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Last Updated: October 24, 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 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-one 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:281
US Patents:11
Tradenames:1
Applicants:1
NDAs:2
Drug Master File Entries: 3
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 122
Clinical Trials: 294
Patent Applications: 1,440
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
Institut fuer FrauengesundheitPhase 2
Repare TherapeuticsPhase 1/Phase 2
AGO Research GmbHPhase 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 ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca LYNPARZA olaparib CAPSULE;ORAL 206162-001 Dec 19, 2014 DISCN Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-001 Aug 17, 2017 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Astrazeneca LYNPARZA olaparib TABLET;ORAL 208558-002 Aug 17, 2017 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial Y Y ⤷  Free Forever 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 1590019-4 Sweden ⤷  Free Forever Trial PRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REG. NO/DATE: EU/1/14/959 20141218
2346495 LUC00091 Luxembourg ⤷  Free Forever Trial 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 213 50005-2015 Slovakia ⤷  Free Forever Trial PRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
2346495 PA2018014 Lithuania ⤷  Free Forever Trial PRODUCT NAME: AMORFINIS OLAPARIBAS ARBA JO DRUSKA ARBA SOLVATAS KIETOJE DISPERSIJOJE; REGISTRATION NO/DATE: EU/1/14/959 20180508
1633724 C300726 Netherlands ⤷  Free Forever Trial PRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
1633724 PA2015016,C1633724 Lithuania ⤷  Free Forever Trial PRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
1633724 92680 Luxembourg ⤷  Free Forever Trial 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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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Boehringer Ingelheim
Dow
AstraZeneca
Harvard Business School
Moodys

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