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Last Updated: July 2, 2022

Olaparib - Generic Drug Details


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What are the generic drug sources for olaparib and what is the scope of patent protection?

Olaparib is the generic ingredient in one branded drug marketed by Astrazeneca and is included in two NDAs. There are eleven patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olaparib has two hundred and eighty-three patent family members in fifty countries.

There are three drug master file entries for olaparib. One supplier is listed for this compound.

Summary for olaparib
International Patents:283
US Patents:11
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 126
Clinical Trials: 339
Patent Applications: 1,614
What excipients (inactive ingredients) are in olaparib?olaparib excipients list
DailyMed Link:olaparib at DailyMed
Recent Clinical Trials for olaparib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
University of Colorado, DenverPhase 2
European Organisation for Research and Treatment of Cancer - EORTCPhase 2
University of UtahPhase 1/Phase 2

See all olaparib clinical trials

Pharmacology for olaparib

US Patents and Regulatory Information for olaparib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca LYNPARZA olaparib CAPSULE;ORAL 206162-001 Dec 19, 2014 DISCN Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for olaparib

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Astrazeneca LYNPARZA olaparib CAPSULE;ORAL 206162-001 Dec 19, 2014 See Plans and Pricing See Plans and Pricing
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 See Plans and Pricing See Plans and Pricing
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

EU/EMA Drug Approvals for olaparib

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
AstraZeneca AB Lynparza olaparib EMEA/H/C/003726
Ovarian cancerLynparza is indicated as monotherapy for the:maintenance treatment of adult patients with advanced (FIGO stages III and IV) BRCA1/2-mutated (germline and/or somatic) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy.maintenance treatment of adult patients with platinum sensitive relapsed high grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete or partial) to platinum based chemotherapy.Lynparza in combination with bevacizumab is indicated for the:maintenance treatment of adult patients with advanced (FIGO stages III and IV) high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are in response (complete or partial) following completion of first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD) positive status defined by either a BRCA1/2 mutation and/or genomic instability (see section 5.1).Breast cancerLynparza is indicated as monotherapy for the treatment of adult patients with germline BRCA1/2-mutations, who have HER2 negative locally advanced or metastatic breast cancer. Patients should have previously been treated with an anthracycline and a taxane in the (neo)adjuvant or metastatic setting unless patients were not suitable for these treatments (see section 5.1).Patients with hormone receptor (HR)-positive breast cancer should also have progressed on or after prior endocrine therapy, or be considered unsuitable for endocrine therapy.Adenocarcinoma of the pancreasLynparza is indicated as monotherapy for the maintenance treatment of adult patients with germline BRCA1/2-mutations who have metastatic adenocarcinoma of the pancreas and have not progressed after a minimum of 16 weeks of platinum treatment within a first-line chemotherapy regimen.Prostate cancerLynparza is indicated as monotherapy for the treatment of adult patients with metastatic castration-resistant prostate cancer and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.Lynparza is indicated as monotherapy for the maintenance treatment of adult patients with platinum sensitive relapsed BRCA mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response (complete response or partial response) to platinum based chemotherapy. 
Authorised no no no 2014-12-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for olaparib

Country Patent Number Title Estimated Expiration
Poland 1633724 See Plans and Pricing
Norway 2018038 See Plans and Pricing
Norway 335959 See Plans and Pricing
Dominican Republic P2011000094 FORMULACION FARMACEUTICA 514 See Plans and Pricing
Malaysia 162829 PHTHALAZINONE DERIVATIVE See Plans and Pricing
Cyprus 1112345 See Plans and Pricing
European Patent Office 1330442 DERIVES DE PHTALAZINONE (PHTHALAZINONE DERIVATIVES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for olaparib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2346495 300956 Netherlands See Plans and Pricing PRODUCT NAME: AMORF OLAPARIB OF EEN ZOUT OF SOLVAAT DAARVAN, IN EEN VASTE DISPERSIE; REGISTRATION NO/DATE: EU1/14/959 20180515
1633724 122015000025 Germany See Plans and Pricing PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
2346495 2018C/042 Belgium See Plans and Pricing PRODUCT NAME: L'OLAPARIB AMORPHE OU SEL OU SOLVATES, EN DISPERSION SOLIDE; AUTHORISATION NUMBER AND DATE:
1633724 C20150012 00136 Estonia See Plans and Pricing PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
2346495 LUC00091 Luxembourg See Plans and Pricing PRODUCT NAME: OLAPARIB AMORPHE OU UN DE SES SELS OU UN DES SES SOLVATES DANS UNE DISPERSION SOLIDE; AUTHORISATION NUMBER AND DATE: EU/1/14/959 20180515
1633724 CR 2015 00012 Denmark See Plans and Pricing PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
1633724 92680 Luxembourg See Plans and Pricing PRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.