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 three 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 sixty-six patent family members in fifty-six countries.

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

Summary for PALBOCICLIB

International Patents:	166
US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	114
Clinical Trials:	296
Patent Applications:	3,386
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
University Medical Center Groningen	Phase 4
Mohammed Milhem	Phase 1
AstraZeneca	Phase 1/Phase 2

See all PALBOCICLIB clinical trials

Generic filers with tentative approvals for PALBOCICLIB

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	125MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	100MG	CAPSULE;ORAL
⤷ Sign Up	⤷ Sign Up	125MG	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	Cytochrome P450 3A Inhibitors Kinase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PALBOCICLIB

L01EF	Cyclin-dependent kinase (CDK) inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

Paragraph IV (Patent) Challenges for PALBOCICLIB

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
IBRANCE	Tablets	palbociclib	75 mg, 100 mg and 125 mg	212436	1	2020-11-24
IBRANCE	Capsules	palbociclib	75 mg, 100 mg and 125 mg	207103	12	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	CAPSULE;ORAL	207103-002	Feb 3, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015		RX	Yes	Yes	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019		RX	Yes	No	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for PALBOCICLIB

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019	⤷ Sign Up	⤷ Sign Up
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-001	Nov 1, 2019	⤷ Sign Up	⤷ Sign Up
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015	⤷ Sign Up	⤷ Sign Up
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015	⤷ Sign Up	⤷ Sign Up
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019	⤷ Sign Up	⤷ Sign Up
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015	⤷ Sign Up	⤷ Sign Up
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

EU/EMA Drug Approvals for PALBOCICLIB

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Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Ibrance	palbociclib	EMEA/H/C/003853 Ibrance is indicated for the treatment of hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer:in combination with an aromatase inhibitor;in combination with fulvestrant in women who have received prior endocrine therapy.In pre- or perimenopausal women, the endocrine therapy should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.	Authorised	no	no	no	2016-11-09
>Company	>Drugname	>Inn	>Product Number / Indication	>Status	>Generic	>Biosimilar	>Orphan	>Marketing Authorisation	>Marketing Refusal

International Patents for PALBOCICLIB

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Country	Patent Number	Title	Estimated Expiration
Norway	20043484		⤷ Sign Up
Brazil	112015019508	formas sólidas de um inibidor de cdk4/6 seletivo	⤷ Sign Up
Taiwan	201444834	Solid forms of a selective CDK4/6 inhibitor	⤷ Sign Up
China	101001857		⤷ Sign Up
Denmark	1470124		⤷ Sign Up
Hong Kong	1248217	選擇性CDK4/6抑制劑的固態形式 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR)	⤷ Sign Up
Japan	2023112149	パルボシクリブの固形剤形 (SOLID DOSAGE FORM OF PALBOCICLIB)	⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for PALBOCICLIB

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	C20170012 00212	Estonia	⤷ Sign Up	PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124	132017000046148	Italy	⤷ Sign Up	PRODUCT NAME: PALBOCICLIB, OPZIONALMENTE NELLA FORMA DI UN SALE, ESTERE, AMMIDE O PROFARMACO FARMACEUTICAMENTE ACCETTABILE(IBRANCE); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/16/1147/001-006, 20161111
1470124	12/2017	Austria	⤷ Sign Up	PRODUCT NAME: PALBOCICLIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, ESTERS, AMIDS ODER PRODRUGS DAVON; REGISTRATION NO/DATE: EU/1/16/1147/001-006 (MITTEILUNG) 20161111
1470124	LUC00009	Luxembourg	⤷ Sign Up	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	300863	Netherlands	⤷ Sign Up	PRODUCT NAME: PALBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1147 20161111
1470124	CA 2017 00010	Denmark	⤷ Sign Up	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	⤷ Sign Up	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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