Orange Book product · Brand (NDA)
XYOSTED (AUTOINJECTOR)
TESTOSTERONE ENANTHATE
At a glance
Sep 28, 2018
Approved
Brand (NDA)
Application
Not listed
TE code
24
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Sep 28, 2018
7 yr 10 mo ago
Patent 10478560 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Patent 11446441 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Patent 8562564 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Patent 9180259 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Patent 9533102 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Patent 9629959 expires
Listed drug product patent expiration.
Jan 24, 2026
5 mo ago
Today
Patent 8021335 expires
Listed drug product patent expiration.
Oct 04, 2026
in 4 mo
Patent 11497753 expires
Listed drug product patent expiration.
Mar 19, 2030
in 3 yr 10 mo
Patent 10279131 expires
Listed drug product patent expiration.
Jul 31, 2031
in 5 yr 2 mo
Patent 10357609 expires
Listed drug product patent expiration.
Aug 21, 2031
in 5 yr 3 mo
Patent 10905827 expires
Listed drug product patent expiration.
Aug 21, 2031
in 5 yr 3 mo
Patent 11446440 expires
Listed drug product patent expiration.
Aug 21, 2031
in 5 yr 3 mo
Patent 10821072 expires
Listed drug product patent expiration.
Jun 04, 2033
in 7 yr 1 mo
Patent 11844804 expires
Listed method-of-use patent (U-2418) expiration.
Jun 04, 2033
in 7 yr 1 mo
Patent 10881798 expires
Listed drug product patent expiration.
Feb 11, 2034
in 7 yr 9 mo
Patent 11160751 expires
Listed drug product patent expiration.
Oct 07, 2034
in 8 yr 5 mo
Patent 10238662 expires
Listed drug product patent expiration.
Feb 19, 2035
in 8 yr 10 mo
Patent 10912782 expires
Listed drug product patent expiration.
Feb 19, 2035
in 8 yr 10 mo
Patent 11813435 expires
Listed drug product patent expiration.
Feb 25, 2035
in 8 yr 10 mo
Patent 12629483 expires
Listed drug product patent expiration.
Aug 07, 2035
in 9 yr 3 mo
Patent 11191908 expires
Listed drug product patent expiration.
Oct 18, 2035
in 9 yr 6 mo
Patent 9744302 expires
Listed drug product patent expiration.
Nov 19, 2035
in 9 yr 7 mo
Patent 9950125 expires
Listed drug product patent expiration.
Sep 04, 2036
in 10 yr 4 mo
Patent 10646495 expires
Listed drug product patent expiration.
Aug 30, 2038
in 12 yr 5 mo
Pharmaceutical detail
Active ingredient
TESTOSTERONE ENANTHATE
Strength
50MG/0.5ML (50MG/0.5ML)
Dosage form
SOLUTION
Route
SUBCUTANEOUS
TE code
Not listed
Application
NDA 209863
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.
- —DELATESTRYLBrand (NDA)
NDA 009165 · ENDO PHARMS
- 2024TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 212659 · EUGIA PHARMA
- 2012TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 091120 · HIKMA FARMACEUTICA
- 2009TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 040647 · RISING
- 2006TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 040575 · NEXUS
- —TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 083667 · WATSON LABS
- —TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 085599 · WATSON LABS
- —TESTOSTERONE ENANTHATEGeneric (ANDA)
ANDA 085598 · WATSON PHARMS INC
Listed patents (24)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10478560 | Jan 24, 2026 | 5 mo ago | Product |
| 11446441 | Jan 24, 2026 | 5 mo ago | Product |
| 8562564 | Jan 24, 2026 | 5 mo ago | Product |
| 9180259 | Jan 24, 2026 | 5 mo ago | Product |
| 9533102 | Jan 24, 2026 | 5 mo ago | Product |
| 9629959 | Jan 24, 2026 | 5 mo ago | Product |
| 8021335 | Oct 04, 2026 | in 4 mo | Product |
| 11497753 | Mar 19, 2030 | in 3 yr 10 mo | Product |
| 10279131 | Jul 31, 2031 | in 5 yr 2 mo | Product |
| 10357609 | Aug 21, 2031 | in 5 yr 3 mo | Product |
| 10905827 | Aug 21, 2031 | in 5 yr 3 mo | Product |
| 11446440 | Aug 21, 2031 | in 5 yr 3 mo | Product |
| 10821072 | Jun 04, 2033 | in 7 yr 1 mo | ProductU-2418 |
| 11844804 | Jun 04, 2033 | in 7 yr 1 mo | U-2418 |
| 10881798 | Feb 11, 2034 | in 7 yr 9 mo | Product |
| 11160751 | Oct 07, 2034 | in 8 yr 5 mo | ProductU-2418 |
| 10238662 | Feb 19, 2035 | in 8 yr 10 mo | ProductU-2418 |
| 10912782 | Feb 19, 2035 | in 8 yr 10 mo | ProductU-2418 |
| 11813435 | Feb 25, 2035 | in 8 yr 10 mo | Product |
| 12629483 | Aug 07, 2035 | in 9 yr 3 mo | Product |
| 11191908 | Oct 18, 2035 | in 9 yr 6 mo | Product |
| 9744302 | Nov 19, 2035 | in 9 yr 7 mo | Product |
| 9950125 | Sep 04, 2036 | in 10 yr 4 mo | ProductU-2418 |
| 10646495 | Aug 30, 2038 | in 12 yr 5 mo | Product |

