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Olaparib - Generic Drug Details

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

This ingredient has one hundred and ninety-nine patent family members in forty-two countries.

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

Summary for Generic Name: olaparib

Tradenames:1
Patents:7
Applicants:1
NDAs:1
Drug Master File Entries: see list1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list89
Clinical Trials: see list69
Patent Applications: see list72
Drug Prices:see low prices
DailyMed Link:olaparib at DailyMed

Pharmacology for Ingredient: olaparib

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Astrazeneca Pharms
LYNPARZA
olaparib
CAPSULE;ORAL206162-001Dec 19, 2014RXNoNo7,449,464► subscribeYY ► subscribe
Astrazeneca Pharms
LYNPARZA
olaparib
CAPSULE;ORAL206162-001Dec 19, 2014RXNoNo8,143,241► subscribe ► subscribe
Astrazeneca Pharms
LYNPARZA
olaparib
CAPSULE;ORAL206162-001Dec 19, 2014RXNoNo7,151,102► subscribeYY ► 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
8,071,579DNA damage repair inhibitors for the treatment of cancer► subscribe
7,662,818Phthalazinone derivatives► subscribe
7,531,530Therapeutic compounds► 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
World Intellectual Property Organization (WIPO)2005053662► subscribe
Japan5719471► subscribe
Japan4027406► 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
680Luxembourg► subscribePRODUCT NAME: OLAPARIB AINSI QUE DES SELS ET DES SOLVATES DE CELUI-CI. FIRST REGISTRATION: 20141218
0150012 00136Estonia► subscribePRODUCT NAME: OLAPARIIB;REG NO/DATE: EU/1/14/959 18.12.2014
C0022France► subscribePRODUCT NAME: OLAPARIB,SELS ET SOLVATES DE CELUI-CI; REGISTRATION NO/DATE: EU 1/14/959 20141218
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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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