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Last Updated: January 27, 2023

Palbociclib - Generic Drug Details


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What are the generic drug sources for palbociclib and what is the scope of freedom to operate?

Palbociclib is the generic ingredient in one branded drug marketed by Pfizer and is included in two NDAs. There are six 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-two patent family members in fifty-five countries.

There are thirteen drug master file entries for palbociclib. Two suppliers are listed for this compound. There are four tentative approvals for this compound.

Summary for palbociclib
Recent Clinical Trials for palbociclib

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

SponsorPhase
Seoul National University HospitalPhase 2
Stemline Therapeutics, Inc.Phase 1/Phase 2
Thomas Jefferson UniversityPhase 1

See all palbociclib clinical trials

Generic filers with tentative approvals for PALBOCICLIB
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing125MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing100MGCAPSULE;ORAL
See Plans and PricingSee Plans and Pricing125MGCAPSULE;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 RX Yes No See Plans and Pricing See Plans and Pricing Y 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 CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No 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
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-001 Feb 3, 2015 RX Yes No See Plans and Pricing See Plans and Pricing Y Y 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
>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 TABLET;ORAL 212436-001 Nov 1, 2019 See Plans and Pricing See Plans and Pricing
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-001 Feb 3, 2015 See Plans and Pricing See Plans and Pricing
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 See Plans and Pricing See Plans and Pricing
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 See Plans and Pricing See Plans and Pricing
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-002 Nov 1, 2019 See Plans and Pricing See Plans and Pricing
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 See Plans and Pricing See Plans and Pricing
>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

International Patents for palbociclib

Country Patent Number Title Estimated Expiration
Taiwan 200302224 See Plans and Pricing
Japan 2019116512 選択的CDK4/6阻害剤の固体形態 (SOLID FORM OF SELECTIVE CDK4/6 INHIBITOR) See Plans and Pricing
Brazil 112017025398 formas de dosagem sólidas de palbociclib See Plans and Pricing
Argentina 038814 COMPUESTOS DE 2-(PIRIDIN-2-ILAMINO)-PIRIDO[2,3-D]PIRIMIDIN-7-ONA Y USO EN LA FABRICACION DE MEDICAMENTOS See Plans and Pricing
Colombia 5700765 2-(PIRIDIN-2-ILAMINO)-PIRIDO[2,3-D] PIRIMIDIN-7-ONAS See Plans and Pricing
Brazil PI0307057 compostos 2-(piridin-2-ilamino)-pirido[2,3-d]pirimidin-7-onas See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for palbociclib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1470124 C 2017 016 Romania See Plans and Pricing PRODUCT NAME: PALBOCICLIB OPTIONAL SUB FORMA DE SARE, ESTER, AMIDA SAUPROMEDICAMENT AL ACESTUIA, ACCEPTABILEFARMACEUTIC; NATIONAL AUTHORISATION NUMBER: EU/1/16/1147; DATE OF NATIONAL AUTHORISATION: 20161109; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1147; DATE OF FIRST AUTHORISATION IN EEA: 20161109
1470124 12/2017 Austria See Plans and Pricing 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 122017000014 Germany See Plans and Pricing 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 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 C20170012 00212 Estonia See Plans and Pricing PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124 SPC/GB17/026 United Kingdom See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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