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Serving leading biopharmaceutical companies globally:

Argus Health
QuintilesIMS
Moodys
McKesson
UBS
Express Scripts
McKinsey
Dow
Cipla
Daiichi Sankyo

Generated: February 17, 2018

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-two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibrutinib has two hundred and ten patent family members in thirty-eight countries.

There are thirteen drug master file entries for ibrutinib. One supplier is listed for this compound.
Pharmacology for ibrutinib
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for ibrutinib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Non-Orange Book US Patents for 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
8,088,781 Inhibitors of brutons tyrosine kinase ➤ Sign Up
9,133,202 Inhibitors of Bruton's tyrosine kinase ➤ Sign Up
8,883,435 Inhibitors of Bruton's tyrosine kinase ➤ Sign Up
8,691,546 Inhibitors of Bruton's tyrosine kinase ➤ Sign Up
8,658,653 Inhibitors of Bruton's tyrosine kinase ➤ Sign Up
8,748,439 Inhibitors of Bruton's tyrosine kinase ➤ Sign Up
8,759,516 Inhibitors of Bruton's tyrosine kinase ➤ Sign Up
9,206,189 Inhibitors of bruton's tyrosine kinase ➤ Sign Up
8,552,010 Inhibitors of Bruton'S tyrosine kinase ➤ Sign Up
7,732,454 Inhibitors of Bruton's tyrosine kinase ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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International Patents for ibrutinib

Supplementary Protection Certificates for ibrutinib

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90021-0 Sweden ➤ Sign Up PRODUCT NAME: IBRUTINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/14/945 20141023
C0029 France ➤ Sign Up PRODUCT NAME: IBRUTINIB OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE: EU/1/14/945 20141023
0150014 00145 Estonia ➤ Sign Up PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
0844 Netherlands ➤ Sign Up PRODUCT NAME: IBRUTINIB, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 - C(2016)3293 20160530
2016034 Lithuania ➤ Sign Up PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
2017009 Lithuania ➤ Sign Up PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2017000015 Germany ➤ Sign Up PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945-C(2015)4704 20150703
15/020 Ireland ➤ Sign Up PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
3 5006-2015 Slovakia ➤ Sign Up PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
2015017 Lithuania ➤ Sign Up PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Colorcon
Harvard Business School
McKesson
US Department of Justice
Julphar
Healthtrust
Deloitte
McKinsey
Merck

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