abiraterone acetate; niraparib tosylate · Janssen Biotech · NDA 216793
Akeega
Earliest generic entry, as listed · earliest of 2 marketed strengths
30 Sep 2043
Blocked by patent: US 12734180. Only method-of-use patents remain, so a generic may carve out the protected indication and enter earlier.
Listed patents · 14 unexpired
24 Orange Book listing rows for 14 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 12734180 | use U-4608, U-4609 | 30 Sep 2043 |
| US 12734180 listing row | use U-4608 · sets the listed date | 30 Sep 2043 |
| US 12734180 listing row | use U-4609 · sets the listed date | 30 Sep 2043 |
| US 11091459 | drug substance, drug product | 27 Mar 2038 |
| US 11673877 | drug substance, drug product, use U-2830, U-4368 | 27 Mar 2038 |
| US 11673877 listing row | drug substance, drug product, use U-2830 | 27 Mar 2038 |
| US 11673877 listing row | drug substance, drug product, use U-4368 | 27 Mar 2038 |
| US 11207311 | use U-2830, U-4368 | 28 Jul 2037 |
| US 11207311 listing row | use U-2830 | 28 Jul 2037 |
| US 11207311 listing row | use U-4368 | 28 Jul 2037 |
| US 11986468 | use U-2830, U-4368 | 28 Jul 2037 |
| US 11986468 listing row | use U-2830 | 28 Jul 2037 |
| US 11986468 listing row | use U-4368 | 28 Jul 2037 |
| US 11986469 | use U-2830, U-4368 | 28 Jul 2037 |
| US 11986469 listing row | use U-2830 | 28 Jul 2037 |
| US 11986469 listing row | use U-4368 | 28 Jul 2037 |
| US 11986470 | use U-4368 | 28 Jul 2037 |
| US 11992486 | use U-2830, U-4368 | 28 Jul 2037 |
| US 11992486 listing row | use U-2830 | 28 Jul 2037 |
| US 11992486 listing row | use U-4368 | 28 Jul 2037 |
| US 12383543 | use U-2830, U-4368 | 28 Jul 2037 |
| US 12383543 listing row | use U-2830 | 28 Jul 2037 |
| US 12383543 listing row | use U-4368 | 28 Jul 2037 |
| US 8859562 | use U-2830, U-4368 | 4 Aug 2031 |
| US 8859562 listing row | use U-2830 | 4 Aug 2031 |
| US 8859562 listing row | use U-4368 | 4 Aug 2031 |
| US 8071623 | drug substance, drug product | 27 Mar 2031 |
| US 8436185 | drug substance, drug product | 24 Apr 2029 |
| US 8071579 | use U-2830, U-4368 | 12 Aug 2027 |
| US 8071579 listing row | use U-2830 | 12 Aug 2027 |
| US 8071579 listing row | use U-4368 | 12 Aug 2027 |
| US 8143241 | use U-2830, U-4368 | 12 Aug 2027 |
| US 8143241 listing row | use U-2830 | 12 Aug 2027 |
| US 8143241 listing row | use U-4368 | 12 Aug 2027 |
Exclusivities · 1 unexpired
| I-980 | new indication (3 years) | 12 Dec 2028 |
Paragraph IV certifications · 0
No Paragraph IV certification listed by FDA for this drug.
The list shows that a generic applicant certified to FDA that a listed patent is invalid or not infringed. It does not show litigation, settlements or launch timing.
Event history
No events yet. The first ingestion only records products entering their 12-month window; changes appear from the next Orange Book update.
Products covered · 2
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 216793 · 001 · RLD | tablet, oral | 500MG;EQ 50MG BASE | 30 Sep 2043 |
| 216793 · 002 · RLD | tablet, oral | 500MG;EQ 100MG BASE | 30 Sep 2043 |
Expired or delisted (1)
- NP · 11 Aug 2026