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Last Updated: December 12, 2019

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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 one NDA. There are three 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 3rd, 2019.

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

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch.

Drug patent expirations by year for IBRANCE
Drug Prices for IBRANCE

See drug prices for IBRANCE

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

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 CAPSULE;ORAL 207103-001 Feb 3, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-003 Feb 3, 2015 RX Yes Yes   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 207103-002 Feb 3, 2015 RX Yes No   Start Trial   Start Trial   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 12/2017 Austria   Start Trial PRODUCT NAME: PALBOCICLIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, ESTERS, AMIDS ODER PRODRUGS DAVON; REGISTRATION NO/DATE: EU/1/16/1147/001-006 (MITTEILUNG) 20161111
1470124 122017000014 Germany   Start Trial PRODUCT NAME: PALBOCICLIB, OPTIONAL IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, ESTERS, AMIDES ODER EINES PRODRUGS HIERVON; REGISTRATION NO/DATE: EU/1/16/1147 20161109
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 PA2017013 Lithuania   Start Trial PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ESTERIO, AMIDO ARBA PROVAISTO PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

McKinsey
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Baxter
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Express Scripts
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