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Last Updated: July 24, 2024

OLAPARIB - Generic Drug Details


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What are the generic drug 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 fifty-four patent family members in fifty-two countries.

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

Summary for OLAPARIB
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for OLAPARIB
Generic Entry Dates for OLAPARIB*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for OLAPARIB*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for OLAPARIB

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

SponsorPhase
Lee Ocuin, MDPhase 2
University of Alabama at BirminghamPhase 2
University Medical Center GroningenPhase 4

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 ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca LYNPARZA olaparib CAPSULE;ORAL 206162-001 Dec 19, 2014 DISCN Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No ⤷  Sign Up ⤷  Sign Up Y ⤷  Sign Up
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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 TABLET;ORAL 208558-002 Aug 17, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca LYNPARZA olaparib CAPSULE;ORAL 206162-001 Dec 19, 2014 ⤷  Sign Up ⤷  Sign Up
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 ⤷  Sign Up ⤷  Sign Up
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 ⤷  Sign Up ⤷  Sign Up
>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 or in combination with endocrine therapy for the adjuvant treatment of adult patients with germline BRCA1/2-mutations who have HER2-negative, high risk early breast cancer previously treated with neoadjuvant or adjuvant chemotherapy (see sections 4.2 and 5.1).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 (mCRPC) and BRCA1/2-mutations (germline and/or somatic) who have progressed following prior therapy that included a new hormonal agent.in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with mCRPC in whom chemotherapy is not clinically indicated (see section 5.1).
Authorised no no no 2014-12-16
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for OLAPARIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2346495 PA2018014 Lithuania ⤷  Sign Up PRODUCT NAME: AMORFINIS OLAPARIBAS ARBA JO DRUSKA ARBA SOLVATAS KIETOJE DISPERSIJOJE; REGISTRATION NO/DATE: EU/1/14/959 20180508
1633724 CR 2015 00012 Denmark ⤷  Sign Up PRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
2346495 300956 Netherlands ⤷  Sign Up PRODUCT NAME: AMORF OLAPARIB OF EEN ZOUT OF SOLVAAT DAARVAN, IN EEN VASTE DISPERSIE; REGISTRATION NO/DATE: EU1/14/959 20180515
1633724 2015C/024 Belgium ⤷  Sign Up PRODUCT NAME: OLAPARIB ET LES SELS ET SOLVATES DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/959 20141218
1633724 213 50005-2015 Slovakia ⤷  Sign Up PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
2346495 2018C/042 Belgium ⤷  Sign Up PRODUCT NAME: L'OLAPARIB AMORPHE OU SEL OU SOLVATES, EN DISPERSION SOLIDE; AUTHORISATION NUMBER AND DATE:
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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