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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-four patents protecting this drug and four Paragraph IV challenges.

This drug has two hundred and eighty-one 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.

US ANDA Litigation and Generic Entry Outlook for Imbruvica

Imbruvica was eligible for patent challenges on November 13, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be October 30, 2033. This may change due to patent challenges or generic licensing.

There have been eight patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Summary for IMBRUVICA

International Patents:	281
US Patents:	34
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	68
Clinical Trials:	117
Patent Applications:	350
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for IMBRUVICA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IMBRUVICA
DailyMed Link:	IMBRUVICA at DailyMed

Drug patent expirations by year for IMBRUVICA

Generic Entry Opportunity Date for IMBRUVICA

Generic Entry Dates for IMBRUVICA^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 205552 Dosage: CAPSULE;ORAL
Generic Entry Dates for IMBRUVICA^: Start Trial* Constraining patent/regulatory exclusivity: Start Trial NDA: 210563 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

Sponsor	Phase
Eli Lilly and Company	Phase 1
TG Therapeutics, Inc.	Phase 2
Kerry Rogers	Phase 2

See all IMBRUVICA clinical trials

Recent Litigation for IMBRUVICA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Pharmacyclics LLC v. Alvogen Pine Brook LLC	2019-03-01
Pharmacyclics LLC v. Zydus Worldwide DMCC	2019-01-28
Pharmacyclics LLC v. Hetero USA Inc.	2019-01-04

See all IMBRUVICA litigation

PTAB Litigation

Petitioner	Date
Sandoz Inc.	2019-03-21
Coalition for Affordable Drugs IV LLC	2015-04-20

See all IMBRUVICA litigation

Pharmacology for IMBRUVICA

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein 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

Paragraph IV (Patent) Challenges for IMBRUVICA

Tradename	Dosage	Ingredient	NDA	Submissiondate
IMBRUVICA	TABLET;ORAL	ibrutinib	210563	2018-12-14
IMBRUVICA	CAPSULE;ORAL	ibrutinib	205552	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 IMBRUVICA

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Glossary

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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	210563-003	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				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	TABLET;ORAL	210563-004	Feb 16, 2018		RX	Yes	Yes	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

International Patents for IMBRUVICA

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Country	Patent Number	Estimated Expiration
Israel	239156	Start Trial
Australia	2014339815	Start Trial
China	106102745	Start Trial
Hong Kong	1140107	Start Trial
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for IMBRUVICA

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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
2201840	C20150014 00145	Estonia	Start Trial	PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014
2529621	C20170010 00279	Estonia	Start Trial	PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 07.07.2015
2201840	CA 2015 00021	Denmark	Start Trial	PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description