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Last Updated: July 4, 2020

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Palbociclib - Generic Drug Details

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

Palbociclib is the generic ingredient in one branded drug marketed by Pfizer Inc and is included in two NDAs. There are four 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. Three suppliers are listed for this compound.

Recent Clinical Trials for palbociclib

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SponsorPhase
Breast Cancer NowPhase 1
Ulrik LassenPhase 2
GlaxoSmithKlinePhase 2

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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 Inc IBRANCE palbociclib TABLET;ORAL 212436-002 Nov 1, 2019 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 TABLET;ORAL 212436-001 Nov 1, 2019 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 palbociclib

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

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Serving leading biopharmaceutical companies globally:

Moodys
Medtronic
Dow
Baxter
Colorcon
Boehringer Ingelheim

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