TALZENNA — FDA application NDA211651
Listed sponsor: PFIZER · PFE company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE | ORAL | EQ 0.25MG BASE | Discontinued | not listed | Yes |
| 002 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE | ORAL | EQ 1MG BASE | Discontinued | not listed | Yes |
| 003 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE | ORAL | EQ 0.5MG BASE | Discontinued | not listed | Yes |
| 004 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE | ORAL | EQ 0.75MG BASE | Discontinued | not listed | Yes |
| 005 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE | ORAL | EQ 0.1MG BASE | Discontinued | not listed | Yes |
| 006 | TALZENNA | TALAZOPARIB TOSYLATE | CAPSULE | ORAL | EQ 0.35MG BASE | Discontinued | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 10780088 | 001 | listed patent expiry date: 2029-07-27 | U-3651 |
| Patent 10780088 | 003 | listed patent expiry date: 2029-07-27 | U-3651 |
| Patent 10780088 | 005 | listed patent expiry date: 2029-07-27 | U-3651 |
| Patent 10780088 | 006 | listed patent expiry date: 2029-07-27 | U-3651 |
| Patent 8012976 | 001 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8012976 | 002 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8012976 | 003 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8012976 | 004 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8012976 | 005 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8012976 | 006 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8420650 | 001 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8420650 | 002 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8420650 | 003 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8420650 | 004 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8420650 | 005 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 8420650 | 006 | listed patent expiry date: 2029-07-27 | drug substance, drug product |
| Patent 9820985 | 001 | listed patent expiry date: 2029-07-27 | U-2437 |
| Patent 9820985 | 002 | listed patent expiry date: 2029-07-27 | U-2437 |
| Patent 9820985 | 003 | listed patent expiry date: 2029-07-27 | U-2437 |
| Patent 9820985 | 004 | listed patent expiry date: 2029-07-27 | U-2437 |
| Patent 9820985 | 005 | listed patent expiry date: 2029-07-27 | U-2437 |
| Patent 9820985 | 006 | listed patent expiry date: 2029-07-27 | U-2437 |
| Patent 10189837 | 001 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 10189837 | 002 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 10189837 | 003 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 10189837 | 004 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 10189837 | 005 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 10189837 | 006 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 8735392 | 001 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 8735392 | 002 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 8735392 | 003 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 8735392 | 004 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 8735392 | 005 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Patent 8735392 | 006 | listed patent expiry date: 2031-10-20 | drug substance, drug product |
| Exclusivity I-920 | 001 | listed exclusivity date: 2026-06-20 | FDA code as listed |
| Exclusivity I-920 | 003 | listed exclusivity date: 2026-06-20 | FDA code as listed |
| Exclusivity I-920 | 005 | listed exclusivity date: 2026-06-20 | FDA code as listed |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- TALAZOPARIB TOSYLATE · UNII 02WK9U5NZC · lmmol compound QUQKKHBYEFLEHK-QNBGGDODSA-N · CHEMBL3137318
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: Large-cap biopharma
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.