Orange Book product · Brand (NDA)
TLANDO
TESTOSTERONE UNDECANOATE
At a glance
Mar 28, 2022
Approved
Brand (NDA)
Application
Not listed
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 28, 2022
4 yr 3 mo ago
Today
Patent 11304960 expires
Listed drug product patent expiration.
Jan 08, 2029
in 2 yr 7 mo
Patent 8778922 expires
Listed drug product patent expiration.
Jan 08, 2029
in 2 yr 7 mo
Patent 8865695 expires
Listed method-of-use patent (U-1500) expiration.
Jan 08, 2029
in 2 yr 7 mo
Patent 10226473 expires
Listed method-of-use patent (U-1500) expiration.
Nov 30, 2030
in 4 yr 6 mo
Patent 10716794 expires
Listed method-of-use patent (U-1500) expiration.
Nov 30, 2030
in 4 yr 6 mo
Patent 11311555 expires
Listed method-of-use patent (U-1500) expiration.
Nov 30, 2030
in 4 yr 6 mo
Patent 11364249 expires
Listed method-of-use patent (U-1500) expiration.
Nov 30, 2030
in 4 yr 6 mo
Patent 11433083 expires
Listed method-of-use patent (U-1500) expiration.
Nov 30, 2030
in 4 yr 6 mo
Patent 9943527 expires
Listed method-of-use patent (U-1500) expiration.
Nov 30, 2030
in 4 yr 6 mo
Patent 9949985 expires
Listed method-of-use patent (U-1500) expiration.
Nov 30, 2030
in 4 yr 6 mo
Patent 11559530 expires
Listed method-of-use patent (U-1500) expiration.
Nov 28, 2037
in 11 yr 7 mo
Patent 12310978 expires
Listed method-of-use patent (U-4194) expiration.
Feb 21, 2039
in 12 yr 10 mo
Patent 12011503 expires
Listed drug product patent expiration.
Oct 16, 2040
in 14 yr 6 mo
Patent 12011503 expires
Listed drug product patent expiration.
Oct 16, 2040
in 14 yr 6 mo
Patent 11464735 expires
Listed drug product patent expiration.
Apr 28, 2041
in 15 yr 1 mo
Pharmaceutical detail
Active ingredient
TESTOSTERONE UNDECANOATE
Strength
112.5MG
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 208088
Product number
001
Marketing status
RX
Reference listed drug (RLD)
Yes
Reference standard (RS)
Yes
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 (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11304960 | Jan 08, 2029 | in 2 yr 7 mo | ProductU-1500 |
| 8778922 | Jan 08, 2029 | in 2 yr 7 mo | ProductU-1500 |
| 8865695 | Jan 08, 2029 | in 2 yr 7 mo | U-1500 |
| 10226473 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 10716794 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 11311555 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 11364249 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 11433083 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 9943527 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 9949985 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 11559530 | Nov 28, 2037 | in 11 yr 7 mo | U-1500 |
| 12310978 | Feb 21, 2039 | in 12 yr 10 mo | U-4194 |
| 12011503 | Oct 16, 2040 | in 14 yr 6 mo | ProductU-3964 |
| 12011503 | Oct 16, 2040 | in 14 yr 6 mo | ProductU-3965 |
| 11464735 | Apr 28, 2041 | in 15 yr 1 mo | ProductU-1500 |
