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Generated: November 18, 2018

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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 twenty-seven patents protecting this drug and one Paragraph IV challenge.

The generic ingredient in IMBRUVICA is ibrutinib. There are fifteen 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
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.

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]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
AK133084
AKOS022185476
AMX10219
AN-1333
AOB87789
AX8254580
BDBM50357312
CHEBI:76612
CHEMBL1873475
CRA 032765
CRA-032765
D09KTS
D10223
DB09053
EBD2165770
EX-5960
EX-A066
FT-0696693
GTPL6912
HSDB 8260
HY-10997
Ibrutinib
Ibrutinib (BTK inhibitor)
Ibrutinib (JAN/USAN)
Ibrutinib (PCI-32765)
Ibrutinib (PCI32765)
Ibrutinib [USAN:INN]
Ibrutinib(PCI-32765)
Ibrutinib/PCI-32765
ibrutinibum
Imbruvica (TN)
J-523872
JNJ 02
KB-79777
KIN0000174
KS-000002KE
MFCD20261150
MLS006010041
MolPort-027-806-955
NCGC00187912-01
NCGC00187912-02
NCGC00187912-03
Pc-32765
PCI 32765
PCI-32765
PCI-32765 (Ibrutinib)
PCI-32765-00
PCI-32765(Ibrutinib)
PCI32765
QC-4573
S-7810
SC-96633
SCHEMBL201859
SMR004701213
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 ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-003 Feb 16, 2018 RX Yes No ➤ 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 ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-002 Feb 16, 2018 RX Yes No ➤ Sign Up ➤ Sign Up ➤ Sign Up
Pharmacyclics Inc IMBRUVICA ibrutinib TABLET;ORAL 210563-001 Feb 16, 2018 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 TABLET;ORAL 210563-004 Feb 16, 2018 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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Paragraph IV (Patent) Challenges for IMBRUVICA
Drugname Dosage Strength RLD Date
➤ Subscribe Capsules 140 mg ➤ Subscribe ➤ Sign Up

Supplementary Protection Certificates for IMBRUVICA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2017009 Lithuania ➤ Sign Up PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 C(2015)4704 20170703
2017 00012 Denmark ➤ Sign Up PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2015)4704 20150707
0868 Netherlands ➤ Sign Up PRODUCT NAME: IBRUTINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/14/945 - C(2015)4704 20150707
2015 00021 Denmark ➤ Sign Up PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
692 Luxembourg ➤ Sign Up PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
2015017 Lithuania ➤ Sign Up PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
/2015 Austria ➤ Sign Up PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; 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:

Chinese Patent Office
Teva
Covington
Harvard Business School
Accenture
Deloitte
Healthtrust
Merck
McKesson

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