IBRANCE Drug Patent Profile
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When do Ibrance patents expire, and what generic alternatives are available?
Ibrance is a drug marketed by Pfizer and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and sixty-six patent family members in fifty-six countries.
The generic ingredient in IBRANCE is palbociclib. There are thirteen drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the palbociclib profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Ibrance
A generic version of IBRANCE was approved as palbociclib by SYNTHON PHARMS INC on June 5th, 2024.
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Summary for IBRANCE
| International Patents: | 166 |
| US Patents: | 3 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 113 |
| Clinical Trials: | 127 |
| Patent Applications: | 1,620 |
| Drug Prices: | Drug price information for IBRANCE |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for IBRANCE |
| What excipients (inactive ingredients) are in IBRANCE? | IBRANCE excipients list |
| DailyMed Link: | IBRANCE at DailyMed |
Recent Clinical Trials for IBRANCE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University Medical Center Groningen | Phase 4 |
| AstraZeneca | Phase 1/Phase 2 |
| Relay Therapeutics, Inc. | Phase 1 |
Pharmacology for IBRANCE
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Paragraph IV (Patent) Challenges for IBRANCE
| 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 IBRANCE
IBRANCE is protected by three US patents.
Patents protecting IBRANCE
Solid forms of a selective CDK4/6 inhibitor
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid dosage forms of palbociclib
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
| 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 | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-001 | Nov 1, 2019 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-002 | Nov 1, 2019 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | ||
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-001 | Nov 1, 2019 | AB | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | 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 IBRANCE
| 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 | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | ⤷ 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 |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for IBRANCE
| 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 IBRANCE
When does loss-of-exclusivity occur for IBRANCE?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 4842
Patent: FORMAS SÓLIDAS DE UN INHIBIDOR CDK4/6 SELECTIVO
Estimated Expiration: ⤷ Sign Up
Patent: 4909
Patent: FORMAS DE DOSIFICACIÓN SÓLIDAS DE PALBOCICLIB
Estimated Expiration: ⤷ Sign Up
Australia
Patent: 14220354
Patent: Solid forms of a selective CDK4/6 inhibitor
Estimated Expiration: ⤷ Sign Up
Patent: 16272881
Patent: Solid dosage forms of palbociclib
Estimated Expiration: ⤷ Sign Up
Patent: 19204689
Patent: Solid dosage forms of palbociclib
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 2015019508
Patent: formas sólidas de um inibidor de cdk4/6 seletivo
Estimated Expiration: ⤷ Sign Up
Patent: 2017025398
Patent: formas de dosagem sólidas de palbociclib
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 00322
Patent: FORMES SOLIDES D'UN INHIBITEUR SELECTIF DE CDK4/6 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 31892
Patent: FORMES DE DOSAGE SOLIDES DE PALBOCICLIB (SOLID DOSAGE FORMS OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 17003089
Patent: Formas de dosificación sólidas de palbociclib
Estimated Expiration: ⤷ Sign Up
China
Patent: 5008357
Patent: Solid forms of a selective CDK4/6 inhibitor
Estimated Expiration: ⤷ Sign Up
Patent: 7666914
Patent: 帕博西尼的固体剂型 (SOLID DOSAGE FORMS OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Patent: 7759594
Patent: 选择性CDK4/6抑制剂的固态形式 (Solid forms of a selective CDK4/6 inhibitor)
Estimated Expiration: ⤷ Sign Up
Patent: 1253394
Patent: 选择性CDK4/6抑制剂的固态形式 (Solid forms of a selective CDK4/6 inhibitor)
