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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

International Patents:	151
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	101
Clinical Trials:	229
Patent Applications:	3,581
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for palbociclib
What excipients (inactive ingredients) are in palbociclib?	palbociclib excipients list
DailyMed Link:	palbociclib at DailyMed

Recent Clinical Trials for palbociclib

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

Sponsor	Phase
Washington University School of Medicine	Phase 3
Gustave Roussy, Cancer Campus, Grand Paris	Phase 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 Free	125MG	CAPSULE;ORAL
⤷ Try it Free	⤷ Try it Free	100MG	CAPSULE;ORAL
⤷ Try it Free	⤷ Try it Free	75MG	CAPSULE;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

Drug Class	Kinase Inhibitor
Mechanism of Action	Kinase Inhibitors Cytochrome P450 3A Inhibitors

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

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Glossary

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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

International Patents for palbociclib

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Country	Patent Number	Estimated Expiration
New Zealand	534069	⤷ Try it Free
Poland	2958916	⤷ Try it Free
Israel	240277	⤷ Try it Free
>Country	>Patent Number	>Estimated Expiration

Supplementary Protection Certificates for palbociclib

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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

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.