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Last Updated: January 20, 2021

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OLAPARIB - Generic Drug Details

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

Olaparib is the generic ingredient in one branded drug marketed by Astrazeneca Pharms 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 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:280
US Patents:11
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 3
Suppliers / Packagers: 1
Bulk Api Vendors: 120
Clinical Trials: 272
Patent Applications: 778
DailyMed Link:OLAPARIB at DailyMed
Recent Clinical Trials for OLAPARIB

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

SponsorPhase
AGO Research GmbHPhase 2
Washington University School of MedicinePhase 2
Joseph Sanchez FoundationPhase 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 Pharms LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for OLAPARIB

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1633724 S1500012 Hungary   Start Trial PRODUCT NAME: OLAPARIB
1633724 C 2015 011 Romania   Start Trial PRODUCT NAME: OLAPARIB; NATIONAL AUTHORISATION NUMBER: EU/1/14/959/001; DATE OF NATIONAL AUTHORISATION: 20141216; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/14/959/001; DATE OF FIRST AUTHORISATION IN EEA: 20141216
1633724 1590019-4 Sweden   Start Trial PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
1633724 C20150012 00136 Estonia   Start Trial PRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
1633724 2015/016 Ireland   Start Trial PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Colorcon
McKinsey
AstraZeneca
Merck
Mallinckrodt

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