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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-one patent family members in forty countries.

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

Summary for ibrutinib

International Patents:	281
US Patents:	34
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	16
Suppliers / Packagers:	1
Bulk Api Vendors:	68
Clinical Trials:	284
Patent Applications:	485
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ibrutinib
DailyMed Link:	ibrutinib at DailyMed

Recent Clinical Trials for ibrutinib

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

Sponsor	Phase
Institute of Epidemiology and Medical Biometry, University of Ulm	Phase 3
ZKS Ulm (Zentrum für Klinische Studien Ulm)	Phase 3
Amgen	Phase 3

See all ibrutinib clinical trials

Recent Litigation for ibrutinib

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 ibrutinib litigation

PTAB Litigation

Petitioner	Date
	2019-03-21
	2015-04-20

See all ibrutinib litigation

Pharmacology for ibrutinib

Drug Class	Kinase Inhibitor
Mechanism of Action	Protein 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

Paragraph IV (Patent) Challenges for IBRUTINIB

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 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	205552-002	Dec 20, 2017		RX	Yes	No			Y	Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		RX	Yes	Yes
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-002	Dec 20, 2017		RX	Yes	No

International Patents for ibrutinib

Country	Patent Number	Estimated Expiration
Taiwan	I632912
Spain	2616789
China	102887900

Supplementary Protection Certificates for ibrutinib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2526934	CA 2016 00056	Denmark		PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
2201840	2015/020	Ireland		PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840	92692	Luxembourg		PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023