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Last Updated: May 6, 2021

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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 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 thirteen patent family members in fifty-four countries.

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

Summary for palbociclib
Recent Clinical Trials for palbociclib

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

SponsorPhase
EnhancedBio USA Inc.Phase 1/Phase 2
Sun Yat-sen UniversityPhase 2
Zenopharm LLCPhase 1/Phase 2

See all palbociclib clinical trials

Pharmacology for palbociclib
Paragraph IV (Patent) Challenges for PALBOCICLIB
Tradename Dosage Ingredient NDA Submissiondate
IBRANCE TABLET;ORAL palbociclib 212436 2020-11-24
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 TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-002 Nov 1, 2019 RX Yes No   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-003 Feb 3, 2015 RX Yes Yes   Get Started for $10   Get Started for $10   Get Started for $10
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes   Get Started for $10   Get Started for $10 Y Y   Get Started for $10
>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 1790011-9 Sweden   Get Started for $10 PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/16/1147 20161111
1470124 PA2017013,C1470124 Lithuania   Get Started for $10 PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124 CA 2017 00010 Denmark   Get Started for $10 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 333 9-2017 Slovakia   Get Started for $10 PRODUCT NAME: PALBOCIKLIB; REGISTRATION NO/DATE: EU/1/16/1147 20161111
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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