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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
US Department of Justice
Medtronic
Argus Health
Cerilliant
Merck
Julphar
QuintilesIMS
McKinsey
Baxter

Generated: December 17, 2017

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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 olaparib freedom to operate?

Olaparib
is the generic ingredient in one branded drug marketed by Astrazeneca Pharms and is included in two NDAs. There are eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Olaparib has two hundred and sixty-four patent family members in forty-eight countries and twelve supplementary protection certificates in eleven countries.

There is one drug master file entry for olaparib. One supplier is listed for this compound.

Pharmacology 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 PharmsLYNPARZAolaparibTABLET;ORAL208558-002Aug 17, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsLYNPARZAolaparibTABLET;ORAL208558-001Aug 17, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsLYNPARZAolaparibTABLET;ORAL208558-002Aug 17, 2017RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsLYNPARZAolaparibTABLET;ORAL208558-002Aug 17, 2017RXYesYes► Subscribe► SubscribeY► Subscribe
Astrazeneca PharmsLYNPARZAolaparibTABLET;ORAL208558-001Aug 17, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsLYNPARZAolaparibTABLET;ORAL208558-001Aug 17, 2017RXYesNo► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsLYNPARZAolaparibTABLET;ORAL208558-002Aug 17, 2017RXYesYes► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsLYNPARZAolaparibCAPSULE;ORAL206162-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
Astrazeneca PharmsLYNPARZAolaparibTABLET;ORAL208558-001Aug 17, 2017RXYesNo► Subscribe► SubscribeYY► Subscribe
Astrazeneca PharmsLYNPARZAolaparibCAPSULE;ORAL206162-001Dec 19, 2014RXYesYes► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: olaparib

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
7,351,701Therapeutic compounds► Subscribe
7,662,818Phthalazinone derivatives► Subscribe
7,692,006Phthalazinone derivatives► Subscribe
9,566,276Phthalazinone derivatives► Subscribe
7,750,006Phthalazinone derivatives► Subscribe
7,531,530Therapeutic compounds► Subscribe
9,169,235Phthalazinone derivatives► Subscribe
8,071,579DNA damage repair inhibitors for the treatment of cancer► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: olaparib

Country Document Number Estimated Expiration
EcuadorSP056094► Subscribe
Russian Federation2010149166► Subscribe
Portugal1684736► Subscribe
HungaryE025996► Subscribe
Serbia55157► Subscribe
Spain2371469► Subscribe
TunisiaSN05212► Subscribe
Spain2587129► Subscribe
Japan2006519827► Subscribe
Israel176013► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: OLAPARIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
3 50005-2015Slovakia► SubscribePRODUCT NAME: OLAPARIB; REGISTRATION NO/DATE: EU/1/14/959 20141218
2015016,C1633724Lithuania► SubscribePRODUCT NAME: OLAPARIBAS IR JO DRUSKOS IR SOLVATAI; REGISTRATION NO/DATE: EU/1/14/959 20141216
C0022France► SubscribePRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
/2015Austria► SubscribePRODUCT NAME: OLAPARIB UND SALZE UND SOLVATE DAVON; REGISTRATION NO/DATE: EU/1/14/959 20141216
2015016Lithuania► SubscribePRODUCT NAME: OLAPARIBUM; REGISTRATION NO/DATE: EU/1/14/959 20141216
2015 00012Denmark► SubscribePRODUCT NAME: OLAPARIB, OG SALTE OG SOLVATER DERAF; REG. NO/DATE: EU/1/14/959/001 20141216
680Luxembourg► SubscribePRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
15/016Ireland► SubscribePRODUCT NAME: OLAPARIB, AND SALTS AND SOLVATES THEREOF; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
500012Hungary► SubscribePRODUCT NAME: OLAPARIB
00726Netherlands► SubscribePRODUCT NAME: OLAPARIB, EN ZOUTEN EN; REGISTRATION NO/DATE: EU/1/14/959/001 20141216
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Serving leading biopharmaceutical companies globally:

Deloitte
Boehringer Ingelheim
QuintilesIMS
McKinsey
Argus Health
Chubb
Moodys
Medtronic
Federal Trade Commission
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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