Orange Book product · Brand (NDA)
JATENZO
TESTOSTERONE UNDECANOATE
At a glance
Mar 27, 2019
Approved
Brand (NDA)
Application
Not listed
TE code
11
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 27, 2019
7 yr 4 mo ago
Patent 11179402 expires
Listed drug substance patent expiration.
Apr 14, 2026
2 mo ago
Today
Patent 11331325 expires
Listed method-of-use patent (U-2506) expiration.
Jan 06, 2027
in 7 mo
Patent 8241664 expires
Listed drug product patent expiration.
Mar 29, 2029
in 2 yr 10 mo
Patent 10543219 expires
Listed method-of-use patent (U-2506) expiration.
Apr 12, 2030
in 3 yr 10 mo
Patent 10617696 expires
Listed drug substance patent expiration.
Apr 12, 2030
in 3 yr 10 mo
Patent 11179403 expires
Listed method-of-use patent (U-2506) expiration.
Apr 12, 2030
in 3 yr 10 mo
Patent 11426416 expires
Listed method-of-use patent (U-3420) expiration.
Apr 12, 2030
in 3 yr 10 mo
Patent 8778916 expires
Listed drug product patent expiration.
Apr 12, 2030
in 3 yr 10 mo
Patent 8492369 expires
Listed drug product patent expiration.
Dec 20, 2030
in 4 yr 7 mo
Patent 11564933 expires
Listed method-of-use patent (U-1103) expiration.
Apr 12, 2039
in 13 yr
Patent 12605391 expires
Listed method-of-use patent (U-1103) expiration.
Apr 12, 2039
in 13 yr
Pharmaceutical detail
Active ingredient
TESTOSTERONE UNDECANOATE
Strength
198MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 206089
Product number
002
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 (11)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11179402 | Apr 14, 2026 | 2 mo ago | SubstanceProduct |
| 11331325 | Jan 06, 2027 | in 7 mo | U-2506 |
| 8241664 | Mar 29, 2029 | in 2 yr 10 mo | ProductU-2506 |
| 10543219 | Apr 12, 2030 | in 3 yr 10 mo | U-2506 |
| 10617696 | Apr 12, 2030 | in 3 yr 10 mo | SubstanceProduct |
| 11179403 | Apr 12, 2030 | in 3 yr 10 mo | U-2506 |
| 11426416 | Apr 12, 2030 | in 3 yr 10 mo | U-3420 |
| 8778916 | Apr 12, 2030 | in 3 yr 10 mo | Product |
| 8492369 | Dec 20, 2030 | in 4 yr 7 mo | ProductU-2506 |
| 11564933 | Apr 12, 2039 | in 13 yr | U-1103 |
| 12605391 | Apr 12, 2039 | in 13 yr | U-1103 |
