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Palbociclib - Generic Drug Details
What are the generic drug sources for palbociclib and what is the scope of patent protection?
Palbociclib
is the generic ingredient in one branded drug marketed by Pfizer Inc and is included in one NDA. 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 seventy-two patent family members in forty-nine countries.
There are thirteen drug master file entries for palbociclib. Two suppliers are listed for this compound.
Summary for palbociclib
| International Patents: | 72 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Drug Master File Entries: | 13 |
| Suppliers / Packagers: | 2 |
| Bulk Api Vendors: | 84 |
| Clinical Trials: | 175 |
| Patent Applications: | 248 |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for palbociclib |
| DailyMed Link: | palbociclib at DailyMed |
Recent Clinical Trials for palbociclib
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Hoffmann-La Roche | Phase 3 |
| Shengjing Hospital | Phase 3 |
| Abramson Cancer Center of the University of Pennsylvania | Phase 1 |
Recent Litigation for palbociclib
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Pfizer Inc. v. Mylan Pharmaceuticals Inc. | 2019-04-25 |
Pharmacology for palbociclib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors Cytochrome P450 3A Inhibitors |
Synonyms for palbociclib
| 190P302 |
| 2euf |
| 2euf; PD 0332991 |
| 571190-30-2 |
| 571190-30-2 pound not827022-32-2 |
| 6-acetyl-8-cyclopentyl-5-methyl-2-((5-(piperazin-1-yl)pyridin-2-yl)amino)pyrido[2,3-d]pyrimidin-7(8H)-one |
| 6-Acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-8H-pyrido[2,3-d]pyrimidin-7-one |
| 6-acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-yl-pyridin-2-ylamino)-8h-pyrido[2,3-d]pyrimidin-7-one hydrochloride |
| 6-Acetyl-8-cyclopentyl-5-methyl-2-(5-piperazin-1-ylpyridin-2-ylamino)-8H-pyrido(2,3-d)pyrimidin-7-one |
| 6-acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-yl-2-pyridyl)amino]pyrido[2,3-d]pyrimidin-7-one |
| 6-acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino] pyrido[2,3-d]pyrimidin-7-one |
| 6-acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrido[2,3-d]pyrimidin-7-one |
| 6-ACETYL-8-CYCLOPENTYL-5-METHYL-2-[(5-PIPERAZIN-1-YLPYRIDIN-2-YL)AMINO]PYRIDO[2,3-D]PYRIMIDIN-7(8H)-ONE |
| 6-acetyl-8-cyclopentyl-5-methyl-2-[(5-piperazin-1-ylpyridin-2-yl)amino]pyrido[6,5-d]pyrimidin-7-one |
| 6-Acetyl-8-cyclopentyl-5-methyl-2-[[5-(piperazin-1-yl)pyridin-2-yl]amino]-8H-pyrido[2,3-d]pyrimidin-7-one |
| 6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H,8H-pyrido[2,3-d]pyrimidin-7-one |
| 6-acetyl-8-cyclopentyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}pyrido[2,3-d]pyrimidin-7(8H)-one |
| 8-cyclopentyl-6-acetyl-5-methyl-2-{[5-(piperazin-1-yl)pyridin-2-yl]amino}-7H,8H-pyrido[2,3-d]pyrimidin-7-one |
| A1-04309 |
| ABP000842 |
| AC-25485 |
| AC1NS8RV |
| AHJRHEGDXFFMBM-UHFFFAOYSA-N |
| AK173631 |
| AKOS022205241 |
| AN-16841 |
| AOB87334 |
| AS-17016 |
| AX8167187 |
| BC654107 |
| BCP09274 |
| BCP9001058 |
| BCPP000125 |
| BDBM6309 |
| BRD-K51313569-001-01-1 |
| C24H29N7O2 |
| CA10003 |
| CHEBI:85993 |
| CHEMBL189963 |
| D10372 |
| DB09073 |
| EBD24067 |
| EX-A408 |
| FT-0697059 |
| G9ZF61LE7G |
| GTPL7380 |
| HMS3265M09 |
| HMS3265M10 |
| HMS3265N09 |
| HMS3265N10 |
| HY-50767 |
| Ibrance |
| Ibrance (TN) |
| KB-79781 |
| KIN0000560 |
| Kinome_3823 |
| Kinome_3824 |
| LQQ |
| MFCD11840850 |
| MolPort-009-679-393 |
| NCGC00263129-01 |
| NCGC00263129-21 |
| OTAVA-BB 1115529 |
| P-0332991 |
| Palbociclib (JAN/USAN) |
| Palbociclib [USAN:INN] |
| Palbociclib free base |
| Palbociclib(PD0332991) |
| PD 0332991 |
| PD 0332991,PD0332991 |
| PD 332991 |
| PD 332991, PD 0332991, 827022-32-2 |
| PD-033299 |
| PD-0332991 |
| PD-0332991, PD0332991 |
| PD-0332991/PD0332991,PD332991 |
| PD-332991 |
| PD0332991 |
| PubChem16671 |
| Pyrido-[2,3-d]-pyrimidin-7-one 43 |
| Pyrido(2,3-d)pyrimidin-7(8H)-one, 6-acetyl-8-cyclopentyl-5-methyl-2-((5-(1-piperazinyl)-2-pyridinyl)amino)- |
| QCR-200 |
| S14-2748 |
| SC-92588 |
| SCHEMBL462630 |
| UNII-G9ZF61LE7G |
| X7379 |
| Z-3143 |
| ZINC3938686 |
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 Inc | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-003 | Feb 3, 2015 | RX | Yes | Yes | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Pfizer Inc | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| Pfizer Inc | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | RX | Yes | No | Start Trial | Start Trial | Y | Y | Start Trial | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for palbociclib
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Lithuania | C1470124 | Start Trial |
| Israel | 162721 | Start Trial |
| Montenegro | 00230 | Start Trial |
| Poland | 391191 | Start Trial |
| China | 101906104 | Start Trial |
| Brazil | PI0307057 | Start Trial |
| Serbia | 59804 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for palbociclib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1470124 | C 2017 016 | Romania | Start Trial | 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 | LUC00009 | Luxembourg | Start Trial | 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 | 2017/009 | Ireland | Start Trial | 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 | 300863 | Netherlands | Start Trial | PRODUCT NAME: PALBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1147 20161111 |
| 1470124 | C20170012 00212 | Estonia | Start Trial | PRODUCT NAME: PALBOTSIKLIIB;REG NO/DATE: EU/1/16/1147 11.11.2016 |
| 1470124 | 17C1012 | France | Start Trial | PRODUCT NAME: PALBOCICLIB, ET TOUTES SES FORMES RELEVANT DE LA PROTECTION DU BREVET DE BASE.; REGISTRATION NO/DATE: EU/1/16/1147 20161109 |
| 1470124 | C01470124/01 | Switzerland | Start Trial | PRODUCT NAME: PALBOCICLIB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66138 31.01.2017 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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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 verifification 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.
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Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
ISSN: 2162-2639
Privacy and Cookies
Terms & Conditions
Site Map
DrugPatentWatch Alternatives
Major Patent Expirations 2019 - 2020
NCE-1 Generic Application Dates 2019 - 2020
Preferred Citation:
Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2019, www.DrugPatentWatch.com.