FDA Orange Book
Is there a generic for Akeega?
Akeega contains niraparib and abiraterone acetate. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Akeega (niraparib and abiraterone acetate). The Orange Book shows its last listed patent expires September 30, 2043 and its last listed exclusivity ends December 12, 2028.
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Akeega products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| tablet, oral | 500MG;EQ 100MG BASE | Marketed (Rx) | None | 0 | None |
| tablet, oral | 500MG;EQ 50MG BASE | Marketed (Rx) | None | 0 | None |
NDA 216793, held by JANSSEN BIOTECH INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Akeega patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 8071579 | August 12, 2027 | Method of use | U-2830 | 216793 |
| 8143241 | August 12, 2027 | Method of use | U-2830 | 216793 |
| 8143241 | August 12, 2027 | Method of use | U-4368 | 216793 |
| 8071579 | August 12, 2027 | Method of use | U-4368 | 216793 |
| 8436185 | April 24, 2029 | Drug substance, Drug product | None | 216793 |
| 8071623 | March 27, 2031 | Drug substance, Drug product | None | 216793 |
| 8859562 | August 4, 2031 | Method of use | U-2830 | 216793 |
| 8859562 | August 4, 2031 | Method of use | U-4368 | 216793 |
| 11986468 | July 28, 2037 | Method of use | U-4368 | 216793 |
| 11986469 | July 28, 2037 | Method of use | U-4368 | 216793 |
| 11992486 | July 28, 2037 | Method of use | U-4368 | 216793 |
| 12383543 | July 28, 2037 | Method of use | U-4368 | 216793 |
| 11986470 | July 28, 2037 | Method of use | U-4368 | 216793 |
| 11992486 | July 28, 2037 | Method of use | U-2830 | 216793 |
| 11986469 | July 28, 2037 | Method of use | U-2830 | 216793 |
| 11986468 | July 28, 2037 | Method of use | U-2830 | 216793 |
| 11207311 | July 28, 2037 | Method of use | U-2830 | 216793 |
| 12383543 | July 28, 2037 | Method of use | U-2830 | 216793 |
| 11207311 | July 28, 2037 | Method of use | U-4368 | 216793 |
| 11673877 | March 27, 2038 | Drug substance, Drug product | U-2830 | 216793 |
| 11673877 | March 27, 2038 | Drug substance, Drug product | U-4368 | 216793 |
| 11091459 | March 27, 2038 | Drug substance, Drug product | None | 216793 |
| 12734180 | September 30, 2043 | Method of use | U-4608 | 216793 |
| 12734180 | September 30, 2043 | Method of use | U-4609 | 216793 |
Akeega exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| NP | New product | August 11, 2026 | 216793 |
| I-980 | New indication | December 12, 2028 | 216793 |
Akeega NDC codes
Questions
Is there a generic for Akeega?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Akeega (niraparib and abiraterone acetate). The Orange Book shows its last listed patent expires September 30, 2043 and its last listed exclusivity ends December 12, 2028.
What is the generic name for Akeega?
The active ingredient in Akeega is niraparib and abiraterone acetate, per the FDA Orange Book.
When does the Akeega patent expire?
The last patent listed for Akeega in the Orange Book expires September 30, 2043. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.