Palbociclib - Generic Drug Details

What are the generic sources for palbociclib and what is the scope of freedom to operate?

Palbociclib is the generic ingredient in two branded drugs marketed by Pfizer and Synthon Pharms Inc, and is included in three 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:	2
Applicants:	2
NDAs:	3
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
		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

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

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	207103-001	Feb 3, 2015		RX	Yes	No			Y	Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015		RX	Yes	No			Y	Y
Pfizer	IBRANCE	palbociclib	TABLET;ORAL	212436-003	Nov 1, 2019	AB	RX	Yes	Yes			Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-003	Feb 3, 2015		RX	Yes	Yes			Y	Y
Pfizer	IBRANCE	palbociclib	CAPSULE;ORAL	207103-002	Feb 3, 2015		RX	Yes	No			Y	Y
Synthon Pharms Inc	PALBOCICLIB	palbociclib	TABLET;ORAL	215570-003	Jun 5, 2024	AB	RX	No	No

Expired US Patents for palbociclib

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

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
Japan	2021167343	パルボシクリブの固形剤形 (SOLID DOSAGE FORM OF PALBOCICLIB)
Montenegro	00230	2-(PIRIDIN -2-ILAMINO)-PIRIDO(2,3-D) PIRIMIDIN-7-ONI (2-(PYRIDIN-2-YLAMINO)-PYRIDO 2,3-d]PYRIMIDIN-7-ONES)
Spain	2764459
World Intellectual Property Organization (WIPO)	03062236
Israel	240277	צורות מוצקות של מעכב סלקטיבי של cdk4/6 (Solid forms of a selective cdk4/6 inhibitor)
Hong Kong	1248217	選擇性CDK4/6抑制劑的固態形式 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR)

Supplementary Protection Certificates for palbociclib

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	PA2017013	Lithuania		PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ESTERIO, AMIDO ARBA PROVAISTO PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124	C01470124/01	Switzerland		PRODUCT NAME: PALBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66138 31.01.2017
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	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