Estimated Expiration: ⤷ Sign Up
Patent: 3616606
Patent: 帕博西尼的固体剂型 (Solid dosage forms of palbociclib)
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 17012362
Patent: Formas de dosificación sólida que comprenden palbociclib, un ácido hidrosoluble y un portador farmacéuticamente aceptable y métodos para su produccion y uso
Estimated Expiration: ⤷ Sign Up
Costa Rica
Patent: 170540
Patent: FORMAS DE DOSIFICACIÓN SOLIDAS DE PALBOCICLIB
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0192065
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 20734
Estimated Expiration: ⤷ Sign Up
Patent: 22454
Estimated Expiration: ⤷ Sign Up
Patent: 24068
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 58916
Estimated Expiration: ⤷ Sign Up
Patent: 02565
Estimated Expiration: ⤷ Sign Up
Patent: 31475
Estimated Expiration: ⤷ Sign Up
Dominican Republic
Patent: 017000280
Patent: FORMAS ADMINISTRACIÓN SÓLIDAS DE PALBOCICLIB
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 17085737
Patent: FORMAS DE DOSIFICACIÓN SÓLIDAS DE PALBOCICLIB
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 58916
Patent: FORMES SOLIDES D'UN INHIBITEUR SÉLECTIF DE CDK4/6 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 02565
Patent: FORMES GALÉNIQUES SOLIDES DE PALBOCICLIB (SOLID DOSAGE FORMS OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Patent: 31475
Patent: FORMES SOLIDES D'UN INHIBITEUR SÉLECTIF DE CDK4/6 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 36283
Patent: FORMES GALÉNIQUES SOLIDES DE PALBOCICLIB (SOLID DOSAGE FORMS OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 11032
Patent: 選擇性 抑制劑的固態形式 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR CDK4/6)
Estimated Expiration: ⤷ Sign Up
Patent: 48217
Patent: 選擇性CDK4/6抑制劑的固態形式 (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 50570
Patent: 帕博西尼的固體劑型 (SOLID DOSAGE FORMS OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 40434
Estimated Expiration: ⤷ Sign Up
Patent: 47477
Estimated Expiration: ⤷ Sign Up
Patent: 54212
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 0277
Patent: צורות מוצקות של מעכב סלקטיבי של cdk4/6 (Solid forms of a selective cdk4/6 inhibitor)
Estimated Expiration: ⤷ Sign Up
Patent: 5632
Patent: צורות מתן מוצקות של פלבוציקליב (Solid dosage forms of palbociclib)
Estimated Expiration: ⤷ Sign Up
Patent: 7437
Patent: צורות מתן מוצקות של פלבוציקליב (Solid dosage forms of palbociclib)
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 81016
Estimated Expiration: ⤷ Sign Up
Patent: 24152
Estimated Expiration: ⤷ Sign Up
Patent: 14162794
Patent: SOLID FORM OF SELECTIVE CDK 4/6 INHIBITOR
Estimated Expiration: ⤷ Sign Up
Patent: 17002034
Patent: パルボシクリブの固形剤形 (SOLID DOSAGE FORM OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Patent: 17186376
Patent: 選択的ＣＤＫ４／６阻害剤の固体形態 (SOLID FORM OF SELECTIVE CDK4/6 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 19116512
Patent: 選択的ＣＤＫ４／６阻害剤の固体形態 (SOLID FORM OF SELECTIVE CDK4/6 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 21167343
Patent: パルボシクリブの固形剤形 (SOLID DOSAGE FORM OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Patent: 23112149
Patent: パルボシクリブの固形剤形 (SOLID DOSAGE FORM OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Lithuania
Patent: 02565
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 3715
Patent: FORMAS SOLIDAS DE UN INHBIDOR DE CDK4/6 SELECTIVO. (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR.)
Estimated Expiration: ⤷ Sign Up
Patent: 15010858
Patent: FORMAS SOLIDAS DE UN INHBIDOR DE CDK4/6 SELECTIVO. (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR.)
Estimated Expiration: ⤷ Sign Up
Patent: 17015579
Patent: FORMAS DE DOSIFICACION SOLIDAS DE PALBOCICLIB. (SOLID DOSAGE FORMS OF PALBOCICLIB.)
Estimated Expiration: ⤷ Sign Up
Patent: 19003605
Patent: FORMAS SOLIDAS DE UN INHIBIDOR DE CDK4/6 SELECTIVO. (SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR.)
Estimated Expiration: ⤷ Sign Up
Patent: 20003825
Patent: FORMAS DE DOSIFICACION SOLIDAS DE PALBOCICLIB. (SOLID DOSAGE FORMS OF PALBOCICLIB.)
