Prescription medicine
Niraparib Brand names: Zejula
Niraparib (Zejula) is a prescription medicine with an FDA approval on record since 2017. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the niraparib FDA label on DailyMed (effective July 28, 2026, GlaxoSmithKline LLC); the NDA 208447 record on Drugs@FDA; every niraparib label on DailyMed.
Highlights of the record
FDA label of July 28, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspec
Forms and strengths
- 100 mg
- 200 mg
- 300 mg
Film-coated tablet.
On the market
- Earliest approval on file
- March 27, 2017 Zejula, Glaxosmithkline; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- January 25, 2039 Zejula tablets; 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
- 22,065 through July 30, 2026
What is niraparib used for?
From the label: indications and usageZEJULA is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated:
for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to first-line platinum-based chemotherapy and whose cancer is associated with homologous recombination deficiency (HRD)-positive status defined by either: o a deleterious or suspected deleterious BRCA mutation, and/or o genomic instability. Select patients for therapy based on an FDA‑authorized companion diagnostic for ZEJULA. […]
FDA pharmacologic class: Poly(ADP-Ribose) Polymerase Inhibitor.
Source: FDA drug label (ZEJULA), GlaxoSmithKline LLC, effective July 28, 2026 (SPL set b7f675e2-159c-490c-b6f4-3f16d9492b7d), via openFDA; the full label on DailyMed
What does the patient leaflet for niraparib 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 ZEJULA?ZEJULA may cause serious side effects including: • Bone marrow problems called myelodysplastic syndrome (MDS) or a type of cancer of the blood called acute myeloid leukemia (AML). Some people who have ovarian cancer and who have received previous treatment with chemotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with ZEJULA. MDS or AML may lead to death. If you develop MDS or AML, your healthcare provider will stop treatment with ZEJULA. Symptoms of low blood cell counts (low red blood cells, low white blood cells, and low platelets) are common during treatment with ZEJULA, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include: o weakness o feeling tired o weight loss o frequent infections o fever o shortness of breath o blood in urine or stool o bruising or bleeding more easily Your healthcare provider will do blood tests to check your blood cell counts: o before treatment with ZEJULA. o weekly for the first month of treatment with ZEJULA. o every month for the next 11 months, then as needed during treatment with ZEJULA. • High blood pressure. High blood pressure is common during treatment with ZEJULA and can become serious. Your healthcare provider will check your blood pressure and heart rate at least weekly for the first 2 months, then monthly for the first year and as needed thereafter during your treatment with ZEJULA. • Posterior reversible encephalopathy syndrome (PRES). PRES is a condition that affects the brain and may happen during treatment with ZEJULA. If you have headache, vision changes, confusion, or seizure with or without high blood pressure, please contact your healthcare provider. […]
From the patient leaflet: How should I store ZEJULA?Store ZEJULA at room temperature between 68°F to 77°F (20°C to 25°C). • Store ZEJULA tablets in the original bottle. Keep ZEJULA and all medicines out of the reach of children.
Source: FDA drug label (ZEJULA), GlaxoSmithKline LLC, effective July 28, 2026 (SPL set b7f675e2-159c-490c-b6f4-3f16d9492b7d), via openFDA; the full label on DailyMed
Is there a generic for niraparib (Zejula)?
No generic niraparib is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Zejula tablets: the compound patent runs to March 27, 2031, and the last listed entry to January 25, 2039. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2017 earliest approval on file
- 2039 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for niraparib?
The FDA Adverse Event Reporting System holds 22,065 reports that list niraparib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 1,428 are coded as a death and 5,041 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 next?
- Other poly(adp-ribose) polymerase inhibitors
- the pharmacologic class, with prices and generics
- Niraparib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other