IBRANCE Drug Patent Profile
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When do Ibrance patents expire, and when can generic versions of Ibrance launch?
Ibrance is a drug marketed by Pfizer and is included in two NDAs. There are six patents protecting this drug and two Paragraph IV challenges.
This drug has one hundred and sixty-three 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® Generic Entry Outlook for Ibrance
Ibrance was eligible for patent challenges on February 3, 2019.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be February 8, 2034. This may change due to patent challenges or generic licensing.
There have been seventeen patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
There are five tentative approvals for the generic drug (palbociclib), which indicates the potential for near-term generic launch.
Indicators of Generic Entry
Summary for IBRANCE
| International Patents: | 163 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 2 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 111 |
| Clinical Trials: | 123 |
| Patent Applications: | 2,700 |
| 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 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for IBRANCE
Generic Entry Dates for IBRANCE*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
CAPSULE;ORAL |
Generic Entry Dates for IBRANCE*:
Constraining patent/regulatory exclusivity:
NDA:
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 IBRANCE
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Relay Therapeutics, Inc. | Phase 1 |
| University of Michigan Rogel Cancer Center | Phase 4 |
| Stemline Therapeutics, Inc. | Phase 1/Phase 2 |
Pharmacology for IBRANCE
| Drug Class | Kinase Inhibitor |
| Mechanism of Action | Cytochrome P450 3A Inhibitors Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for IBRANCE
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 eight US patents.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of IBRANCE is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting IBRANCE
Solid forms of a selective CDK4/6 inhibitor
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid dosage forms of palbociclib
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2-(Pyridin-2-ylamino)-pyrido[2,3-d]pyrimidin-7-ones
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2-(pyridin-2-ylamino)-pyrido [2,3-d]pyrimidin-7-ones
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: TREATING HR-POS., HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER WITH PALBOCICLIB IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE BASED THERAPY IN POSTMENOPAUSAL WOMEN OR FULVESTRANT IN WOMEN WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR AS INITIAL ENDOCRINE-BASED THERAPY IN POSTMENOPAUSAL WOMEN OR MEN, OR WITH FULVESTRANT IN PTS WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
2-(pyridin-2-ylamino)-pyrido[2,3, d]pyrimidin-7-ones
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: PALBOCICLIB FOR HR-POS. HER2-NEG. ADVANCED OR METASTATIC BREAST CANCER IN COMBO WITH AN AROMATASE INHIBITOR IN PTS AS INITIAL ENDOCRINE-BASED THERAPY OR WITH FULVESTRANT WITH DISEASE PROGRESSION AFTER ENDOCRINE THERAPY
2-(pyridin-2-ylamino)-pyrido[2,3-D]pyrimidin-7-ones
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-002 | Nov 1, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-002 | Nov 1, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-002 | Nov 1, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | ||||
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-003 | Feb 3, 2015 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | Y | ⤷ Try a Trial | ||
| Pfizer | IBRANCE | palbociclib | TABLET;ORAL | 212436-001 | Nov 1, 2019 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | 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 IBRANCE
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-002 | Feb 3, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-001 | Feb 3, 2015 | ⤷ Try a Trial | ⤷ Try a Trial |
| 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 | TABLET;ORAL | 212436-002 | Nov 1, 2019 | ⤷ Try a Trial | ⤷ Try a Trial |
| Pfizer | IBRANCE | palbociclib | CAPSULE;ORAL | 207103-003 | 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 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
Estimated Expiration: ⤷ Try a Trial
Patent: 4909
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 14220354
Estimated Expiration: ⤷ Try a Trial
Patent: 16272881
Estimated Expiration: ⤷ Try a Trial
Patent: 19204689
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 2015019508
Estimated Expiration: ⤷ Try a Trial
Patent: 2017025398
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 00322
Estimated Expiration: ⤷ Try a Trial
Patent: 31892
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 17003089
Estimated Expiration: ⤷ Try a Trial
China
Patent: 5008357
Estimated Expiration: ⤷ Try a Trial
Patent: 7666914
Estimated Expiration: ⤷ Try a Trial
Patent: 7759594
Estimated Expiration: ⤷ Try a Trial
Patent: 1253394
Estimated Expiration: ⤷ Try a Trial
Patent: 3616606
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 17012362
Estimated Expiration: ⤷ Try a Trial
Costa Rica
Patent: 170540
