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Last Updated: May 25, 2022

IBRANCE Drug Patent Profile


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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 six patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and fifty-nine patent family members in fifty-five countries.

The generic ingredient in IBRANCE is palbociclib. There are thirteen drug master file entries for this compound. Three 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 February 8, 2034. This may change due to patent challenges or generic licensing.

There have been six 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.

Indicators of Generic Entry

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Drug patent expirations by year for IBRANCE
Drug Prices for IBRANCE

See drug prices for IBRANCE

DrugPatentWatch® Estimated Generic Entry Opportunity Date for IBRANCE
Generic Entry Dates for IBRANCE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for IBRANCE*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Bradley A. McGregorPhase 2
OHSU Knight Cancer InstitutePhase 2
Oregon Health and Science UniversityPhase 2

See all IBRANCE clinical trials

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 seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IBRANCE is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

Patents protecting IBRANCE

Solid forms of a selective CDK4/6 inhibitor
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Solid dosage forms of palbociclib
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: TREATING HR-POS., HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER WITH PALBOCICLIB IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE BASED THERAPY IN POSTMENOPAUSAL WOMEN OR FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY

2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
Patented Use: PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY

2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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

Patent: 4842
Estimated Expiration: See Plans and Pricing

Patent: 4909
Estimated Expiration: See Plans and Pricing

Australia

Patent: 14220354
Estimated Expiration: See Plans and Pricing

Patent: 16272881
Estimated Expiration: See Plans and Pricing

Patent: 19204689
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 2015019508
Estimated Expiration: See Plans and Pricing

Patent: 2017025398
Estimated Expiration: See Plans and Pricing

Canada

Patent: 00322
Estimated Expiration: See Plans and Pricing

Patent: 31892
Estimated Expiration: See Plans and Pricing

Chile

Patent: 17003089
Estimated Expiration: See Plans and Pricing

China

Patent: 5008357
Estimated Expiration: See Plans and Pricing

Patent: 7666914
Estimated Expiration: See Plans and Pricing

Patent: 7759594
Estimated Expiration: See Plans and Pricing

Patent: 1253394
Estimated Expiration: See Plans and Pricing

Patent: 3616606
Estimated Expiration: See Plans and Pricing

Colombia

Patent: 17012362
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 170540
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0192065
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 20734
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 58916
Estimated Expiration: See Plans and Pricing

Patent: 02565
Estimated Expiration: See Plans and Pricing

Patent: 31475
Estimated Expiration: See Plans and Pricing

Dominican Republic

Patent: 017000280
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 17085737
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 58916
Estimated Expiration: See Plans and Pricing

Patent: 02565
Estimated Expiration: See Plans and Pricing

Patent: 31475
Estimated Expiration: See Plans and Pricing

Patent: 36283
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 11032
Estimated Expiration: See Plans and Pricing

Patent: 48217
Estimated Expiration: See Plans and Pricing

Patent: 50570
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 40434
Estimated Expiration: See Plans and Pricing

Patent: 47477
Estimated Expiration: See Plans and Pricing

Patent: 54212
Estimated Expiration: See Plans and Pricing

Israel

Patent: 0277
Estimated Expiration: See Plans and Pricing

Patent: 5632
Estimated Expiration: See Plans and Pricing

Patent: 7437
Estimated Expiration: See Plans and Pricing

Japan

Patent: 81016
Estimated Expiration: See Plans and Pricing

Patent: 24152
Estimated Expiration: See Plans and Pricing

Patent: 14162794
Estimated Expiration: See Plans and Pricing

Patent: 17002034
Estimated Expiration: See Plans and Pricing

Patent: 17186376
Estimated Expiration: See Plans and Pricing

Patent: 19116512
Estimated Expiration: See Plans and Pricing

Patent: 21167343
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 02565
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 3715
Estimated Expiration: See Plans and Pricing

Patent: 15010858
Estimated Expiration: See Plans and Pricing

Patent: 17015579
Estimated Expiration: See Plans and Pricing

Patent: 19003605
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0138
Estimated Expiration: See Plans and Pricing

Peru

Patent: 180395
Estimated Expiration: See Plans and Pricing

Poland

Patent: 58916
Estimated Expiration: See Plans and Pricing

Patent: 02565
Estimated Expiration: See Plans and Pricing

Patent: 31475
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 58916
Estimated Expiration: See Plans and Pricing

Patent: 02565
Estimated Expiration: See Plans and Pricing

Patent: 31475
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 19944
Estimated Expiration: See Plans and Pricing

Patent: 86840
Estimated Expiration: See Plans and Pricing

Patent: 15132371
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 672
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 201505680R
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 58916
Estimated Expiration: See Plans and Pricing

Patent: 02565
Estimated Expiration: See Plans and Pricing

Patent: 31475
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 1707780
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1858913
Estimated Expiration: See Plans and Pricing

Patent: 2068423
Estimated Expiration: See Plans and Pricing

Patent: 2369405
Estimated Expiration: See Plans and Pricing

Patent: 150107872
Estimated Expiration: See Plans and Pricing

Patent: 170094012
Estimated Expiration: See Plans and Pricing

Patent: 180015232
Estimated Expiration: See Plans and Pricing

Patent: 200006633
Estimated Expiration: See Plans and Pricing

Spain

Patent: 94787
Estimated Expiration: See Plans and Pricing

Patent: 64459
Estimated Expiration: See Plans and Pricing

Patent: 69277
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 33103
Estimated Expiration: See Plans and Pricing

Patent: 35863
Estimated Expiration: See Plans and Pricing

Patent: 70269
Estimated Expiration: See Plans and Pricing

Patent: 1444834
Estimated Expiration: See Plans and Pricing

Patent: 1711687
Estimated Expiration: See Plans and Pricing

Patent: 1803872
Estimated Expiration: See Plans and Pricing

Patent: 1906611
Estimated Expiration: See Plans and Pricing

Turkey

Patent: 1816077
Estimated Expiration: See Plans and Pricing

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
Denmark 3431475 See Plans and Pricing
Ecuador SP105201 2-(PIRIDIN-2-ILAMINO)-PIRIDO[2,3-d] PIRIMIDIN-7-ONAS See Plans and Pricing
Japan 6381016 See Plans and Pricing
Israel 162721 2-(PYRIDIN-2-YLAMINO)-PYRIDO[2,3-d]PYRIMIDIN-7-ONES See Plans and Pricing
Poland 2958916 See Plans and Pricing
Poland 372046 See Plans and Pricing
China 102295643 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IBRANCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1470124 PA2017013,C1470124 Lithuania See Plans and Pricing PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124 CA 2017 00010 Denmark See Plans and Pricing 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 132017000046148 Italy See Plans and Pricing 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 PA2017013 Lithuania See Plans and Pricing PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ESTERIO, AMIDO ARBA PROVAISTO PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124 333 9-2017 Slovakia See Plans and Pricing PRODUCT NAME: PALBOCIKLIB; REGISTRATION NO/DATE: EU/1/16/1147 20161111
1470124 300863 Netherlands See Plans and Pricing PRODUCT NAME: PALBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1147 20161111
1470124 CR 2017 00010 Denmark See Plans and Pricing 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.