033
in 6 yr 10 mo
Patent 12403146 expires
Listed drug product patent expiration.
Mar 29, 2041
in 15 yr
Pharmaceutical detail
Active ingredient
TESTOSTERONE UNDECANOATE
Strength
100MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 213953
Product number
001
Marketing status
DISCN
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 (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10576089 | Dec 31, 2030 | in 4 yr 7 mo | ProductU-2506 |
| 10576090 | Dec 31, 2030 | in 4 yr 7 mo | Product |
| 11590146 | Dec 31, 2030 | in 4 yr 7 mo | Product |
| 11617758 | Mar 15, 2033 | in 6 yr 10 mo | ProductU-2506 |
| 12357643 | Mar 15, 2033 | in 6 yr 10 mo | ProductU-2506 |
| 12403146 | Mar 29, 2041 | in 15 yr | ProductU-2506 |
