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Last Updated: August 7, 2020

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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 Pharms and is included in two NDAs. There are nine patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olaparib has two hundred and seventy-nine 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:279
US Patents:9
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 3
Suppliers / Packagers: 1
Bulk Api Vendors: 118
Clinical Trials: 254
Patent Applications: 393
DailyMed Link:olaparib at DailyMed
Recent Clinical Trials for olaparib

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

SponsorPhase
Ruijin HospitalPhase 1/Phase 2
Florida Department of HealthPhase 2
Baptist Health South FloridaPhase 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 208558-001 Aug 17, 2017 RX Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms LYNPARZA olaparib CAPSULE;ORAL 206162-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
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 CAPSULE;ORAL 206162-001 Dec 19, 2014 RX Yes Yes   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms LYNPARZA olaparib CAPSULE;ORAL 206162-001 Dec 19, 2014 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   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
2346495 122018000124 Germany   Start Trial PRODUCT NAME: AMORPHES OLAPARIB, ODER EIN SALZ ODER SOLVAT DAVON, IN EINER FESTEN DISPERSION; REGISTRATION NO/DATE: EU/1/14/959/002-005 20180508
2346495 2018C/042 Belgium   Start Trial PRODUCT NAME: L'OLAPARIB AMORPHE OU SEL OU SOLVATES, EN DISPERSION SOLIDE; AUTHORISATION NUMBER AND DATE:
1633724 PA2015016 Lithuania   Start Trial PRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724 1590019-4 Sweden   Start Trial PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
1633724 13/2015 Austria   Start Trial PRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724 PA2015016,C1633724 Lithuania   Start Trial PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
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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