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Last Updated: March 18, 2024

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 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 six tentative approvals for this compound.

Summary for palbociclib
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for palbociclib
Generic Entry Dates for palbociclib*:
Constraining patent/regulatory exclusivity:
Dosage:
CAPSULE;ORAL
Generic Entry Dates for palbociclib*:
Constraining patent/regulatory exclusivity:
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 palbociclib

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

SponsorPhase
University of MiamiPhase 2
Korea University Guro HospitalPhase 2
Peking Union Medical College HospitalPhase 3

See all palbociclib clinical trials

Generic filers with tentative approvals for PALBOCICLIB
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial125MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial100MGCAPSULE;ORAL
⤷  Try a Trial⤷  Try a Trial125MGCAPSULE;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 ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-001 Nov 1, 2019 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-002 Feb 3, 2015 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
>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 207103-002 Feb 3, 2015 ⤷  Try a Trial ⤷  Try a Trial
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-001 Feb 3, 2015 ⤷  Try a Trial ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-001 Nov 1, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-001 Nov 1, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer IBRANCE palbociclib TABLET;ORAL 212436-003 Nov 1, 2019 ⤷  Try a Trial ⤷  Try a Trial
Pfizer IBRANCE palbociclib CAPSULE;ORAL 207103-003 Feb 3, 2015 ⤷  Try a Trial ⤷  Try a Trial
>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
South Korea 20040077759 ⤷  Try a Trial
Norway 2017014 ⤷  Try a Trial
Hungary S1700019 ⤷  Try a Trial
European Patent Office 3431475 FORMES SOLIDES D'UN INHIBITEUR SÉLECTIF DE CDK4/6 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR) ⤷  Try a Trial
Hong Kong 1162026 ⤷  Try a Trial
Australia 2003237009 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for palbociclib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1470124 614 Finland ⤷  Try a Trial
1470124 CR 2017 00010 Denmark ⤷  Try a Trial 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 PA2017013,C1470124 Lithuania ⤷  Try a Trial PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109
1470124 C20170012 00212 Estonia ⤷  Try a Trial PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016
1470124 132017000046148 Italy ⤷  Try a Trial 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 SPC/GB17/026 United Kingdom ⤷  Try a Trial 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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