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Palbociclib - Generic Drug Details
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What are the generic 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 five 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 thirteen patent family members in fifty-four countries.
There are thirteen drug master file entries for palbociclib. Three suppliers are listed for this compound.
Summary for palbociclib
| International Patents: | 113 |
| US Patents: | 5 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 3 |
| Raw Ingredient (Bulk) Api Vendors: | 93 |
| Clinical Trials: | 212 |
| Patent Applications: | 3,532 |
| 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 |
|---|---|
| EnhancedBio USA Inc. | Phase 1/Phase 2 |
| Sun Yat-sen University | Phase 2 |
| Zenopharm LLC | Phase 1/Phase 2 |
Pharmacology for palbociclib
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Kinase Inhibitors Cytochrome P450 3A Inhibitors |
Paragraph IV (Patent) Challenges for PALBOCICLIB
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| IBRANCE | TABLET;ORAL | palbociclib | 212436 | 2020-11-24 |
| IBRANCE | CAPSULE;ORAL | palbociclib | 207103 | 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 | 212436-003 | Nov 1, 2019 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Y | Get Started for $10 | ||
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-002 | Nov 1, 2019 | RX | Yes | No | Get Started for $10 | Get Started for $10 | Y | Y | Get Started for $10 | ||
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-003 | Feb 3, 2015 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Get Started for $10 | ||||
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-003 | Nov 1, 2019 | RX | Yes | Yes | Get Started for $10 | Get Started for $10 | Y | Y | Get Started for $10 | ||
| >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 |
|---|---|---|
| Serbia | 51044 | Get Started for $10 |
| Portugal | 2958916 | Get Started for $10 |
| Brazil | PI0307057 | Get Started for $10 |
| Singapore | 11201505680R | Get Started for $10 |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for palbociclib
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1470124 | 1790011-9 | Sweden | Get Started for $10 | PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/16/1147 20161111 |
| 1470124 | PA2017013,C1470124 | Lithuania | Get Started for $10 | PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109 |
| 1470124 | CA 2017 00010 | Denmark | Get Started for $10 | 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 | 333 9-2017 | Slovakia | Get Started for $10 | PRODUCT NAME: PALBOCIKLIB; REGISTRATION NO/DATE: EU/1/16/1147 20161111 |
| >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 verification 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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