FDA Orange Book · active-ingredient family
Testosterone undecanoate
Testosterone undecanoate is approved in 4 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:KYZATREX · NDA 213953
4
Brand (NDA)
0
Generics (ANDA)
33
Listed patents
0
Exclusivity periods
Brand (NDA) products · capsule, injectable
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| KYZATREXRLD×3 | MARIUS | NDA 213953 | — | Jul 27, 2022 | |
| TLANDORLD | VERITY | NDA 208088 | — | Mar 28, 2022 | |
| JATENZORLD×3 | TOLMAR | NDA 206089 | — | Mar 27, 2019 | |
| AVEEDRLD | ENDO OPERATIONS | NDA 022219 | — | Mar 05, 2014 |
Listed patents (33)
| Patent | Expires | In | Type |
|---|---|---|---|
| 11179402 | Apr 14, 2026 | 2 mo ago | SubstanceProduct |
| 11331325 | Jan 06, 2027 | in 7 mo | U-2506 |
| 7718640 | Mar 14, 2027 | in 9 mo | Product |
| 8338395 | May 08, 2027 | in 11 mo | U-1500 |
| 11304960 | Jan 08, 2029 | in 2 yr 7 mo | ProductU-1500 |
| 8865695 | Jan 08, 2029 | in 2 yr 7 mo | U-1500 |
| 8778922 | Jan 08, 2029 | in 2 yr 7 mo | ProductU-1500 |
| 8241664 | Mar 29, 2029 | in 2 yr 10 mo | ProductU-2506 |
| 10543219 | Apr 12, 2030 | in 3 yr 10 mo | U-2506 |
| 11179403 | Apr 12, 2030 | in 3 yr 10 mo | U-2506 |
| 11426416 | Apr 12, 2030 | in 3 yr 10 mo | U-3420 |
| 10617696 | Apr 12, 2030 | in 3 yr 10 mo | SubstanceProduct |
| 8778916 | Apr 12, 2030 | in 3 yr 10 mo | Product |
| 11433083 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 11364249 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 10716794 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 9949985 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 11311555 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 10226473 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 9943527 | Nov 30, 2030 | in 4 yr 6 mo | U-1500 |
| 8492369 | Dec 20, 2030 | in 4 yr 7 mo | ProductU-2506 |
| 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 |
| 11559530 | Nov 28, 2037 | in 11 yr 7 mo | U-1500 |
| 12310978 | Feb 21, 2039 | in 12 yr 10 mo | U-4194 |
| 11564933 | Apr 12, 2039 | in 13 yr | U-1103 |
| 12605391 | Apr 12, 2039 | in 13 yr | U-1103 |
| 12011503 | Oct 16, 2040 | in 14 yr 6 mo | ProductU-3964 |
| 12403146 | Mar 29, 2041 | in 15 yr | ProductU-2506 |
| 11464735 | Apr 28, 2041 | in 15 yr 1 mo | ProductU-1500 |
Testosterone undecanoate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
