Prescription medicine
Talazoparib Brand names: Talzenna
Talazoparib (Talzenna) is a prescription medicine with an FDA approval on record since 2018. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the talazoparib FDA label on DailyMed (effective April 10, 2026, Pfizer Laboratories Div Pfizer Inc); the NDA 211651 record on Drugs@FDA; every talazoparib label on DailyMed.
Highlights of the record
FDA label of April 10, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageTALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer
As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer.
Forms and strengths
- 0.1 mg
- 0.25 mg
- 0.35 mg
- 0.5 mg
- 0.75 mg
- 1 mg
Liquid-filled capsule; capsule.
On the market
- Earliest approval on file
- October 16, 2018 Talzenna, Pfizer; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- October 20, 2031 Talzenna capsules; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,763 through July 30, 2026
What is talazoparib used for?
From the label: indications and usageTALZENNA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated for: Breast Cancer
As a single agent, for the treatment of adult patients with deleterious or suspected deleterious germline BRCA -mutated (g BRCA m) HER2-negative locally advanced or metastatic breast cancer. Select patients for therapy based on an FDA-approved companion diagnostic for TALZENNA. ( 1.1 ) HRR Gene-mutated Metastatic Castration-Resistant Prostate Cancer (mCRPC)
In combination with enzalutamide for the treatment of adult patients with HRR gene-mutated metastatic castration-resistant prostate cancer (mCRPC). […]
Conditions named in the indications of talazoparib's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Poly(ADP-Ribose) Polymerase Inhibitor.
Source: FDA drug label (Talzenna), Pfizer Laboratories Div Pfizer Inc, effective April 10, 2026 (SPL set c6fd147f-a77e-4a0b-9280-e82ecc41b4be), via openFDA; the full label on DailyMed
What does the patient leaflet for talazoparib say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about TALZENNA?TALZENNA may cause serious side effects, including: • Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during or after treatment with TALZENNA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with TALZENNA. Symptoms of low blood cell counts are common during treatment with TALZENNA, but can be a sign of serious problems, including MDS or AML. Tell your healthcare provider if you have any of the following symptoms during treatment with TALZENNA: ○ weakness ○ weight loss ○ fever ○ frequent infections ○ blood in urine or stool ○ shortness of breath ○ feeling very tired ○ bruising or bleeding more easily Your healthcare provider will do blood tests to check your blood cell counts: ○ every month during treatment with TALZENNA. ○ weekly if you have low blood cell counts that last a long time. Your healthcare provider may change your dose, temporarily stop, or permanently stop treatment with TALZENNA if you get certain side effects. See “ What are the possible side effects of TALZENNA? ” below for other side effects of TALZENNA.
From the patient leaflet: How should I store TALZENNA?Store TALZENNA at 68°F to 77°F (20°C to 25°C). Keep TALZENNA and all medicines out of the reach of children.
Source: FDA drug label (Talzenna), Pfizer Laboratories Div Pfizer Inc, effective April 10, 2026 (SPL set c6fd147f-a77e-4a0b-9280-e82ecc41b4be), via openFDA; the full label on DailyMed
Is there a generic for talazoparib (Talzenna)?
No generic talazoparib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 6 patents for Talzenna capsules: the compound patent runs to October 20, 2031. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2018 earliest approval on file
- 2031 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the talazoparib label say about other medicines?
The talazoparib label names 6 other medicines in its interaction, contraindication or warning sections. The labels of 1 other medicine name talazoparib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | Drugs on TALZENNA Effect of P-gp Inhibitors Breast Cancer Avoid coadministration of TALZENNA with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. |
| Carvedilol | drug interactions | Drugs on TALZENNA Effect of P-gp Inhibitors Breast Cancer Avoid coadministration of TALZENNA with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. |
| Clarithromycin | drug interactions | Drugs on TALZENNA Effect of P-gp Inhibitors Breast Cancer Avoid coadministration of TALZENNA with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. |
| Enzalutamide | drug interactions | HRR Gene-mutated mCRPC The effect of coadministration of P-gp inhibitors on talazoparib exposure when TALZENNA is taken with enzalutamide has not been studied. |
| Itraconazole | drug interactions | Drugs on TALZENNA Effect of P-gp Inhibitors Breast Cancer Avoid coadministration of TALZENNA with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. |
| Verapamil | drug interactions | Drugs on TALZENNA Effect of P-gp Inhibitors Breast Cancer Avoid coadministration of TALZENNA with the following P-gp inhibitors: itraconazole, amiodarone, carvedilol, clarithromycin, itraconazole, and verapamil. |
Source: FDA drug label (Talzenna), Pfizer Laboratories Div Pfizer Inc, effective April 10, 2026 (SPL set c6fd147f-a77e-4a0b-9280-e82ecc41b4be), via openFDA; the full label on DailyMed
What do FAERS reports show for talazoparib?
The FDA Adverse Event Reporting System holds 1,763 reports that list talazoparib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 328 are coded as a death and 614 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as talazoparib?
19 other medicines are given the same way (oral) and in the same FDA class as talazoparib or labeled mainly for the same use (breast cancer), the same class first. Breast cancer lists all 44 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Olaparib | Breast cancer, Prostate cancer | none listed | n/a | No current entry |
| Rucaparib camsylate | Prostate cancer | none listed | n/a | No current entry |
| Abiraterone and niraparib | Prostate cancer | none listed | n/a | No current entry |
| Everolimus | Breast cancer | 14 labelers | $26.32 per tablet 10 mg tablet | A presentation being discontinued |
| Anastrozole | Breast cancer | 24 labelers | $0.142 per tablet 1 mg tablet | No current entry |
| Letrozole | Breast cancer | 19 labelers | $0.145 per tablet 2.5 mg tablet | No current entry |
| Tamoxifen | Breast cancer | 10 labelers | $0.277 per tablet 20 mg tablet | No current entry |
| Exemestane | Breast cancer | 10 labelers | $0.748 per tablet 25 mg tablet | No current entry |
Every medicine labeled for the same conditions as talazoparib
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to talazoparib
- 19 medicines for the same use
- Other poly(adp-ribose) polymerase inhibitors
- the pharmacologic class, with prices and generics
- Talazoparib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other