Logos are each company's own site icon, matched by name through Wikidata.Company names and logos identify the companies in public FDA and registry records and do not imply endorsement.
Treats deleterious or suspected deleterious germline or … primary peritoneal cancer. Sold as Lynparza. Every FDA application for this active ingredient: 2 branded and 4 generic.
As of Nov 14, 2026, FDA lists 6 applications for Olaparib (sold as Lynparza), first approved Dec 19, 2014, with 15 new uses approved and 0 published complete response letters.
First approved: Dec 19, 2014
Applications: 6
New uses approved: 15
Complete response letters: 0
Medicare spending, 2025: $820M
Orphan exclusivity until: May 8, 2027
First approved in the EU: Dec 16, 2014
First approved in Japan: Jan 19, 2018
Medicare Spending
CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name
First approved in Japan 37 months after the US. PMDA's English list since 2008, matched by ingredient; see all Japanese approvals
LynparzaDrugs with a new indication and a new dosage for the maintenance therapy of advanced or recurrent endometrial cancer with proficient mismatch repair (pMMR)… · AstraZeneca K.K. · Nov 22, 2024
LynparzaDrugs with a new dosage indicated for the treatment of BRCA mutation-positive, metastatic castration-resistant prostate cancer. · AstraZeneca K.K. · Aug 23, 2023 · Review report
LynparzaDrugs with a new indication and a new dosage for the postoperative adjuvant treatment of BRCA mutation- positive and HER2-negative breast cancer with a high… · AstraZeneca K.K. · Aug 24, 2022
LynparzaDrugs with new indications and new dosage for the maintenance treatment of homologous recombination deficiency (HRD)-positive ovarian cancer in patients who… · AstraZeneca K.K. · Dec 25, 2020
LynparzaDrugs with a new indication and a new dosage for maintenance therapy of unresectable BRCA mutation- positive pancreatic cancer after chemotherapy including… · AstraZeneca K.K. · Dec 25, 2020
LynparzaDrugs with a new indication for maintenance treatment of BRCA mutation-positive ovarian cancer in patients who have received first chemotherapy. · AstraZeneca K.K. · Jun 18, 2019
LynparzaDrugs with a new additional indication for the treatment of unresectable or recurrent BRCA mutation-positive and HER2-negative breast cancer in patients who… · AstraZeneca K.K. · Jul 2, 2018
Lynparza, new ingredientDrugs with a new active ingredient indicated for the maintenance treament of recurrent ovarian cancer in patients who are in a complete or partial response… · AstraZeneca K.K. · Jan 19, 2018
Clinical Trials
227 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient.Drugs@FDA
Astrazeneca
Zydus Pharms USA Inc