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Last Updated: June 20, 2024

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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 three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and sixty-six patent family members in fifty-six countries.

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

There have been seventeen 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 six tentative approvals for the generic drug (palbociclib), which indicates the potential for near-term generic launch.

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 Loss of Exclusivity (LOE) 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
Relay Therapeutics, Inc.Phase 1
University of Michigan Rogel Cancer CenterPhase 4
Stemline Therapeutics, Inc.Phase 1/Phase 2

See all IBRANCE clinical trials

Pharmacology for IBRANCE
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.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of IBRANCE is ⤷  Sign Up.

This potential generic entry date is based on patent ⤷  Sign Up.

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: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

Solid dosage forms of palbociclib
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones
Patent Number: ⤷  Sign Up
Patent Expiration: ⤷  Sign Up

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 ⤷  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 207103-002 Feb 3, 2015 RX Yes No ⤷  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 ⤷  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 IBRANCE

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

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 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: ⤷  Sign Up

Patent: 4909
Estimated Expiration: ⤷  Sign Up

Australia

Patent: 14220354
Estimated Expiration: ⤷  Sign Up

Patent: 16272881
Estimated Expiration: ⤷  Sign Up

Patent: 19204689
Estimated Expiration: ⤷  Sign Up

Brazil

Patent: 2015019508
Estimated Expiration: ⤷  Sign Up

Patent: 2017025398
Estimated Expiration: ⤷  Sign Up

Canada

Patent: 00322
Estimated Expiration: ⤷  Sign Up

Patent: 31892
Estimated Expiration: ⤷  Sign Up

Chile

Patent: 17003089
Estimated Expiration: ⤷  Sign Up

China

Patent: 5008357
Estimated Expiration: ⤷  Sign Up

Patent: 7666914
Estimated Expiration: ⤷  Sign Up

Patent: 7759594
Estimated Expiration: ⤷  Sign Up

Patent: 1253394
Estimated Expiration: ⤷  Sign Up

Patent: 3616606
Estimated Expiration: ⤷  Sign Up

Colombia

Patent: 17012362
Estimated Expiration: ⤷  Sign Up

Costa Rica

Patent: 170540
Estimated Expiration: ⤷  Sign Up

Croatia

Patent: 0192065
Estimated Expiration: ⤷  Sign Up

Cyprus

Patent: 20734
Estimated Expiration: ⤷  Sign Up

Patent: 22454
Estimated Expiration: ⤷  Sign Up

Patent: 24068
Estimated Expiration: ⤷  Sign Up

Denmark

Patent: 58916
Estimated Expiration: ⤷  Sign Up

Patent: 02565
Estimated Expiration: ⤷  Sign Up

Patent: 31475
Estimated Expiration: ⤷  Sign Up

Dominican Republic

Patent: 017000280
Estimated Expiration: ⤷  Sign Up

Ecuador

Patent: 17085737
Estimated Expiration: ⤷  Sign Up

European Patent Office

Patent: 58916
Estimated Expiration: ⤷  Sign Up

Patent: 02565
Estimated Expiration: ⤷  Sign Up

Patent: 31475
Estimated Expiration: ⤷  Sign Up

Patent: 36283
Estimated Expiration: ⤷  Sign Up

Hong Kong

Patent: 11032
Estimated Expiration: ⤷  Sign Up

Patent: 48217
Estimated Expiration: ⤷  Sign Up

Patent: 50570
Estimated Expiration: ⤷  Sign Up

Hungary

Patent: 40434
Estimated Expiration: ⤷  Sign Up

