FDA Orange Book · active-ingredient family
Abiraterone acetate; niraparib tosylate
Abiraterone acetate; niraparib tosylate is approved in 1 FDA application, with therapeutic-equivalence codes, listed patents, and marketing exclusivity from the FDA Orange Book.
Reference-listed drug:AKEEGA · NDA 216793
1
Brand (NDA)
0
Generics (ANDA)
13
Listed patents
4
Exclusivity periods
Brand (NDA) products · tablet
| Product | Applicant | Application | TE | Approved | |
|---|---|---|---|---|---|
| AKEEGARLD×2 | JANSSEN BIOTECH | NDA 216793 | — | Aug 11, 2023 |
Marketing exclusivity (4)
- I-980New indication exclusivity (3 years)
Dec 12, 2028
in 2 yr 6 mo
- NPNew product exclusivity (3 years)
Aug 11, 2026
in 2 mo
- I-980New indication exclusivity (3 years)
Dec 12, 2028
in 2 yr 6 mo
- NPNew product exclusivity (3 years)
Aug 11, 2026
in 2 mo
Listed patents (13)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8071579 | Aug 12, 2027 | in 1 yr 2 mo | U-2830 |
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-2830 |
| 8436185 | Apr 24, 2029 | in 2 yr 11 mo | SubstanceProduct |
| 8071623 | Mar 27, 2031 | in 4 yr 10 mo | SubstanceProduct |
| 8859562 | Aug 04, 2031 | in 5 yr 2 mo | U-2830 |
| 11986468 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11986469 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11992486 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 12383543 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11986470 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11207311 | Jul 28, 2037 | in 11 yr 3 mo | U-2830 |
| 11673877 | Mar 27, 2038 | in 11 yr 11 mo | SubstanceProductU-2830 |
| 11091459 | Mar 27, 2038 | in 11 yr 11 mo | SubstanceProduct |
Abiraterone acetate; niraparib tosylate — frequently asked questions
Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.
