Palbociclib - Generic Drug Details

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 sixty-two patent family members in fifty-five countries.

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

Summary for palbociclib

International Patents:	162
US Patents:	6
Tradenames:	1
Applicants:	1
NDAs:	2
Drug Master File Entries:	13
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	106
Clinical Trials:	268
Patent Applications:	5,035
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
Seoul National University Hospital	Phase 2
Stemline Therapeutics, Inc.	Phase 1/Phase 2
Thomas Jefferson University	Phase 1

See all palbociclib clinical trials

Generic filers with tentative approvals for PALBOCICLIB

Applicant	Application No.	Strength	Dosage Form
		125MG	CAPSULE;ORAL
		100MG	CAPSULE;ORAL
		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

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

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	212436-002	Nov 1, 2019		RX	Yes	No			Y	Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019		RX	Yes	Yes			Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015		RX	Yes	No			Y	Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-002	Nov 1, 2019		RX	Yes	No
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-001	Feb 3, 2015		RX	Yes	No			Y	Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015		RX	Yes	Yes			Y	Y

Expired US Patents for palbociclib

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

EU/EMA Drug Approvals for palbociclib

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

International Patents for palbociclib

Country	Patent Number	Title	Estimated Expiration
Taiwan	200302224
Japan	2019116512	選択的ＣＤＫ４／６阻害剤の固体形態 (SOLID FORM OF SELECTIVE CDK4/6 INHIBITOR)
Brazil	112017025398	formas de dosagem sólidas de palbociclib
Argentina	038814	COMPUESTOS DE 2-(PIRIDIN-2-ILAMINO)-PIRIDO[2,3-D]PIRIMIDIN-7-ONA Y USO EN LA FABRICACION DE MEDICAMENTOS
Colombia	5700765	2-(PIRIDIN-2-ILAMINO)-PIRIDO[2,3-D] PIRIMIDIN-7-ONAS
Brazil	PI0307057	compostos 2-(piridin-2-ilamino)-pirido[2,3-d]pirimidin-7-onas

Supplementary Protection Certificates for palbociclib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	C 2017 016	Romania		PRODUCT NAME: PALBOCICLIB OPTIONAL SUB FORMA DE SARE, ESTER, AMIDA SAUPROMEDICAMENT AL ACESTUIA, ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/16/1147; DATE OF NATIONAL AUTHORISATION: 20161109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1147; DATE OF FIRST AUTHORISATION IN EEA: 20161109
1470124	12/2017	Austria		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	122017000014	Germany		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	132017000046148	Italy		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	C20170012 00212	Estonia		PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124	SPC/GB17/026	United Kingdom		PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESTER, AMIDE OR PRODRUG THEREOF; REGISTERED: UK EU/1/16/1147 20161109; UK FURTHER MAS ON IPSUM 20161109