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

This drug has two hundred and fifty-nine patent family members in thirty-eight 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.

Summary for IMBRUVICA

International Patents:	259
US Patents:	29
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	65
Clinical Trials:	111
Patent Applications:	264
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

Generic Entry Opportunity Date for IMBRUVICA

NDA:

205552

Dosage:

CAPSULE;ORAL

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.

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

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	TABLET;ORAL	210563-004	Feb 16, 2018		RX	Yes	Yes			Y	Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No			Y	Y
Pharmacyclics Inc	IMBRUVICA	ibrutinib	CAPSULE;ORAL	205552-001	Nov 13, 2013		RX	Yes	Yes
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-001	Feb 16, 2018		RX	Yes	No
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-004	Feb 16, 2018		RX	Yes	Yes

Paragraph IV (Patent) Challenges for IMBRUVICA

Drugname	Dosage	Strength	RLD	Date
	Tablets	280 mg and 420 mg
	Tablets	140 mg and 560 mg
	Capsules	70 mg
	Capsules	140 mg

International Patents for IMBRUVICA

Country	Patent Number	Estimated Expiration
Brazil	PI0622054
Lithuania	2529621
China	106102745
Costa Rica	20140558
Luxembourg	93321
China	101610676

Supplementary Protection Certificates for IMBRUVICA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2201840	2015/020	Ireland		PRODUCT NAME: IBRUTINIB, OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/14/945 20141021
2201840	300728	Netherlands		DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN
2529621	122017000015	Germany		PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945-C(2015)4704 20150703
2201840	CR 2015 00021	Denmark		PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141023
2201840	233 5006-2015	Slovakia		PRODUCT NAME: IBRUTINIB; REGISTRATION NO/DATE: EU/1/14/945 20141023
2529621	LUC00011	Luxembourg		PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/14/945 20150707