Patent: 47477
Estimated Expiration: ⤷  Sign Up

Patent: 54212
Estimated Expiration: ⤷  Sign Up

Israel

Patent: 0277
Estimated Expiration: ⤷  Sign Up

Patent: 5632
Estimated Expiration: ⤷  Sign Up

Patent: 7437
Estimated Expiration: ⤷  Sign Up

Japan

Patent: 81016
Estimated Expiration: ⤷  Sign Up

Patent: 24152
Estimated Expiration: ⤷  Sign Up

Patent: 14162794
Estimated Expiration: ⤷  Sign Up

Patent: 17002034
Estimated Expiration: ⤷  Sign Up

Patent: 17186376
Estimated Expiration: ⤷  Sign Up

Patent: 19116512
Estimated Expiration: ⤷  Sign Up

Patent: 21167343
Estimated Expiration: ⤷  Sign Up

Patent: 23112149
Estimated Expiration: ⤷  Sign Up

Lithuania

Patent: 02565
Estimated Expiration: ⤷  Sign Up

Mexico

Patent: 3715
Estimated Expiration: ⤷  Sign Up

Patent: 15010858
Estimated Expiration: ⤷  Sign Up

Patent: 17015579
Estimated Expiration: ⤷  Sign Up

Patent: 19003605
Estimated Expiration: ⤷  Sign Up

Patent: 20003825
Estimated Expiration: ⤷  Sign Up

New Zealand

Patent: 0138
Estimated Expiration: ⤷  Sign Up

Patent: 7391
Estimated Expiration: ⤷  Sign Up

Peru

Patent: 180395
Estimated Expiration: ⤷  Sign Up

Poland

Patent: 58916
Estimated Expiration: ⤷  Sign Up

Patent: 02565
Estimated Expiration: ⤷  Sign Up

Patent: 31475
Estimated Expiration: ⤷  Sign Up

Portugal

Patent: 58916
Estimated Expiration: ⤷  Sign Up

Patent: 02565
Estimated Expiration: ⤷  Sign Up

Patent: 31475
Estimated Expiration: ⤷  Sign Up

Russian Federation

Patent: 19944
Estimated Expiration: ⤷  Sign Up

Patent: 86840
Estimated Expiration: ⤷  Sign Up

Patent: 15132371
Estimated Expiration: ⤷  Sign Up

Saudi Arabia

Patent: 7390473
Estimated Expiration: ⤷  Sign Up

Serbia

Patent: 672
Estimated Expiration: ⤷  Sign Up

Singapore

Patent: 201505680R
Estimated Expiration: ⤷  Sign Up

Slovenia

Patent: 58916
Estimated Expiration: ⤷  Sign Up

Patent: 02565
Estimated Expiration: ⤷  Sign Up

Patent: 31475
Estimated Expiration: ⤷  Sign Up

South Africa

Patent: 1707780
Estimated Expiration: ⤷  Sign Up

South Korea

Patent: 1858913
Estimated Expiration: ⤷  Sign Up

Patent: 2068423
Estimated Expiration: ⤷  Sign Up

Patent: 2369405
Estimated Expiration: ⤷  Sign Up

Patent: 150107872
Estimated Expiration: ⤷  Sign Up

Patent: 170094012
Estimated Expiration: ⤷  Sign Up

Patent: 180015232
Estimated Expiration: ⤷  Sign Up

Patent: 200006633
Estimated Expiration: ⤷  Sign Up

Spain

Patent: 94787
Estimated Expiration: ⤷  Sign Up

Patent: 64459
Estimated Expiration: ⤷  Sign Up

Patent: 69277
Estimated Expiration: ⤷  Sign Up

Taiwan

Patent: 33103
Estimated Expiration: ⤷  Sign Up

Patent: 35863
Estimated Expiration: ⤷  Sign Up

Patent: 70269
Estimated Expiration: ⤷  Sign Up

Patent: 63881
Estimated Expiration: ⤷  Sign Up

Patent: 1444834
Estimated Expiration: ⤷  Sign Up

Patent: 1711687
Estimated Expiration: ⤷  Sign Up

Patent: 1803872
Estimated Expiration: ⤷  Sign Up

Patent: 1906611
Estimated Expiration: ⤷  Sign Up

Turkey

Patent: 1816077
Estimated Expiration: ⤷  Sign Up

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
Netherlands 300863 ⤷  Sign Up
Canada 2900322 FORMES SOLIDES D'UN INHIBITEUR SELECTIF DE CDK4/6 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR) ⤷  Sign Up
Australia 2016272881 Solid dosage forms of palbociclib ⤷  Sign Up
Portugal 2958916 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for IBRANCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 SPC/GB17/026 United Kingdom ⤷  Sign Up 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
1470124 614 Finland ⤷  Sign Up
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.