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Last Updated: February 17, 2020

DrugPatentWatch Database Preview

IBRANCE Drug Profile


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Which patents cover Ibrance, and what generic alternatives are available?

Ibrance is a drug marketed by Pfizer Inc and is included in two NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

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

The generic ingredient in IBRANCE is palbociclib. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.

US ANDA Litigation and Generic Entry Outlook for Ibrance

Ibrance was eligible for patent challenges on February 3, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 22, 2023. This may change due to patent challenges or generic licensing.

There have been two patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for IBRANCE
Drug Prices for IBRANCE

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Generic Entry Opportunity Date for IBRANCE
Generic Entry Dates for IBRANCE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for IBRANCE*:
Constraining patent/regulatory exclusivity:
NDA:
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.

Recent Clinical Trials for IBRANCE

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

SponsorPhase
PfizerEarly Phase 1
SOLTI Breast Cancer Research GroupEarly Phase 1
Shengjing HospitalPhase 3

See all IBRANCE clinical trials

Recent Litigation for IBRANCE

Identify potential future generic entrants

District Court Litigation
Case NameDate
Pfizer Inc. v. Mylan Pharmaceuticals Inc.2019-04-25
Pfizer Inc. v. Aizant Drug Research Solutions Pvt. Ltd.2019-04-25

See all IBRANCE litigation

Pharmacology for IBRANCE
Synonyms for IBRANCE
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 (TN)
KB-79781
KIN0000560
Kinome_3823
Kinome_3824
LQQ
MFCD11840850
MolPort-009-679-393
NCGC00263129-01
NCGC00263129-21
OTAVA-BB 1115529
P-0332991
Palbociclib
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
Paragraph IV (Patent) Challenges for IBRANCE
Tradename Dosage Ingredient NDA Submissiondate
IBRANCE CAPSULE;ORAL palbociclib 207103 2019-02-04

US Patents and Regulatory Information for IBRANCE

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 TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes   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 207103-003 Feb 3, 2015 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer Inc IBRANCE palbociclib TABLET;ORAL 212436-002 Nov 1, 2019 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   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-001 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 IBRANCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 CA 2017 00010 Denmark   Start Trial PRODUCT NAME: PALBOCICLIB, EVENTUELT I FORM AF EN FARMACEUTISK ACCEPTABEL ESTER ELLER ET FARMACEUTISK ACCEPTABELT SALT, AMID ELLER PRODRUG; REG. NO/DATE: EU/1/16/1147/001-006 20161111
1470124 C20170012 00212 Estonia   Start Trial PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124 PA2017013,C1470124 Lithuania   Start Trial PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; 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
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 CR 2017 00010 Denmark   Start Trial PRODUCT NAME: PALBOCICLIB, EVENTUELT I FORM AF EN FARMACEUTISK ACCEPTABEL ESTER ELLER ET FARMACEUTISK ACCEPTABELT SALT, AMID ELLER PRODRUG; REG. NO/DATE: EU/1/16/1147/001-006 20161111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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