Prescription medicine
Olaparib Brand names: Lynparza
Olaparib (Lynparza) is a prescription medicine with an FDA approval on record since 2014. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the olaparib FDA label on DailyMed (effective July 10, 2025, AstraZeneca Pharmaceuticals LP); the NDA 206162 record on Drugs@FDA; every olaparib label on DailyMed.
Highlights of the record
FDA label of July 10, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageLynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer
for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy.
Forms and strengths
- 100 mg
- 150 mg
Film-coated tablet.
On the market
- Earliest approval on file
- December 19, 2014 Lynparza, Astrazeneca; Drugs@FDA’s file, where older or withdrawn approvals can be missing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
- October 25, 2041 Lynparza 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
- 20,798 through July 30, 2026
What is olaparib used for?
From the label: indications and usageLynparza is a poly (ADP-ribose) polymerase (PARP) inhibitor indicated: Ovarian cancer
for the maintenance treatment of adult patients with deleterious or suspected deleterious germline or somatic BRCA -mutated advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy. Select patients for therapy based on an FDA-approved companion diagnostic for Lynparza. […]
Conditions named in the indications of olaparib's FDA labels, with every medicine labeled for each:
From other olaparib labelsBreast cancer: for the treatment of adult patients with deleterious or suspected deleterious gBRCA m, HER2-negative metastatic breast cancer who have been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting.
Prostate cancer: Treatment of BRCA -mutated Metastatic Castration-Resistant Prostate Cancer in Combination with Abiraterone and Prednisone or Prednisolone Lynparza is indicated in combination with abiraterone and prednisone or prednisolone for the …
FDA pharmacologic class: Poly(ADP-Ribose) Polymerase Inhibitor.
Source: FDA drug label (Lynparza), AstraZeneca Pharmaceuticals LP, effective July 10, 2025 (SPL set 741ff3e3-dc1a-45a6-84e5-2481b27131aa), via openFDA; the full label on DailyMed
What does the patient leaflet for olaparib 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 Lynparza?Lynparza may cause serious side effects, including: • Bone marrow problems called Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML). Some people who have received previous treatment with chemotherapy, radiotherapy or certain other medicines for their cancer have developed MDS or AML during treatment with Lynparza. MDS or AML may lead to death. Symptoms of low blood cell counts are common during treatment with Lynparza, but can be a sign of serious bone marrow problems, including MDS or AML. Symptoms may include: ∘ 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: ∘ before treatment with Lynparza ∘ every month during treatment with Lynparza ∘ weekly if you have low blood cell counts that last a long time. • Lung problems (Pneumonitis). Lynparza can cause serious lung problems that can lead to death. Tell your healthcare provider if you have any new or worsening symptoms of lung problems, including shortness of breath, fever, cough, or wheezing. Your healthcare provider may do a chest x-ray if you have any of these symptoms. • Blood clots (Venous Thromboembolism, [VTE]). Some people may develop a blood clot in a deep vein, usually in the leg (venous thrombosis), or a clot in the lungs (pulmonary embolism, [PE]) which may be severe or lead to death. Tell your healthcare provider right away if you have any symptoms such as pain or swelling in an extremity, shortness of breath, chest pain, breathing that is more rapid than normal (tachypnea), or heart beats faster than normal (tachycardia). […]
From the patient leaflet: What should I avoid while taking Lynparza?Avoid grapefruit, grapefruit juice, Seville oranges and Seville orange juice during treatment with Lynparza since they may increase the level of Lynparza in your blood.
From the patient leaflet: How should I store Lynparza?Store Lynparza at room temperature, between 68°F to 77°F (20°C to 25°C). • Store Lynparza in the original bottle to protect it from moisture. Keep Lynparza and all medicines out of reach of children.
Source: FDA drug label (Lynparza), AstraZeneca Pharmaceuticals LP, effective July 10, 2025 (SPL set 741ff3e3-dc1a-45a6-84e5-2481b27131aa), via openFDA; the full label on DailyMed
Is there a generic for olaparib (Lynparza)?
No generic olaparib is approved (Drugs@FDA, October 8, 2026). Drugs@FDA also holds 4 tentative approvals: the FDA found the generic approvable, but patents or exclusivity keep it from final approval for now.
The Orange Book lists 11 patents for Lynparza tablets: the compound patent runs to September 8, 2027, and the last listed entry to October 25, 2041. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2014 earliest approval on file
- 2041 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the olaparib label say about other medicines?
The olaparib label names no other medicine on this site. The labels of 2 other medicines name olaparib. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
Other labels that name olaparib
Source: FDA drug label (Lynparza), AstraZeneca Pharmaceuticals LP, effective July 10, 2025 (SPL set 741ff3e3-dc1a-45a6-84e5-2481b27131aa), via openFDA; the full label on DailyMed
What do FAERS reports show for olaparib?
The FDA Adverse Event Reporting System holds 20,798 reports that list olaparib among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 5,936 are coded as a death and 3,825 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 olaparib?
19 other medicines are given the same way (oral) and in the same FDA class as olaparib 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 |
|---|---|---|---|---|
| Talazoparib | 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 |
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to olaparib
- 19 medicines for the same use
- Other poly(adp-ribose) polymerase inhibitors
- the pharmacologic class, with prices and generics
- Olaparib side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other