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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.

Summary for ibrutinib

International Patents:	272
US Patents:	32
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	16
Suppliers / Packagers:	1
Bulk Api Vendors:	68
Clinical Trials:	272
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
Janssen Research & Development, LLC	Phase 4
University College, London	Phase 2/Phase 3
Eli Lilly and Company	Phase 1

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
Sandoz Inc.	2019-03-21
Coalition for Affordable Drugs IV LLC	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

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
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes			Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-002	Feb 16, 2018		RX	Yes	No				Y

International Patents for ibrutinib

Country	Patent Number	Estimated Expiration
Israel	197550
Singapore	166093
South Korea	20090091115

Supplementary Protection Certificates for ibrutinib

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