Orange Book product · Brand (NDA)
TALZENNA
TALAZOPARIB TOSYLATE
At a glance
Mar 07, 2024
Approved
Brand (NDA)
Application
Not listed
TE code
6
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Mar 07, 2024
2 yr 4 mo ago
Today
Exclusivity ends · I-920
New indication exclusivity (3 years)
Jun 20, 2026
in 1 d
Patent 10780088 expires
Listed method-of-use patent (U-3651) expiration.
Jul 27, 2029
in 3 yr 2 mo
Patent 8012976 expires
Listed drug substance patent expiration.
Jul 27, 2029
in 3 yr 2 mo
Patent 8420650 expires
Listed drug substance patent expiration.
Jul 27, 2029
in 3 yr 2 mo
Patent 9820985 expires
Listed method-of-use patent (U-2437) expiration.
Jul 27, 2029
in 3 yr 2 mo
Patent 10189837 expires
Listed drug substance patent expiration.
Oct 20, 2031
in 5 yr 5 mo
Patent 8735392 expires
Listed drug substance patent expiration.
Oct 20, 2031
in 5 yr 5 mo
Pharmaceutical detail
Active ingredient
TALAZOPARIB TOSYLATE
Strength
EQ 0.5MG BASE
Dosage form
CAPSULE
Route
ORAL
TE code
Not listed
Application
NDA 217439
Product number
004
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-920New indication exclusivity (3 years)
Jun 20, 2026
in 1 d
Listed patents (6)
| Patent | Expires | In | Type |
|---|---|---|---|
| 10780088 | Jul 27, 2029 | in 3 yr 2 mo | U-3651 |
| 8012976 | Jul 27, 2029 | in 3 yr 2 mo | SubstanceProduct |
| 8420650 | Jul 27, 2029 | in 3 yr 2 mo | SubstanceProduct |
| 9820985 | Jul 27, 2029 | in 3 yr 2 mo | U-2437 |
| 10189837 | Oct 20, 2031 | in 5 yr 5 mo | SubstanceProduct |
| 8735392 | Oct 20, 2031 | in 5 yr 5 mo | SubstanceProduct |
