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Ibrutinib - Generic Drug Details

What are the generic drug sources for ibrutinib and what is the scope of ibrutinib patent protection?

Ibrutinib is the generic ingredient in one branded drug marketed by Pharmacyclics Inc and is included in two NDAs. There are twenty-eight patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Ibrutinib has two hundred and forty-one patent family members in thirty-eight countries.

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

Summary for ibrutinib

International Patents:	241
US Patents:	28
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	15
Suppliers / Packagers:	1
Bulk Api Vendors:	62
Clinical Trials:	244
Patent Applications:	384
Formulation / Manufacturing:	see details
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for ibrutinib
DailyMed Link:	ibrutinib at DailyMed

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]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 (BTK inhibitor)
Ibrutinib (JAN/USAN)
Ibrutinib (PCI-32765)
Ibrutinib (PCI32765)
Ibrutinib [USAN:INN]
Ibrutinib(PCI-32765)
Ibrutinib/PCI-32765
ibrutinibum
IMBRUVICA
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 ibrutinib

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

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Country	Document Number	Estimated Expiration
Colombia	7240408	➤ Sign Up
Portugal	2201840	➤ Sign Up
Israel	239156	➤ Sign Up
China	106102745	➤ Sign Up
Spain	2617150	➤ Sign Up
Country	Document Number	Estimated Expiration

Supplementary Protection Certificates for ibrutinib

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Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
692	Luxembourg	➤ Sign Up	PRODUCT NAME: IBRUTINIB, OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI. FIRST REGISTRATION: 20141023
/2015	Austria	➤ Sign Up	PRODUCT NAME: IBRUTINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ; REGISTRATION NO/DATE: EU/1/14/945 20141021
2015 00021	Denmark	➤ Sign Up	PRODUCT NAME: IBRUTINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; REG. NO/DATE: EU/1/14/945 20141021
0728	Netherlands	➤ Sign Up	DETAILS ASSIGNMENT: VERANDERING VAN EIGENAAR(S), SAMENVOEGEN
2015017	Lithuania	➤ Sign Up	PRODUCT NAME: IBRUTINIBUM; REGISTRATION NO/DATE: EU/1/14/945 20141021
Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description