Orange Book product · Brand (NDA)
XTANDI
ENZALUTAMIDE
At a glance
Aug 04, 2020
Approved
Brand (NDA)
Application
AB
TE code
15
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 04, 2020
6 yr ago
Patent 9126941 expires
Listed method-of-use patent (U-2708) expiration.
May 15, 2026
1 mo ago
Patent 9126941 expires
Listed method-of-use patent (U-2345) expiration.
May 15, 2026
1 mo ago
Patent 9126941 expires
Listed method-of-use patent (U-3763) expiration.
May 15, 2026
1 mo ago
Today
Patent 8183274 expires
Listed method-of-use patent (U-2345) expiration.
Aug 24, 2026
in 2 mo
Patent 8183274 expires
Listed method-of-use patent (U-2708) expiration.
Aug 24, 2026
in 2 mo
Patent 8183274 expires
Listed method-of-use patent (U-3763) expiration.
Aug 24, 2026
in 2 mo
Exclusivity ends · I-926
New indication exclusivity (3 years)
Nov 17, 2026
in 5 mo
Patent 7709517 expires
Listed drug substance patent expiration.
Aug 13, 2027
in 1 yr 2 mo
Patent 11839689 expires
Listed drug product patent expiration.
Sep 11, 2033
in 7 yr 4 mo
Patent 12502357 expires
Listed method-of-use patent (U-4363) expiration.
Sep 11, 2033
in 7 yr 4 mo
Patent 12502357 expires
Listed method-of-use patent (U-4364) expiration.
Sep 11, 2033
in 7 yr 4 mo
Patent 12502357 expires
Listed method-of-use patent (U-4365) expiration.
Sep 11, 2033
in 7 yr 4 mo
Patent 12161628 expires
Listed method-of-use patent (U-4101) expiration.
Feb 23, 2037
in 10 yr 10 mo
Patent 12161628 expires
Listed method-of-use patent (U-4102) expiration.
Feb 23, 2037
in 10 yr 10 mo
Patent 12161628 expires
Listed method-of-use patent (U-4103) expiration.
Feb 23, 2037
in 10 yr 10 mo
Patent 12161628 expires
Listed method-of-use patent (U-4104) expiration.
Feb 23, 2037
in 10 yr 10 mo
Pharmaceutical detail
Active ingredient
ENZALUTAMIDE
Strength
40MG
Dosage form
TABLET
Route
ORAL
TE code
AB
Application
NDA 213674
Product number
001
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.
Marketing exclusivity (1)
- I-926New indication exclusivity (3 years)
Nov 17, 2026
in 5 mo
Listed patents (15)
| Patent | Expires | In | Type |
|---|---|---|---|
| 9126941 | May 15, 2026 | 1 mo ago | U-2708 |
| 9126941 | May 15, 2026 | 1 mo ago | U-2345 |
| 9126941 | May 15, 2026 | 1 mo ago | U-3763 |
| 8183274 | Aug 24, 2026 | in 2 mo | U-2345 |
| 8183274 | Aug 24, 2026 | in 2 mo | U-2708 |
| 8183274 | Aug 24, 2026 | in 2 mo | U-3763 |
| 7709517 | Aug 13, 2027 | in 1 yr 2 mo | SubstanceProduct |
| 11839689 | Sep 11, 2033 | in 7 yr 4 mo | Product |
| 12502357 | Sep 11, 2033 | in 7 yr 4 mo | U-4363 |
| 12502357 | Sep 11, 2033 | in 7 yr 4 mo | U-4364 |
| 12502357 | Sep 11, 2033 | in 7 yr 4 mo | U-4365 |
| 12161628 | Feb 23, 2037 | in 10 yr 10 mo | U-4101 |
| 12161628 | Feb 23, 2037 | in 10 yr 10 mo | U-4102 |
| 12161628 | Feb 23, 2037 | in 10 yr 10 mo | U-4103 |
| 12161628 | Feb 23, 2037 | in 10 yr 10 mo | U-4104 |
