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
| International Patents: | 166 |
| US Patents: | 3 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 2 |
| Drug Master File Entries: | 13 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 114 |
| Clinical Trials: | 285 |
| Patent Applications: | 3,386 |
| 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 |
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
| Sponsor | Phase |
|---|---|
| University of Miami | Phase 2 |
| Korea University Guro Hospital | Phase 2 |
| Jiangsu HengRui Medicine Co., Ltd. | Phase 3 |
Generic filers with tentative approvals for PALBOCICLIB
| Applicant | Application No. | Strength | Dosage Form |
| ⤷ Try a Trial | ⤷ Try a Trial | 125MG | CAPSULE;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 100MG | CAPSULE;ORAL |
| ⤷ Try a Trial | ⤷ Try a Trial | 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 | 212436-001 | Nov 1, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | 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 | ||
| >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 | 207103-001 | 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 | CAPSULE;ORAL | 207103-001 | 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 |
|---|---|---|---|
| Uruguay | 27617 | 2 - (PIRIDIN -2 - ILAMINO) - PIRIDO (2,3-D ) PIRIMIDIN -7 ONAS | ⤷ Try a Trial |
| Lithuania | PA2017013 | ⤷ Try a Trial | |
| China | 105008357 | Solid forms of a selective CDK4/6 inhibitor | ⤷ 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 | 1790011-9 | Sweden | ⤷ Try a Trial | PRODUCT NAME: PALBOCICLIB, OPTIONALLY IN THE FORM OF A PHARMACEUTICALLY ACCEPTABLE SALT; REG. NO/DATE: EU/1/16/1147 20161111 |
| 1470124 | 300863 | Netherlands | ⤷ Try a Trial | PRODUCT NAME: PALBOCICLIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/16/1147 20161111 |
| 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 |
| >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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