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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-four patents protecting this drug and one Paragraph IV challenge.

This drug has two hundred and twenty-five patent family members in thirty-eight countries.

The generic ingredient in IMBRUVICA is ibrutinib. There are thirteen 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:	225
US Patents:	24
Applicants:	1
NDAs:	2
Suppliers / Packagers:	1
Bulk Api Vendors:	62
Clinical Trials:	88
Patent Applications:	250
Formulation / Manufacturing:	see details
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]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
Pharmacyclics Inc	IMBRUVICA	ibrutinib	TABLET;ORAL	210563-003	Feb 16, 2018		RX	Yes	No			Y
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

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Paragraph IV (Patent) Challenges for IMBRUVICA

Drugname	Dosage	Strength	RLD	Date
	Capsules	140 mg

Non-Orange Book US Patents for IMBRUVICA

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
9,079,908	Inhibitors of Bruton'S tyrosine kinase
9,828,383	Crystalline forms of a bruton's tyrosine kinase inhibitor
8,759,516	Inhibitors of Bruton's tyrosine kinase
8,232,280	Inhibitors of bruton'S tyrosine kinase

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International Patents for IMBRUVICA

Country	Document Number	Estimated Expiration
Singapore	11201707122Q
Cyprus	1117897
Denmark	2526933
European Patent Office	2526934

Supplementary Protection Certificates for IMBRUVICA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2016 00056	Denmark		PRODUCT NAME: IBRUTINIB, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 C(2016)3293 20160530
2015017,C2201840	Lithuania		PRODUCT NAME: IBRUTINIBAS ARBA JO FARMACINIU POZIURIU PRIIMTINA DRUSKA; REGISTRATION NO/DATE: EU/1/14/945 20141021
2016000093	Germany		PRODUCT NAME: LBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON; REGISTRATION NO/DATE: EU/1/14/945 20160526
0150014 00145	Estonia		PRODUCT NAME: IBRUTINIIB;REG NO/DATE: EU/1/14/945 23.10.2014