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Serving leading biopharmaceutical companies globally:

AstraZeneca
Cipla
Boehringer Ingelheim
Covington
Teva
Johnson and Johnson
US Army
UBS
Baxter
Farmers Insurance

Generated: December 11, 2017

DrugPatentWatch Database Preview

Ibrutinib - Generic Drug Details

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What are the generic drug sources for ibrutinib and what is the scope of ibrutinib freedom to operate?

Ibrutinib
is the generic ingredient in one branded drug marketed by Pharmacyclics Inc and is included in one NDA. There are twenty-one patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibrutinib has two hundred and thirteen patent family members in thirty-eight countries and twenty-two supplementary protection certificates in ten countries.

There are twelve drug master file entries for ibrutinib. One supplier is listed for this compound.

Pharmacology for ibrutinib

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
Pharmacyclics IncIMBRUVICAibrutinibCAPSULE;ORAL205552-001Nov 13, 2013RXYesYes► Subscribe► Subscribe► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: ibrutinib

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
8,809,273Inhibitors of Bruton's tyrosine kinase► Subscribe
8,748,439Inhibitors of Bruton's tyrosine kinase► Subscribe
8,236,812Inhibitors of bruton's tyrosine kinase► Subscribe
8,940,750Inhibitors of bruton's tyrosine kinase► Subscribe
9,556,182Inhibitors of Bruton's tyrosine kinase► Subscribe
8,741,908Inhibitors of bruton's tyrosine kinase► Subscribe
9,409,911Inhibitors of bruton's tyrosine kinase► Subscribe
9,266,893Inhibitors of Bruton's tyrosine kinase► Subscribe
8,658,653Inhibitors of Bruton's tyrosine kinase► Subscribe
7,732,454Inhibitors of Bruton's tyrosine kinase► 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: ibrutinib

Country Document Number Estimated Expiration
Chile2014003306► Subscribe
China106102745► Subscribe
Canada2847852► Subscribe
Japan2010504324► Subscribe
Slovenia2529621► Subscribe
Mexico347525► Subscribe
Slovenia2526771► Subscribe
SloveniaEP2201840► Subscribe
South Korea101425248► Subscribe
New Zealand575650► 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: IBRUTINIB

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2016000093Germany► SubscribePRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20160526
0868Netherlands► SubscribePRODUCT NAME: IBRUTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/945 - C(2015)4704 20150707
00728Netherlands► SubscribePRODUCT NAME: IBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 20141021
15/020Ireland► SubscribePRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
2017009Lithuania► SubscribePRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
0844Netherlands► SubscribePRODUCT NAME: IBRUTINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 - C(2016)3293 20160530
2016 00056Denmark► SubscribePRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
2015000027Germany► SubscribePRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20141021
90021-0Sweden► SubscribePRODUCT NAME: IBRUTINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/14/945 20141023
321Luxembourg► SubscribePRODUCT NAME: INHIBITEURS DE LA TYROSINE KINASE DE BRUTON
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

US Army
AstraZeneca
Harvard Business School
Farmers Insurance
McKinsey
Express Scripts
US Department of Justice
Julphar
Covington
Deloitte

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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