You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: November 21, 2024

Palbociclib - Generic Drug Details


✉ Email this page to a colleague

« Back to Dashboard


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
Recent Clinical Trials for palbociclib

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

SponsorPhase
University Medical Center GroningenPhase 4
Mohammed MilhemPhase 1
AstraZenecaPhase 1/Phase 2

See all palbociclib clinical trials

Generic filers with tentative approvals for PALBOCICLIB
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up125MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up100MGCAPSULE;ORAL
⤷  Sign Up⤷  Sign Up125MGCAPSULE;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
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 TABLET;ORAL 212436-002 Nov 1, 2019 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-001 Nov 1, 2019 AB RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-003 Feb 3, 2015 RX Yes Yes ⤷  Sign Up ⤷  Sign Up Y 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 palbociclib

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

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
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

Supplementary Protection Certificates for palbociclib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1470124 2017/009 Ireland ⤷  Sign Up PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT, ESTER, AMIDE OR PRODRUG THEREOF; REGISTRATION NO/DATE: EU/1/16/1147/001 EU/1/16/1147/006 20161109
1470124 17C1012 France ⤷  Sign Up PRODUCT NAME: PALBOCICLIB, ET TOUTES SES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE.; REGISTRATION NO/DATE: EU/1/16/1147 20161109
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
>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.