FDA Orange Book · active-ingredient family
Niraparib tosylate
Niraparib tosylate is approved in 2 FDA applications, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:ZEJULA · NDA 214876
2
Brand (NDA)
0
Generics (ANDA)
8
Listed patents
2
Exclusivity periods
Brand (NDA) products · capsule, tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| ZEJULARLD×3 | GLAXOSMITHKLINE | NDA 214876 | — | Apr 26, 2023 | |
| ZEJULARLD | GLAXOSMITHKLINE | NDA 208447 | — | Mar 27, 2017 |
Marketing exclusivity (2)
- ODE-277Orphan-drug exclusivity (7 years)
Oct 23, 2026
in 4 mo
- ODE-295Orphan-drug exclusivity (7 years)
Apr 29, 2027
in 10 mo
Listed patents (8)
| 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 |
| 11673877 | Mar 27, 2038 | in 11 yr 11 mo | ProductU-3646 |
| 11091459 | Mar 27, 2038 | in 11 yr 11 mo | Product |
| 11730725 | Jan 25, 2039 | in 12 yr 9 mo | Product |
Niraparib tosylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
