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
International Patents: | 162 |
US Patents: | 6 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 2 |
Drug Master File Entries: | 13 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 106 |
Clinical Trials: | 268 |
Patent Applications: | 5,035 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for palbociclib |
What excipients (inactive ingredients) are in palbociclib? | palbociclib excipients list |
DailyMed Link: | palbociclib at DailyMed |
Recent Clinical Trials for palbociclib
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Seoul National University Hospital | Phase 2 |
Stemline Therapeutics, Inc. | Phase 1/Phase 2 |
Thomas Jefferson University | Phase 1 |
Generic filers with tentative approvals for PALBOCICLIB
Applicant | Application No. | Strength | Dosage Form |
See Plans and Pricing | See Plans and Pricing | 125MG | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | 100MG | CAPSULE;ORAL |
See Plans and Pricing | See Plans and Pricing | 125MG | CAPSULE;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
Drug Class | Kinase Inhibitor |
Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
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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