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Last Updated: January 30, 2023

Olaparib - Generic Drug Details


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What are the generic sources for olaparib and what is the scope of freedom to operate?

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: 130
Clinical Trials: 358
Patent Applications: 1,683
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
Zin W MyintPhase 2
National Taiwan University HospitalPhase 2
Alliance for Clinical Trials in OncologyPhase 2/Phase 3

See all olaparib clinical trials

Pharmacology for olaparib
Paragraph IV (Patent) Challenges for OLAPARIB
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
LYNPARZA Tablets olaparib 100 mg and 150 mg 208558 1 2022-11-01

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 208558-001 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 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 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 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 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 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
South Africa 200600679 THERAPEUTIC COMPOUNDS See Plans and Pricing
South Korea 101136702 See Plans and Pricing
European Patent Office 2064189 FORME POLYMORPHIQUE DE LA 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE (POLYMORPHIC FORM OF 4-[3-(4-CYCLOPROPANECARBONYL-PIPERAZINE-1-CARBONYL)-4-FLUORO-BENZYL]-2H-PHTHALAZIN-1-ONE) See Plans and Pricing
Mexico PA06006120 INHIBIDORES DE REPARACION DE DANO DE ACIDO DESOXIRRIBONUCLEICO PARA TRATAMIENTO DE CANCER. (DNA DAMAGE REPAIR INHIBITORS FOR TREATMENT OF CANCER.) See Plans and Pricing
United Kingdom 0026505 See Plans and Pricing
European Patent Office 2305221 Inhibiteurs de réparation d'ADN endommagé pour le traitement du cancer (DNA damage repair inhibitors for treatment of cancer) See Plans and Pricing
Russian Federation 2006105652 ТРИЦИКЛИЧЕСКИЕ ИНГИБИТОРЫ ПАРП 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 PA2018014 Lithuania See Plans and Pricing PRODUCT NAME: AMORFINIS OLAPARIBAS ARBA JO DRUSKA ARBA SOLVATAS KIETOJE DISPERSIJOJE; REGISTRATION NO/DATE: EU/1/14/959 20180508
1633724 122015000025 Germany See Plans and Pricing PRODUCT NAME: OLAPARIB, SOWIE SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724 C20150012 00136 Estonia See Plans and Pricing PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
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
2346495 122018000124 Germany See Plans and Pricing PRODUCT NAME: AMORPHES OLAPARIB, ODER EIN SALZ ODER SOLVAT DAVON, IN EINER FESTEN DISPERSION; REGISTRATION NO/DATE: EU/1/14/959/002-005 20180508
1633724 C300726 Netherlands See Plans and Pricing PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724 13/2015 Austria See Plans and Pricing PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Boehringer Ingelheim
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Harvard Business School
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