IBRANCE Drug Patent Profile

When do Ibrance patents expire, and when can generic versions of Ibrance launch?

Ibrance is a drug marketed by Pfizer and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

The generic ingredient in IBRANCE is palbociclib. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.

DrugPatentWatch^® Generic Entry Outlook for Ibrance

Ibrance was eligible for patent challenges on February 3, 2019.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 8, 2034. This may change due to patent challenges or generic licensing.

There have been forty-one patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

There are nine tentative approvals for the generic drug (palbociclib), which indicates the potential for near-term generic launch.

Indicators of Generic Entry

Summary for IBRANCE

US Patents:	3
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	128
Patent Applications:	5,469
Drug Prices:	Drug price information for IBRANCE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for IBRANCE
What excipients (inactive ingredients) are in IBRANCE?	IBRANCE excipients list
DailyMed Link:	IBRANCE at DailyMed

See drug prices for IBRANCE

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for IBRANCE

NDA:

207103

Dosage:

CAPSULE;ORAL

NDA:

212436

Dosage:

TABLET;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for IBRANCE

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

Sponsor	Phase
University Medical Center Groningen	Phase 4
Megalabs	PHASE4
AstraZeneca	Phase 1/Phase 2

See all IBRANCE clinical trials

Pharmacology for IBRANCE

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

Paragraph IV (Patent) Challenges for IBRANCE

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 IBRANCE

IBRANCE is protected by three US patents and three FDA Regulatory Exclusivities.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Expired US Patents for IBRANCE

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

EU/EMA Drug Approvals for IBRANCE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Pfizer Europe MA EEIG	Ibrance	palbociclib	EMEA/H/C/003853Ibrance 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 IBRANCE

When does loss-of-exclusivity occur for IBRANCE?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

Costa Rica

Croatia

Cyprus

Denmark

Dominican Republic

Ecuador

European Patent Office

Hong Kong

Hungary

Israel

Japan

Lithuania

Mexico

New Zealand

Peru

Poland

Portugal

Russian Federation

Saudi Arabia

Serbia

Singapore

Slovenia

South Africa

South Korea

Spain

Taiwan

Turkey

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering IBRANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Argentina	094842
Australia	2014220354
Brazil	112015019508
Canada	2900322
China	105008357
China	107759594
China	111253394

Supplementary Protection Certificates for IBRANCE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1470124	300863	Netherlands		PRODUCT NAME: PALBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1147 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	PA2017013	Lithuania		PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ESTERIO, AMIDO ARBA PROVAISTO PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124	C20170012 00212	Estonia		PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124	CA 2017 00010	Denmark		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	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	LUC00009	Luxembourg		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

DrugChatter Q&A for IBRANCE

Pfizer ibrance manufactured where?
Ibrance patent expiry 2027 us?
Pfizer ibrance patent expiration us?
Ibrance generic?
What are the side effects of ibrance?