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Palbociclibis 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 fifty-one patent family members in fifty-five countries.
There are thirteen drug master file entries for palbociclib. Three suppliers are listed for this compound. There are two tentative approvals for this compound.
Summary for palbociclib
|Drug Master File Entries:||13|
|Finished Product Suppliers / Packagers:||3|
|Raw Ingredient (Bulk) Api Vendors:||101|
|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
|Washington University School of Medicine||Phase 3|
|Gustave Roussy, Cancer Campus, Grand Paris||Phase 2|
|Ascentage Pharma Group Inc.||Phase 1/Phase 2|
Generic filers with tentative approvals for PALBOCICLIB
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||Kinase Inhibitors |
Cytochrome P450 3A Inhibitors
|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||212436-001||Nov 1, 2019||RX||Yes||No||⤷ Try it Free||⤷ Try it Free||Y||Y||⤷ Try it Free|
|Pfizer||IBRANCE||palbociclib||TABLET;ORAL||212436-002||Nov 1, 2019||RX||Yes||No||⤷ Try it Free||⤷ Try it Free||Y||Y||⤷ Try it Free|
|Pfizer||IBRANCE||palbociclib||CAPSULE;ORAL||207103-002||Feb 3, 2015||RX||Yes||No||⤷ Try it Free||⤷ Try it Free||⤷ Try it Free|
|>Applicant||>Tradename||>Generic Name||>Dosage||>NDA||>Approval Date||>TE||>Type||>RLD||>RS||>Patent No.||>Patent Expiration||>Product||>Substance||>Delist Req.||>Exclusivity Expiration|
|Patent Number||Supplementary Protection Certificate||SPC Country||SPC Expiration||SPC Description|
|1470124||LUC00009||Luxembourg||⤷ Try it Free||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|
|1470124||PA2017013||Lithuania||⤷ Try it Free||PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ESTERIO, AMIDO ARBA PROVAISTO PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109|
|1470124||CR 2017 00010||Denmark||⤷ Try it Free||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|
|>Patent Number||>Supplementary Protection Certificate||>SPC Country||>SPC Expiration||>SPC Description|
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