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Last Updated: July 6, 2020

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IBRANCE Drug 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 Inc and is included in two NDAs. There are four patents protecting this drug and one Paragraph IV challenge.

This drug has seventy-two patent family members in forty-nine 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.

US ANDA Litigation and 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 January 16, 2023. This may change due to patent challenges or generic licensing.

There have been two 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

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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
Royal Marsden NHS Foundation TrustPhase 1
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2
Breast Cancer NowPhase 1

See all IBRANCE clinical trials

Pharmacology for IBRANCE
Paragraph IV (Patent) Challenges for IBRANCE
Tradename Dosage Ingredient NDA Submissiondate
IBRANCE CAPSULE;ORAL palbociclib 207103 2019-02-04

US Patents and Regulatory Information for IBRANCE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer Inc IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pfizer Inc IBRANCE palbociclib CAPSULE;ORAL 207103-001 Feb 3, 2015 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for IBRANCE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1470124 C01470124/01 Switzerland   Start Trial PRODUCT NAME: PALBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66138 31.01.2017
1470124 C20170012 00212 Estonia   Start Trial PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124 LUC00009 Luxembourg   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Harvard Business School
Colorcon
Mallinckrodt
McKinsey
Medtronic

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.