niraparib tosylate · Glaxosmithkline · NDA 208447, 214876
Zejula
Earliest generic entry, as listed · earliest of 3 marketed strengths
25 Jan 2039
Blocked by patent: US 11730725.
Listed patents · 8 unexpired
9 Orange Book listing rows for 8 patents. FDA lists a patent once for each use code, and lists its pediatric extension as a separate row.
| Patent | Claims | Expires |
|---|---|---|
| US 11730725 | drug product · sets the listed date | 25 Jan 2039 |
| US 11091459 | drug product | 27 Mar 2038 |
| US 11673877 | drug product, use U-3646, U-3647 | 27 Mar 2038 |
| US 11673877 listing row | drug product, use U-3646 | 27 Mar 2038 |
| US 11673877 listing row | drug product, use U-3647 | 27 Mar 2038 |
| US 8859562 | use U-2655 | 4 Aug 2031 |
| US 8071623 | drug substance, drug product | 27 Mar 2031 |
| US 8436185 | drug substance | 24 Apr 2029 |
| US 8071579 | use U-2655 | 12 Aug 2027 |
| US 8143241 | use U-2655 | 12 Aug 2027 |
Exclusivities · 1 unexpired
| ODE-295 | orphan drug (7 years) | 29 Apr 2027 |
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 · 4
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 208447 · 001 · RLD · discontinued | capsule, oral | EQ 100MG BASE | 27 Mar 2038 |
| 214876 · 001 · RLD | tablet, oral | EQ 100MG BASE | 25 Jan 2039 |
| 214876 · 002 · RLD | tablet, oral | EQ 200MG BASE | 25 Jan 2039 |
| 214876 · 003 · RLD | tablet, oral | EQ 300MG BASE | 25 Jan 2039 |
Expired or delisted (1)
- ODE-277 · 23 Oct 2026