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 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 five 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: | 296 |
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 Medical Center Groningen | Phase 4 |
Mohammed Milhem | Phase 1 |
AstraZeneca | Phase 1/Phase 2 |
Generic filers with tentative approvals for PALBOCICLIB
Applicant | Application No. | Strength | Dosage Form |
⤷ Sign Up | ⤷ Sign Up | 125MG | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 100MG | CAPSULE;ORAL |
⤷ Sign Up | ⤷ Sign Up | 100MG | 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 |
Anatomical Therapeutic Chemical (ATC) Classes for palbociclib
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 | 212436-003 | Nov 1, 2019 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-003 | Feb 3, 2015 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-002 | Nov 1, 2019 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
>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 | 212436-002 | Nov 1, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-003 | Nov 1, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-001 | Nov 1, 2019 | ⤷ Sign Up | ⤷ Sign Up |
Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-003 | Feb 3, 2015 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Ecuador | SP045201 | 2-(PIRIDIN-2-ILAMINO)-PIRIDO[2,3-d] PIRIMIDIN-7-ONAS | ⤷ Sign Up |
Uruguay | 27617 | 2 - (PIRIDIN -2 - ILAMINO) - PIRIDO (2,3-D ) PIRIMIDIN -7 ONAS | ⤷ Sign Up |
Hungary | E047477 | ⤷ Sign Up | |
Japan | 2023112149 | パルボシクリブの固形剤形 (SOLID DOSAGE FORM OF PALBOCICLIB) | ⤷ Sign Up |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for palbociclib
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1470124 | 132017000046148 | Italy | ⤷ Sign Up | 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 | CA 2017 00010 | Denmark | ⤷ Sign Up | 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 | 122017000014 | Germany | ⤷ Sign Up | 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 | 614 | Finland | ⤷ Sign Up | |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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