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Last Updated: October 15, 2019

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Ibrutinib - Generic Drug Details

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

Ibrutinib is the generic ingredient in one branded drug marketed by Pharmacyclics Inc and is included in two NDAs. There are thirty-two patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Ibrutinib has two hundred and seventy-two patent family members in thirty-nine countries.

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

Recent Clinical Trials for ibrutinib

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

SponsorPhase
Janssen Research & Development, LLCPhase 4
University College, LondonPhase 2/Phase 3
Eli Lilly and CompanyPhase 1

See all ibrutinib clinical trials

Recent Litigation for ibrutinib

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 ibrutinib litigation

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

See all ibrutinib litigation

Pharmacology for ibrutinib
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Synonyms for ibrutinib
(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 (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
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 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 TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No   See Pricing   See Pricing   See Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib CAPSULE;ORAL 205552-001 Nov 13, 2013 RX Yes Yes   See Pricing   See Pricing Y   See Pricing
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No   See Pricing   See Pricing Y   See Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for ibrutinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2201840 PA2015017 Lithuania   See Pricing PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
2526934 PA2016034 Lithuania   See Pricing PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
2526934 93321 Luxembourg   See Pricing PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 - IMBRUVICA - IBRUTINIB
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.