FDA Orange Book
Is there a generic for Talzenna?
Talzenna contains talazoparib. Orange Book status for every listed strength, the approved generic makers, and the listed patents and exclusivities.
Source: FDA Orange Book data file dated 2026-10-09. Publisher page
No. The Orange Book lists no active FDA-approved generic (ANDA) for Talzenna (talazoparib). The Orange Book shows its last listed patent expires October 16, 2032 and its last listed exclusivity ends June 20, 2026.
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Talzenna products in the Orange Book
| Form and route | Strength | Brand status | Brand TE | Active generics | Generic TE codes |
|---|---|---|---|---|---|
| capsule, oral | EQ 0.1MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.1MG BASE | Discontinued | None | 0 | None |
| capsule, oral | EQ 0.25MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.25MG BASE | Discontinued | None | 0 | None |
| capsule, oral | EQ 0.35MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.35MG BASE | Discontinued | None | 0 | None |
| capsule, oral | EQ 0.5MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.5MG BASE | Discontinued | None | 0 | None |
| capsule, oral | EQ 0.75MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 0.75MG BASE | Discontinued | None | 0 | None |
| capsule, oral | EQ 1MG BASE | Marketed (Rx) | None | 0 | None |
| capsule, oral | EQ 1MG BASE | Discontinued | None | 0 | None |
NDA 217439, 211651, held by PFIZER INC. Active generics are ANDA products in the Orange Book prescription list with the same ingredient, dosage form, route and strength.
Talzenna patents
| Patent | Expires | Covers | Use code | NDA |
|---|---|---|---|---|
| 9820985 | July 27, 2029 | Method of use | U-2437 | 211651 |
| 10780088 | July 27, 2029 | Method of use | U-3651 | 211651 |
| 8420650 | July 27, 2029 | Drug substance, Drug product | None | 211651 |
| 10189837 | October 20, 2031 | Drug substance, Drug product | None | 211651 |
| 8735392 | October 20, 2031 | Drug substance, Drug product | None | 211651 |
| 8012976 | October 16, 2032 | Drug substance, Drug product | None | 211651 |
Talzenna exclusivity
| Code | Meaning | Expires | NDA |
|---|---|---|---|
| I-920 | New indication | June 20, 2026 | 211651 |
Talzenna NDC codes
Questions
Is there a generic for Talzenna?
No. The Orange Book lists no active FDA-approved generic (ANDA) for Talzenna (talazoparib). The Orange Book shows its last listed patent expires October 16, 2032 and its last listed exclusivity ends June 20, 2026.
What is the generic name for Talzenna?
The active ingredient in Talzenna is talazoparib, per the FDA Orange Book.
When does the Talzenna patent expire?
The last patent listed for Talzenna in the Orange Book expires October 16, 2032. A listed patent expiry date is not a generic launch date.
What does a therapeutic equivalence code mean?
In the Orange Book, codes that start with A (such as AB) mean FDA considers the product therapeutically equivalent to the reference drug. Codes that start with B mean FDA does not, at this time, consider the product therapeutically equivalent.