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0192065
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 20734
Estimated Expiration: ⤷ Try a Trial
Patent: 22454
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 58916
Estimated Expiration: ⤷ Try a Trial
Patent: 02565
Estimated Expiration: ⤷ Try a Trial
Patent: 31475
Estimated Expiration: ⤷ Try a Trial
Dominican Republic
Patent: 017000280
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 17085737
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 58916
Estimated Expiration: ⤷ Try a Trial
Patent: 02565
Estimated Expiration: ⤷ Try a Trial
Patent: 31475
Estimated Expiration: ⤷ Try a Trial
Patent: 36283
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 11032
Estimated Expiration: ⤷ Try a Trial
Patent: 48217
Estimated Expiration: ⤷ Try a Trial
Patent: 50570
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 40434
Estimated Expiration: ⤷ Try a Trial
Patent: 47477
Estimated Expiration: ⤷ Try a Trial
Patent: 54212
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 0277
Estimated Expiration: ⤷ Try a Trial
Patent: 5632
Estimated Expiration: ⤷ Try a Trial
Patent: 7437
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 81016
Estimated Expiration: ⤷ Try a Trial
Patent: 24152
Estimated Expiration: ⤷ Try a Trial
Patent: 14162794
Estimated Expiration: ⤷ Try a Trial
Patent: 17002034
Estimated Expiration: ⤷ Try a Trial
Patent: 17186376
Estimated Expiration: ⤷ Try a Trial
Patent: 19116512
Estimated Expiration: ⤷ Try a Trial
Patent: 21167343
Estimated Expiration: ⤷ Try a Trial
Lithuania
Patent: 02565
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 3715
Estimated Expiration: ⤷ Try a Trial
Patent: 15010858
Estimated Expiration: ⤷ Try a Trial
Patent: 17015579
Estimated Expiration: ⤷ Try a Trial
Patent: 19003605
Estimated Expiration: ⤷ Try a Trial
Patent: 20003825
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 0138
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 180395
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 58916
Estimated Expiration: ⤷ Try a Trial
Patent: 02565
Estimated Expiration: ⤷ Try a Trial
Patent: 31475
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 58916
Estimated Expiration: ⤷ Try a Trial
Patent: 02565
Estimated Expiration: ⤷ Try a Trial
Patent: 31475
Estimated Expiration: ⤷ Try a Trial
Russian Federation
Patent: 19944
Estimated Expiration: ⤷ Try a Trial
Patent: 86840
Estimated Expiration: ⤷ Try a Trial
Patent: 15132371
Estimated Expiration: ⤷ Try a Trial
Saudi Arabia
Patent: 7390473
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 672
Estimated Expiration: ⤷ Try a Trial
Singapore
Patent: 201505680R
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 58916
Estimated Expiration: ⤷ Try a Trial
Patent: 02565
Estimated Expiration: ⤷ Try a Trial
Patent: 31475
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1707780
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1858913
Estimated Expiration: ⤷ Try a Trial
Patent: 2068423
Estimated Expiration: ⤷ Try a Trial
Patent: 2369405
Estimated Expiration: ⤷ Try a Trial
Patent: 150107872
Estimated Expiration: ⤷ Try a Trial
Patent: 170094012
Estimated Expiration: ⤷ Try a Trial
Patent: 180015232
Estimated Expiration: ⤷ Try a Trial
Patent: 200006633
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 94787
Estimated Expiration: ⤷ Try a Trial
Patent: 64459
Estimated Expiration: ⤷ Try a Trial
Patent: 69277
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 33103
Estimated Expiration: ⤷ Try a Trial
Patent: 35863
Estimated Expiration: ⤷ Try a Trial
Patent: 70269
Estimated Expiration: ⤷ Try a Trial
Patent: 63881
Estimated Expiration: ⤷ Try a Trial
Patent: 1444834
Estimated Expiration: ⤷ Try a Trial
Patent: 1711687
Estimated Expiration: ⤷ Try a Trial
Patent: 1803872
Estimated Expiration: ⤷ Try a Trial
Patent: 1906611
Estimated Expiration: ⤷ Try a Trial
Turkey
Patent: 1816077
Estimated Expiration: ⤷ Try a Trial
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 |
|---|---|---|---|
| Georgia, Republic of | P20063909 | 2-(PYRIDIN-2-YLAMINO)-PYRIDO[2,3d] PYRIMIDIN-7-ONES | ⤷ Try a Trial |
| Hungary | E047477 | ⤷ Try a Trial | |
| Taiwan | I635863 | ⤷ Try a Trial | |
| Japan | 4291696 | ⤷ Try a Trial | |
| Australia | 2016272881 | Solid dosage forms of palbociclib | ⤷ Try a Trial |
| Malaysia | 134818 | 2-(PYRIDIN-2-YLAMINO)-PYRIDO[2,3-d]PYRIMIDIN-7-ONES | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for IBRANCE
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1470124 | C 2017 016 | Romania | ⤷ Try a 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 | 333 9-2017 | Slovakia | ⤷ Try a Trial | PRODUCT NAME: PALBOCIKLIB; REGISTRATION NO/DATE: EU/1/16/1147 20161111 |
| 1470124 | 12/2017 | Austria | ⤷ Try a Trial | PRODUCT NAME: PALBOCICLIB, GEGEBENENFALLS IN FORM EINES PHARMAZEUTISCH ANNEHMBAREN SALZES, ESTERS, AMIDS ODER PRODRUGS DAVON; REGISTRATION NO/DATE: EU/1/16/1147/001-006 (MITTEILUNG) 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 |
| 1470124 | 17C1012 | France | ⤷ Try a 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 | 614 | Finland | ⤷ Try a Trial | |
| >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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