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Last Updated: October 20, 2019

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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 two NDAs. There are thirty-two patents protecting this drug and four Paragraph IV challenges.

This drug has two hundred and seventy-four patent family members in thirty-nine countries.

The generic ingredient in IMBRUVICA is ibrutinib. There are sixteen drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the ibrutinib profile page.

Drug patent expirations by year for IMBRUVICA
Drug Prices for IMBRUVICA

See drug prices for IMBRUVICA

Generic Entry Opportunity Date for IMBRUVICA
Generic Entry Dates for IMBRUVICA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for IMBRUVICA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for IMBRUVICA

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Eli Lilly and CompanyPhase 1
TG Therapeutics, Inc.Phase 2
Kerry RogersPhase 2

See all IMBRUVICA clinical trials

Recent Litigation for IMBRUVICA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pharmacyclics LLC v. Alvogen Pine Brook LLC2019-03-01
Pharmacyclics LLC v. Zydus Worldwide DMCC2019-01-28
Pharmacyclics LLC v. Hetero USA Inc.2019-01-04

See all IMBRUVICA litigation

PTAB Litigation
PetitionerDate
Sandoz Inc.2019-03-21
Coalition for Affordable Drugs IV LLC2015-04-20

See all IMBRUVICA litigation

Pharmacology for IMBRUVICA
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for IMBRUVICA
(R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one
(R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-ylprop-2-en-1-one
1-((R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one
1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one
1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-2-propen-1-one1-[(3R)-3-[4-AMino-3-(4-phenoxyphenyl)pyrazolo[3, 4-d]pyriMidin-1-yl]
1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]-2-propen-1-one
1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one
1-[(3R)-3-[4-Amino-3-(4-phenoxyphenyl)pyrazolo[3, 4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one
1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidyl]prop-2-en-1-one
1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl]prop-2-en-1-one
1-{(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]piperidin-1-yl}prop-2-en-1-one
1X70OSD4VX
2-Propen-1-one, 1-((3R)-3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo(3,4-d)pyrimidin-1-yl)-1-piperidinyl)-
2-Propen-1-one, 1-[(3R)-3-[4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl]-1-piperidinyl]-
936563-96-1
A1-01649
AB0008168
ABP000965
AC-26942
ACN-030256
AJ-91306
AKOS022185476
AMX10219
AN-1333
AOB87789
AX8254580
BDBM50357312
CHEBI:76612
CHEMBL1873475
CRA 032765
CRA-032765
D10223
DB09053
EBD2165770
EX-5960
EX-A066
FT-0696693
GTPL6912
HSDB 8260
HY-10997
Ibrutinib
Ibrutinib (JAN/USAN)
Ibrutinib (PCI-32765)
Ibrutinib (PCI32765)
Ibrutinib [USAN:INN]
Ibrutinib(PCI-32765)
Ibrutinib/PCI-32765
IbrutinibCI-32765mbruvica(R)-1-(3-(4-amino-3-(4-phenoxyphenyl)-1H-pyrazolo[3,4-d]pyrimidin-1-yl)piperidin-1-yl)prop-2-en-1-one
ibrutinibum
Imbruvica (TN)
J-523872
JNJ 02
KB-79777
KIN0000174
KS-000002KE
MLS006010041
MolPort-027-806-955
NCGC00187912-01
NCGC00187912-02
NCGC00187912-03
NCGC00187912-12
Pc-32765
PCI 32765
PCI-32765
PCI-32765 (Ibrutinib)
PCI-32765-00
PCI-32765(Ibrutinib)
PCI32765
piperidin-1-yl]prop-2-en-1-one1-{3-[4-AMino-3-(4-phenoxy-phenyl)-pyrazolo[3,4-d]pyriMidin-1-yl]-piperidin-1-yl}-propenone
QC-4573
S-7810
SB14736
SC-96633
SCHEMBL201859
SMR004701213
SW218096-2
UNII-1X70OSD4VX
X7513
XYFPWWZEPKGCCK-GOSISDBHSA-N
ZINC35328014

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   Start Trial   Start Trial   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-004 Feb 16, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-002 Dec 20, 2017 RX Yes No   Start Trial   Start Trial Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration
Paragraph IV (Patent) Challenges for IMBRUVICA
Drugname Dosage Strength RLD Date
➤ Subscribe Tablets 140 mg and 560 mg ➤ Subscribe   Start Trial
➤ Subscribe Tablets 280 mg and 420 mg ➤ Subscribe   Start Trial
➤ Subscribe Capsules 70 mg ➤ Subscribe   Start Trial
➤ Subscribe Capsules 140 mg ➤ Subscribe   Start Trial

Supplementary Protection Certificates for IMBRUVICA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2526934 CA 2016 00056 Denmark   Start Trial PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
2201840 PA2015017,C2201840 Lithuania   Start Trial PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 1590021-0 Sweden   Start Trial PRODUCT NAME: IBRUTINIB ELLER ETT FARMACEUTISKT GODTAGBART SALT DAERAV; REG. NO/DATE: EU/1/14/945 20141023
2201840 2015/020 Ireland   Start Trial PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 C300728 Netherlands   Start Trial PRODUCT NAME: IBRUTINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840 C20150014 00145 Estonia   Start Trial PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Medtronic
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Merck
McKinsey
Colorcon
Boehringer Ingelheim

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