# TALZENNA — FDA application NDA211651

Informational only - not investment advice.

Application NDA211651 · type NDA · FDA status: approved · original approval 2018-10-16

Listed sponsor: PFIZER · [PFE company profile](/company/PFE/) · 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 |

## Orange Book patent and exclusivity listings

- Patent 10780088, product 001; listed patent expiry date: 2029-07-27.
- Patent 10780088, product 003; listed patent expiry date: 2029-07-27.
- Patent 10780088, product 005; listed patent expiry date: 2029-07-27.
- Patent 10780088, product 006; listed patent expiry date: 2029-07-27.
- Patent 8012976, product 001; listed patent expiry date: 2029-07-27.
- Patent 8012976, product 002; listed patent expiry date: 2029-07-27.
- Patent 8012976, product 003; listed patent expiry date: 2029-07-27.
- Patent 8012976, product 004; listed patent expiry date: 2029-07-27.
- Patent 8012976, product 005; listed patent expiry date: 2029-07-27.
- Patent 8012976, product 006; listed patent expiry date: 2029-07-27.
- Patent 8420650, product 001; listed patent expiry date: 2029-07-27.
- Patent 8420650, product 002; listed patent expiry date: 2029-07-27.
- Patent 8420650, product 003; listed patent expiry date: 2029-07-27.
- Patent 8420650, product 004; listed patent expiry date: 2029-07-27.
- Patent 8420650, product 005; listed patent expiry date: 2029-07-27.
- Patent 8420650, product 006; listed patent expiry date: 2029-07-27.
- Patent 9820985, product 001; listed patent expiry date: 2029-07-27.
- Patent 9820985, product 002; listed patent expiry date: 2029-07-27.
- Patent 9820985, product 003; listed patent expiry date: 2029-07-27.
- Patent 9820985, product 004; listed patent expiry date: 2029-07-27.
- Patent 9820985, product 005; listed patent expiry date: 2029-07-27.
- Patent 9820985, product 006; listed patent expiry date: 2029-07-27.
- Patent 10189837, product 001; listed patent expiry date: 2031-10-20.
- Patent 10189837, product 002; listed patent expiry date: 2031-10-20.
- Patent 10189837, product 003; listed patent expiry date: 2031-10-20.
- Patent 10189837, product 004; listed patent expiry date: 2031-10-20.
- Patent 10189837, product 005; listed patent expiry date: 2031-10-20.
- Patent 10189837, product 006; listed patent expiry date: 2031-10-20.
- Patent 8735392, product 001; listed patent expiry date: 2031-10-20.
- Patent 8735392, product 002; listed patent expiry date: 2031-10-20.
- Patent 8735392, product 003; listed patent expiry date: 2031-10-20.
- Patent 8735392, product 004; listed patent expiry date: 2031-10-20.
- Patent 8735392, product 005; listed patent expiry date: 2031-10-20.
- Patent 8735392, product 006; listed patent expiry date: 2031-10-20.
- Exclusivity I-920, product 001; listed exclusivity date: 2026-06-20.
- Exclusivity I-920, product 003; listed exclusivity date: 2026-06-20.
- Exclusivity I-920, product 005; listed exclusivity date: 2026-06-20.

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](https://lmmol.com/compound/QUQKKHBYEFLEHK-QNBGGDODSA-N)

Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.

## Related pages

- [Sponsor company](/company/PFE/)
- [FDA-approved application index](/drug/)
- [Large-cap biopharma](/compare/pharma/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA211651. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.