Orange Book product · Brand (NDA)
AKEEGA
ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
At a glance
Aug 11, 2023
Approved
Brand (NDA)
Application
Not listed
TE code
22
Listed patents
Key dates
Approval
FDA approval date of this drug product.
Aug 11, 2023
2 yr 11 mo ago
Today
Exclusivity ends · NP
New product exclusivity (3 years)
Aug 11, 2026
in 2 mo
Patent 8071579 expires
Listed method-of-use patent (U-2830) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8071579 expires
Listed method-of-use patent (U-4368) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8143241 expires
Listed method-of-use patent (U-2830) expiration.
Aug 12, 2027
in 1 yr 2 mo
Patent 8143241 expires
Listed method-of-use patent (U-4368) expiration.
Aug 12, 2027
in 1 yr 2 mo
Exclusivity ends · I-980
New indication exclusivity (3 years)
Dec 12, 2028
in 2 yr 6 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-2830) expiration.
Aug 04, 2031
in 5 yr 2 mo
Patent 8859562 expires
Listed method-of-use patent (U-4368) expiration.
Aug 04, 2031
in 5 yr 2 mo
Patent 11207311 expires
Listed method-of-use patent (U-2830) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11207311 expires
Listed method-of-use patent (U-4368) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11986468 expires
Listed method-of-use patent (U-4368) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11986468 expires
Listed method-of-use patent (U-2830) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11986469 expires
Listed method-of-use patent (U-4368) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11986469 expires
Listed method-of-use patent (U-2830) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11986470 expires
Listed method-of-use patent (U-4368) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11992486 expires
Listed method-of-use patent (U-4368) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11992486 expires
Listed method-of-use patent (U-2830) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 12383543 expires
Listed method-of-use patent (U-4368) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 12383543 expires
Listed method-of-use patent (U-2830) expiration.
Jul 28, 2037
in 11 yr 3 mo
Patent 11091459 expires
Listed drug substance patent expiration.
Mar 27, 2038
in 11 yr 11 mo
Patent 11673877 expires
Listed drug substance patent expiration.
Mar 27, 2038
in 11 yr 11 mo
Patent 11673877 expires
Listed drug substance patent expiration.
Mar 27, 2038
in 11 yr 11 mo
Pharmaceutical detail
Active ingredient
ABIRATERONE ACETATE; NIRAPARIB TOSYLATE
Strength
500MG;EQ 50MG BASE
Dosage form
TABLET
Route
ORAL
TE code
Not listed
Application
NDA 216793
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 (2)
- 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
Listed patents (22)
| Patent | Expires | In | Type |
|---|---|---|---|
| 8071579 | Aug 12, 2027 | in 1 yr 2 mo | U-2830 |
| 8071579 | Aug 12, 2027 | in 1 yr 2 mo | U-4368 |
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-2830 |
| 8143241 | Aug 12, 2027 | in 1 yr 2 mo | U-4368 |
| 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 |
| 8859562 | Aug 04, 2031 | in 5 yr 2 mo | U-4368 |
| 11207311 | Jul 28, 2037 | in 11 yr 3 mo | U-2830 |
| 11207311 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11986468 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11986468 | Jul 28, 2037 | in 11 yr 3 mo | U-2830 |
| 11986469 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11986469 | Jul 28, 2037 | in 11 yr 3 mo | U-2830 |
| 11986470 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11992486 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 11992486 | Jul 28, 2037 | in 11 yr 3 mo | U-2830 |
| 12383543 | Jul 28, 2037 | in 11 yr 3 mo | U-4368 |
| 12383543 | Jul 28, 2037 | in 11 yr 3 mo | U-2830 |
| 11091459 | Mar 27, 2038 | in 11 yr 11 mo | SubstanceProduct |
| 11673877 | Mar 27, 2038 | in 11 yr 11 mo | SubstanceProductU-2830 |
| 11673877 | Mar 27, 2038 | in 11 yr 11 mo | SubstanceProductU-4368 |
