Lynparza
A targeted oral therapy for BRCA-mutated ovarian, breast and prostate cancers.
Where Olaparib is approved
All regulators →Of the three regulators tracked here, the first to approve Olaparib was the EU, on 16 Dec 2014. It is approved in 3 of the 3 regulators tracked here.
- 1 EU orphan designation, most recently for treatment of ovarian cancer (6 Dec 2007, withdrawn)
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
Olaparib patents and exclusivity
Expiry tracker →Protections still running for marketed products containing Olaparib, as listed by the regulators. Expired patents and exclusivities, and discontinued products, are not shown.
- 11 listed patents; the last listed expires 25 Oct 2041 (US 11970530).
- Latest patent on the drug substance itself: 8 Sep 2027 (US 7449464).
- Exclusivity ODE-306: Orphan drug exclusivity: w/ bevacizumab for maint tx of adults w/ adv epithelial ovarian, fallopian tube, or primary peritoneal ca in compl…, until 8 May 2027.
- Exclusivity ODE-283: Orphan drug exclusivity: maintenance tx of adults w/ deleterious or suspected deleterious gbrcam metastatic pancreatic adenocarcinoma whose…, until 27 Dec 2026.
Reproduced from the FDA Orange Book and Purple Book (checked 5 Oct 2026) and the European Commission's Union Register of medicinal products (CC BY 4.0; the EU expiry date is calculated exactly as the Commission's register displays it). Listed patents and dates are as submitted to or published by the regulator and may not reflect litigation, invalidation, settlements, lapsed fees or later extensions. This is not legal advice or a freedom-to-operate opinion, and it does not say when a generic or biosimilar will launch.
What health systems spend on Olaparib
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Olaparib works
All drug targets →- PARP 1, 2 and 3 inhibitor InhibitorTarget: PARP 1, 2 and 3✓ In ChEMBL and the Guide to Pharmacology
- Breast cancerPhase 3
- CancerPhase 3
- Colorectal cancerPhase 3
- Endometrial cancerPhase 3
- Fallopian tube carcinomaPhase 3
- Gastric cancerPhase 3
- Malignant epithelial tumor of ovaryPhase 3
- Malignant pancreatic neoplasmPhase 3
- MelanomaPhase 3
- Non-small cell lung carcinomaPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL521686, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3), ligand 7519, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Olaparib
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 14 technology appraisals of Olaparib. 9 are current, and 8 of these recommend it for at least some patients. 5 older appraisals were replaced or withdrawn.
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Olaparib
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 2 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: LynparzaEMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Olaparib
- ATC code
- L01XX46
- ChEMBL
- CHEMBL521686
- DrugBank
- DB09074
- PubChem CID
- 23725625
- CAS number
- 763113-22-0
- FDA UNII
- WOH1JD9AR8
- Wikidata
- Q7083106
- Wikipedia
- Olaparib
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
What Lynparza is used for
Lynparza 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. ( 1.1 , 2.1 ) • in combination with bevacizumab for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in 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: • a deleterious or suspected deleterious BRCA mutation, and/or • genomic i…
How it works
12.1 Mechanism of Action Olaparib is an inhibitor of poly (ADP-ribose) polymerase (PARP) enzymes, including PARP1, PARP2, and PARP3. PARP enzymes are involved in normal cellular functions, such as DNA transcription and DNA repair. Olaparib has been shown to inhibit growth of select tumor cell lines in vitro and decrease tumor growth in mouse xenograft models of human cancer, both as monotherapy or following platinum-based chemotherapy. Increased cytotoxicity and anti-tumor activity following treatment with olaparib were noted in cell lines and mouse tumor models with deficiencies in BRCA1/2 , ATM , or other genes involved in the homologous recombination repair (HRR) of DNA damage and correl…
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How this page is built
The facts on this page are pulled directly from official U.S. FDA datasets — they are not written from memory. Each field below names the dataset it came from, so you can check it yourself.
- FDA Drug Label (openFDA) ↗ Indications, mechanism of action and pharmacologic class
- Drugs@FDA ↗ First FDA approval date and the company holding the application
- FDA Drug Shortage Database ↗ Current US supply / shortage status
Plain-English summaries and drug-class explainers are written and reviewed by Sreepriya Prasannan (MSc Digital Transformation of Life Sciences (Innopharma Education / Griffith College); MSc & BSc Botany). Data is retrieved automatically from the sources above and cross-checked with AI-assisted verification (Anthropic's Claude) — brand and generic names are matched against the exact FDA product record so that a combination product or a different formulation cannot be mistaken for the drug on this page. An editor reviews the result before publication. We describe this in full in our editorial standards and corrections policy. The FDA data on this page was last retrieved on 9 Oct 2026. How every register is built: methodology · fixes we have made: corrections log.