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 0138
Patent: Solid forms of a selective cdk4/6 inhibitor
Estimated Expiration: ⤷ Sign Up
Patent: 7391
Patent: Solid dosage forms of palbociclib
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 180395
Patent: FORMAS DE DOSIFICACION SOLIDAS DE PALBOCICLIB
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 58916
Estimated Expiration: ⤷ Sign Up
Patent: 02565
Estimated Expiration: ⤷ Sign Up
Patent: 31475
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 58916
Estimated Expiration: ⤷ Sign Up
Patent: 02565
Estimated Expiration: ⤷ Sign Up
Patent: 31475
Estimated Expiration: ⤷ Sign Up
Russian Federation
Patent: 19944
Patent: Твердые формы селективного ингибитора CDK4/6 (SOLID FORMS OF SELECTIVE CDK4/6 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 86840
Patent: Твёрдые лекарственные формы палбоциклиба (SOLID DOSAGE FORMS OF PALLBOCYCLOB)
Estimated Expiration: ⤷ Sign Up
Patent: 15132371
Patent: Твердые формы селективного ингибитора CDK4/6
Estimated Expiration: ⤷ Sign Up
Saudi Arabia
Patent: 7390473
Patent: أشكال جرعة صلبة من بالبوسيكليب (SOLID DOSAGE FORMS OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 672
Patent: ČVRSTI DOZNI OBLICI PALBOCIKLIBA (SOLID DOSAGE FORMS OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Singapore
Patent: 201505680R
Patent: SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 58916
Estimated Expiration: ⤷ Sign Up
Patent: 02565
Estimated Expiration: ⤷ Sign Up
Patent: 31475
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1707780
Patent: SOLID DOSAGE FORMS OF PALBOCICLIB
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1858913
Estimated Expiration: ⤷ Sign Up
Patent: 2068423
Estimated Expiration: ⤷ Sign Up
Patent: 2369405
Estimated Expiration: ⤷ Sign Up
Patent: 150107872
Patent: SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR
Estimated Expiration: ⤷ Sign Up
Patent: 170094012
Patent: 고체 형태의 선택적인 CDK4/6 억제제 (CDK4/6 SOLID FORMS OF A SELECTIVE CDK4/6 INHIBITOR)
Estimated Expiration: ⤷ Sign Up
Patent: 180015232
Patent: 팔보시클립의 고체 투여 형태
Estimated Expiration: ⤷ Sign Up
Patent: 200006633
Patent: 팔보시클립의 고체 투여 형태 (SOLID DOSAGE FORMS OF PALBOCICLIB)
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 94787
Estimated Expiration: ⤷ Sign Up
Patent: 64459
Estimated Expiration: ⤷ Sign Up
Patent: 69277
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 33103
Estimated Expiration: ⤷ Sign Up
Patent: 35863
Estimated Expiration: ⤷ Sign Up
Patent: 70269
Estimated Expiration: ⤷ Sign Up
Patent: 63881
Estimated Expiration: ⤷ Sign Up
Patent: 1444834
Patent: Solid forms of a selective CDK4/6 inhibitor
Estimated Expiration: ⤷ Sign Up
Patent: 1711687
Patent: Solid dosage forms of palbociclib
Estimated Expiration: ⤷ Sign Up
Patent: 1803872
Patent: Solid forms of a selective CDK4/6 inhibitor
Estimated Expiration: ⤷ Sign Up
Patent: 1906611
Patent: Solid dosage forms of palbociclib
Estimated Expiration: ⤷ Sign Up
Turkey
Patent: 1816077
Estimated Expiration: ⤷ Sign Up
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering IBRANCE around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Argentina | 038814 | COMPUESTOS DE 2-(PIRIDIN-2-ILAMINO)-PIRIDO[2,3-D]PIRIMIDIN-7-ONA Y USO EN LA FABRICACION DE MEDICAMENTOS | ⤷ Sign Up |
| European Patent Office | 3636283 | FORMES GALÉNIQUES SOLIDES DE PALBOCICLIB (SOLID DOSAGE FORMS OF PALBOCICLIB) | ⤷ Sign Up |
| Australia | 2016272881 | Solid dosage forms of palbociclib | ⤷ Sign Up |
| Hungary | S1700019 | ⤷ Sign Up | |
| Japan | 2017186376 | 選択的ＣＤＫ４／６阻害剤の固体形態 (SOLID FORM OF SELECTIVE CDK4/6 INHIBITOR) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IBRANCE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1470124 | LUC00009 | Luxembourg | ⤷ Sign Up | 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 | 614 | Finland | ⤷ Sign Up | |
| 1470124 | PA2017013 | Lithuania | ⤷ Sign Up | PRODUCT NAME: PALBOCIKLIBAS, PASIRINKTINAI FARMACINIU POZIURIU PRIIMTINOS DRUSKOS, ESTERIO, AMIDO ARBA PROVAISTO PAVIDALU; REGISTRATION NO/DATE: EU/1/16/1147 20161109 |
| 1470124 | 17C1012 | France | ⤷ Sign Up | 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 | ⤷ Sign Up | 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 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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