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Last Updated: April 1, 2020

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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-four 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 eighty-four patent family members in forty-one 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
ZKS Ulm (Zentrum für Klinische Studien Ulm)Phase 3
AmgenPhase 3
Christian BuskePhase 3

See all ibrutinib clinical trials

Recent Litigation for ibrutinib

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pharmacyclics LLC v. Sun Pharma Global FZE2020-03-20
Pharmacyclics LLC v. Alvogen Pine Brook LLC2019-03-01
Pharmacyclics LLC v. Zydus Worldwide DMCC2019-01-28

See all ibrutinib litigation

PTAB Litigation
PetitionerDate
2019-03-21
2015-04-20

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]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
AKOS022185476
AMX10219
AOB87789
AX8254580
BDBM50357312
CHEBI:76612
CHEMBL1873475
CRA 032765
CRA-032765
D10223
DB09053
DTXSID60893450
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
KIN0000174
KS-000002KE
MLS006010041
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
Q5984881
QC-4573
S-7810
SB14736
SC-96633
SCHEMBL201859
SMR004701213
SW218096-2
UNII-1X70OSD4VX
X7513
XYFPWWZEPKGCCK-GOSISDBHSA-N
ZINC35328014
Paragraph IV (Patent) Challenges for IBRUTINIB
Tradename Dosage Ingredient NDA Submissiondate
IMBRUVICA CAPSULE;ORAL ibrutinib 205552 2018-12-14
IMBRUVICA TABLET;ORAL ibrutinib 210563 2018-12-14
IMBRUVICA TABLET;ORAL ibrutinib 210563 2018-11-05
IMBRUVICA CAPSULE;ORAL ibrutinib 205552 2017-11-13

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   Start Trial   Start Trial   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No   Start Trial   Start Trial 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 TABLET;ORAL 210563-001 Feb 16, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
>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
2529621 CA 2017 00012 Denmark   Start Trial PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2015)4704 20150707
2526934 PA2016034 Lithuania   Start Trial PRODUCT NAME: IBRUTINIBAS ARBA FARMACISKAI PRIIMTINA JO DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2016)3293 20160526
2201840 2015/020 Ireland   Start Trial PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
2529621 122017000015 Germany   Start Trial PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945-C(2015)4704 20150703
2201840 92692 Luxembourg   Start Trial PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Moodys
Colorcon
Express Scripts
McKinsey

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 verification 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.