talazoparib tosylate · Pfizer · NDA 211651, 217439
Talzenna
Earliest generic entry, as listed · earliest of 6 marketed strengths
16 Oct 2032
Blocked by patent: US 8012976.
Listed patents · 6 unexpired
| Patent | Claims | Expires |
|---|---|---|
| US 8012976 | drug substance, drug product · sets the listed date | 16 Oct 2032 |
| US 10189837 | drug substance, drug product | 20 Oct 2031 |
| US 8735392 | drug substance, drug product | 20 Oct 2031 |
| US 10780088 | use U-3651 | 27 Jul 2029 |
| US 8420650 | drug substance, drug product | 27 Jul 2029 |
| US 9820985 | use U-2437 | 27 Jul 2029 |
Exclusivities · 0 unexpired
No unexpired exclusivities listed.
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 · 12
| NDA · product | Form | Strength | Listed expiry |
|---|---|---|---|
| 211651 · 001 · RLD · discontinued | capsule, oral | EQ 0.25MG BASE | 16 Oct 2032 |
| 211651 · 002 · RLD · discontinued | capsule, oral | EQ 1MG BASE | 16 Oct 2032 |
| 211651 · 003 · RLD · discontinued | capsule, oral | EQ 0.5MG BASE | 16 Oct 2032 |
| 211651 · 004 · RLD · discontinued | capsule, oral | EQ 0.75MG BASE | 16 Oct 2032 |
| 211651 · 005 · RLD · discontinued | capsule, oral | EQ 0.1MG BASE | 16 Oct 2032 |
| 211651 · 006 · RLD · discontinued | capsule, oral | EQ 0.35MG BASE | 16 Oct 2032 |
| 217439 · 001 · RLD | capsule, oral | EQ 0.1MG BASE | 16 Oct 2032 |
| 217439 · 002 · RLD | capsule, oral | EQ 0.25MG BASE | 16 Oct 2032 |
| 217439 · 003 · RLD | capsule, oral | EQ 0.35MG BASE | 16 Oct 2032 |
| 217439 · 004 · RLD | capsule, oral | EQ 0.5MG BASE | 16 Oct 2032 |
| 217439 · 005 · RLD | capsule, oral | EQ 0.75MG BASE | 16 Oct 2032 |
| 217439 · 006 · RLD | capsule, oral | EQ 1MG BASE | 16 Oct 2032 |
Expired or delisted (1)
- I-920 · 20 Jun 2026