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Serving leading biopharmaceutical companies globally:

Queensland Health
Federal Trade Commission
Dow
Argus Health
Covington
Mallinckrodt
Express Scripts
Moodys
Johnson and Johnson
Daiichi Sankyo

Generated: January 20, 2018

DrugPatentWatch Database Preview

IMBRUVICA Drug Profile

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When do Imbruvica patents expire, and when can generic versions of Imbruvica launch?

Imbruvica is a drug marketed by Pharmacyclics Inc and is included in one NDA. There are twenty-one patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in IMBRUVICA is ibrutinib. There are thirteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.
Summary for IMBRUVICA
Drug patent expirations by year for IMBRUVICA
Pharmacology for IMBRUVICA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors

US Patents and Regulatory Information for IMBRUVICA

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 ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe Y Y ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes ➤ Subscribe ➤ Subscribe ➤ Subscribe
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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Paragraph IV (Patent) Challenges for IMBRUVICA
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Capsules 140 mg ➤ Subscribe 11/13/2017

Non-Orange Book US Patents for IMBRUVICA

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
9,556,182 Inhibitors of Bruton's tyrosine kinase ➤ Subscribe
8,158,786 Inhibitors of Bruton's tyrosine kinase ➤ Subscribe
8,563,563 Inhibitors of bruton's tyrosine kinase ➤ Subscribe
8,809,273 Inhibitors of Bruton's tyrosine kinase ➤ Subscribe
7,732,454 Inhibitors of Bruton's tyrosine kinase ➤ Subscribe
8,975,266 Inhibitors of Bruton's tyrosine kinase ➤ Subscribe
8,883,435 Inhibitors of Bruton's tyrosine kinase ➤ Subscribe
8,399,470 Inhibitors of bruton's tyrosine kinase ➤ Subscribe
8,741,908 Inhibitors of bruton's tyrosine kinase ➤ Subscribe
8,735,404 Inhibitors of Bruton's tyrosine kinase ➤ Subscribe
Patent No. Title Estimated Patent Expiration

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International Patents for IMBRUVICA

Supplementary Protection Certificates for IMBRUVICA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
15/020 Ireland ➤ Subscribe PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
2017000015 Germany ➤ Subscribe PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945-C(2015)4704 20150703
2015 00021 Denmark ➤ Subscribe PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141023
2015017 Lithuania ➤ Subscribe PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
2015017,C2201840 Lithuania ➤ Subscribe PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021
2016034 Lithuania ➤ Subscribe PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
90021-0 Sweden ➤ Subscribe PRODUCT NAME: IBRUTINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/14/945 20141023
2016 00056 Denmark ➤ Subscribe PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
/2015 Austria ➤ Subscribe PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021
2015 00021 Denmark ➤ Subscribe PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving leading biopharmaceutical companies globally:

Fuji
Queensland Health
McKinsey
Boehringer Ingelheim
Johnson and Johnson
US Army
Federal Trade Commission
Moodys
McKesson

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