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Last Updated: October 23, 2021

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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 six 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 fifty-one patent family members in fifty-five countries.

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

Summary for palbociclib
Recent Clinical Trials for palbociclib

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

SponsorPhase
Washington University School of MedicinePhase 3
Gustave Roussy, Cancer Campus, Grand ParisPhase 2
Ascentage Pharma Group Inc.Phase 1/Phase 2

See all palbociclib clinical trials

Generic filers with tentative approvals for PALBOCICLIB
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free125MGCAPSULE;ORAL
⤷  Try it Free⤷  Try it Free100MGCAPSULE;ORAL
⤷  Try it Free⤷  Try it Free75MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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 212436-001 Nov 1, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-002 Nov 1, 2019 RX Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 LUC00009 Luxembourg ⤷  Try it Free 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 PA2017013 Lithuania ⤷  Try it Free PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ESTERIO, AMIDO ARBA PROVAISTO PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124 CR 2017 00010 Denmark ⤷  Try it Free 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

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

Serving leading biopharmaceutical companies globally:

Baxter
Harvard Business School
AstraZeneca
Express Scripts
Johnson and Johnson
Colorcon

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