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Last Updated: October 20, 2019

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Palbociclib - Generic Drug Details

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

Palbociclib is the generic ingredient in one branded drug marketed by Pfizer Inc and is included in one NDA. There are three patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Palbociclib has seventy-two patent family members in forty-nine countries.

There are thirteen drug master file entries for palbociclib. Two suppliers are listed for this compound.

Recent Clinical Trials for palbociclib

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

SponsorPhase
Hoffmann-La RochePhase 3
Shengjing HospitalPhase 3
Abramson Cancer Center of the University of PennsylvaniaPhase 1

See all palbociclib clinical trials

Recent Litigation for palbociclib

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Mylan Pharmaceuticals Inc.2019-04-25

See all palbociclib litigation

Pharmacology for palbociclib
Synonyms for palbociclib
190P302
2euf
2euf; PD 0332991
571190-30-2
571190-30-2 pound not827022-32-2
6-acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one
6-Acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-one
6-acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-8h-pyrido[2,3-d]pyrimidin-7-one hydrochloride
6-Acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-ylpyridin-2-ylamino)-8H-pyrido(2,3-d)pyrimidin-7-one
6-acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-yl-2-pyridyl)amino]pyrido[2,3-d]pyrimidin-7-one
6-acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino] pyrido[2,3-d]pyrimidin-7-one
6-acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrido[2,3-d]pyrimidin-7-one
6-ACETYL-8-CYCLOPENTYL-5-METHYL-2-[(5-PIPERAZIN-1-YLPYRIDIN-2-YL)AMINO]PYRIDO[2,3-D]PYRIMIDIN-7(8H)-ONE
6-acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrido[6,5-d]pyrimidin-7-one
6-Acetyl-8-cyclopentyl-5-methyl-2-[[5-(piperazin-1-yl)pyridin-2-yl]amino]-8H-pyrido[2,3-d]pyrimidin-7-one
6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H,8H-pyrido[2,3-d]pyrimidin-7-one
6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one
8-cyclopentyl-6-acetyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H,8H-pyrido[2,3-d]pyrimidin-7-one
A1-04309
ABP000842
AC-25485
AC1NS8RV
AHJRHEGDXFFMBM-UHFFFAOYSA-N
AK173631
AKOS022205241
AN-16841
AOB87334
AS-17016
AX8167187
BC654107
BCP09274
BCP9001058
BCPP000125
BDBM6309
BRD-K51313569-001-01-1
C24H29N7O2
CA10003
CHEBI:85993
CHEMBL189963
D10372
DB09073
EBD24067
EX-A408
FT-0697059
G9ZF61LE7G
GTPL7380
HMS3265M09
HMS3265M10
HMS3265N09
HMS3265N10
HY-50767
Ibrance
Ibrance (TN)
KB-79781
KIN0000560
Kinome_3823
Kinome_3824
LQQ
MFCD11840850
MolPort-009-679-393
NCGC00263129-01
NCGC00263129-21
OTAVA-BB 1115529
P-0332991
Palbociclib (JAN/USAN)
Palbociclib [USAN:INN]
Palbociclib free base
Palbociclib(PD0332991)
PD 0332991
PD 0332991,PD0332991
PD 332991
PD 332991, PD 0332991, 827022-32-2
PD-033299
PD-0332991
PD-0332991, PD0332991
PD-0332991/PD0332991,PD332991
PD-332991
PD0332991
PubChem16671
Pyrido-[2,3-d]-pyrimidin-7-one 43
Pyrido(2,3-d)pyrimidin-7(8H)-one, 6-acetyl-8-cyclopentyl-5-methyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)-
QCR-200
S14-2748
SC-92588
SCHEMBL462630
UNII-G9ZF61LE7G
X7379
Z-3143
ZINC3938686

US Patents and Regulatory Information for palbociclib

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-003 Feb 3, 2015 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-001 Feb 3, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-001 Feb 3, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for palbociclib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1470124 C 2017 016 Romania   Start Trial PRODUCT NAME: PALBOCICLIB OPTIONAL SUB FORMA DE SARE, ESTER, AMIDA SAUPROMEDICAMENT AL ACESTUIA, ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/16/1147; DATE OF NATIONAL AUTHORISATION: 20161109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1147; DATE OF FIRST AUTHORISATION IN EEA: 20161109
1470124 LUC00009 Luxembourg   Start Trial PRODUCT NAME: PALBOCICLIB, EVENTUELLEMENT SOUS LA FORME D'UN SEL , D'UN ESTER, D'UN AMIDE OU D'UN PROMEDICAMENT PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; AUTHORISATION NUMBER AND DATE: EU/1/16/1147 20161111
1470124 2017/009 Ireland   Start Trial PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESTER, AMIDE OR PRODRUG THEREOF; REGISTRATION NO/DATE: EU/1/16/1147/001 EU/1/16/1147/006 20161109
1470124 300863 Netherlands   Start Trial PRODUCT NAME: PALBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1147 20161111
1470124 C20170012 00212 Estonia   Start Trial PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124 17C1012 France   Start Trial PRODUCT NAME: PALBOCICLIB, ET TOUTES SES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE.; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124 C01470124/01 Switzerland   Start Trial PRODUCT NAME: PALBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66138 31.01.2017
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Dow
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.