Orange Book product · Brand (NDA)
ZEJULA
NIRAPARIB TOSYLATE
At a glance
Apr 26, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
9
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Apr 26, 2023
3 yr 2 mo ago
Today
Patent 8071579 expires
Listed method-of-use patent (U-2655) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8143241 expires
Listed method-of-use patent (U-2655) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8436185 expires
Listed drug substance patent expiration.
Apr 24, 2029
in 2 yr 11 mo
Patent 8071623 expires
Listed drug substance patent expiration.
Mar 27, 2031
in 4 yr 10 mo
Patent 8859562 expires
Listed method-of-use patent (U-2655) expiration.
Aug 04, 2031
in 5 yr 2 mo
Patent 11091459 expires
Listed drug product patent expiration.
Mar 27, 2038
in 11 yr 11 mo
Patent 11673877 expires
Listed drug product patent expiration.
Mar 27, 2038
in 11 yr 11 mo
Patent 11673877 expires
Listed drug product patent expiration.
Mar 27, 2038
in 11 yr 11 mo
Patent 11730725 expires
Listed drug product patent expiration.
Jan 25, 2039
in 12 yr 9 mo
Pharmaceutical detail
Active ingredient
NIRAPARIB TOSYLATE
Strength
EQ 100MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 214876
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.
Listed patents (9)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8071579 | Aug 12, 2027 | in 1 yr 2 mo | U-2655 |
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-2655 |
| 8436185 | Apr 24, 2029 | in 2 yr 11 mo | Substance |
| 8071623 | Mar 27, 2031 | in 4 yr 10 mo | SubstanceProduct |
| 8859562 | Aug 04, 2031 | in 5 yr 2 mo | U-2655 |
| 11091459 | Mar 27, 2038 | in 11 yr 11 mo | Product |
| 11673877 | Mar 27, 2038 | in 11 yr 11 mo | ProductU-3646 |
| 11673877 | Mar 27, 2038 | in 11 yr 11 mo | ProductU-3647 |
| 11730725 | Jan 25, 2039 | in 12 yr 9 mo | Product |

