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Last Updated: October 28, 2020

DrugPatentWatch Database Preview

Palbociclib - Generic Drug Details

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What are the generic drug sources for palbociclib and what is the scope of freedom to operate?

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

Palbociclib has one hundred and eleven patent family members in fifty-four countries.

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

Recent Clinical Trials for palbociclib

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

SponsorPhase
Stanford UniversityPhase 1
Breast Cancer Research FoundationPhase 1
QED Therapeutics, Inc.Phase 1

See all palbociclib clinical trials

Pharmacology for palbociclib
Paragraph IV (Patent) Challenges for PALBOCICLIB
Tradename Dosage Ingredient NDA Submissiondate
IBRANCE CAPSULE;ORAL palbociclib 207103 2019-02-04

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 IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-002 Nov 1, 2019 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-001 Feb 3, 2015 RX Yes No   Start Trial   Start Trial Y Y   Start Trial
Pfizer 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 palbociclib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 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
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 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
AstraZeneca
Express Scripts
Johnson and Johnson
Colorcon

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