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Last Updated: March 29, 2024

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VIZIMPRO Drug Patent Profile


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When do Vizimpro patents expire, and what generic alternatives are available?

Vizimpro is a drug marketed by Pfizer and is included in one NDA. There are four patents protecting this drug.

This drug has ninety-two patent family members in forty-eight countries.

The generic ingredient in VIZIMPRO is dacomitinib. Two suppliers are listed for this compound. Additional details are available on the dacomitinib profile page.

DrugPatentWatch® Generic Entry Outlook for Vizimpro

Vizimpro was eligible for patent challenges on September 27, 2022.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be August 26, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

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Summary for VIZIMPRO
International Patents:92
US Patents:4
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 29
Clinical Trials: 5
Patent Applications: 204
Drug Prices: Drug price information for VIZIMPRO
What excipients (inactive ingredients) are in VIZIMPRO?VIZIMPRO excipients list
DailyMed Link:VIZIMPRO at DailyMed
Drug patent expirations by year for VIZIMPRO
Drug Prices for VIZIMPRO

See drug prices for VIZIMPRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VIZIMPRO
Generic Entry Date for VIZIMPRO*:
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 VIZIMPRO

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Samsung Medical CenterPhase 2
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2
Fondazione Ricerca TraslazionalePhase 2

See all VIZIMPRO clinical trials

US Patents and Regulatory Information for VIZIMPRO

VIZIMPRO is protected by four US patents and two FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIZIMPRO 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 VIZIMPRO

Method for treating gefitinib resistant cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OR ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION WITH T790M MUTATION

Method for treating gefitinib resistant cancer
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: ADMINISTERING DAILY A UNIT DOSAGE OF AN IRREVERSIBLE EGFR INHIBITOR COVALENTLY BINDING AS CLAIMED FOR 1ST LINE TREATMENT OF GEFITINIB OF ERLOTINIB RESISTANT METASTATIC NSCLC WITH EGFR EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION

4-phenylamino-quinazolin-6-yl-amides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

4-phenylamino-quinazolin-6-yl-amides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: FIRST-LINE TREATMENT OF METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC) WITH EGFR EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST

FDA Regulatory Exclusivity protecting VIZIMPRO

FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷  Try a Trial

INDICATED FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WITH EPIDERMAL GROWTH FACTOR (EGFR) EXON 19 DELETION OR EXON 21 L858R SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity 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 VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  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

EU/EMA Drug Approvals for VIZIMPRO

Company Drugname Inn Product Number / Indication Status Generic Biosimilar Orphan Marketing Authorisation Marketing Refusal
Pfizer Europe MA EEIG Vizimpro dacomitinib EMEA/H/C/004779
Vizimpro, as monotherapy, is indicated for the first-line treatment of adult patients with locally advanced or metastatic non small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) activating mutations.
Authorised no no no 2019-04-02
>Company >Drugname >Inn >Product Number / Indication >Status >Generic >Biosimilar >Orphan >Marketing Authorisation >Marketing Refusal

International Patents for VIZIMPRO

When does loss-of-exclusivity occur for VIZIMPRO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

African Regional IP Organization (ARIPO)

Patent: 04
Patent: 4-phenylamino-quinazolin-6-yl-amides.
Estimated Expiration: ⤷  Try a Trial

Argentina

Patent: 8652
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05239878
Patent: 4-phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷  Try a Trial

Austria

Patent: 33490
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0510604
Patent: 4-fenilamino-quinazolin-6-il-amidas
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 65812
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷  Try a Trial

China

Patent: 72688
Patent: 4-phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷  Try a Trial

Costa Rica

Patent: 27
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷  Try a Trial

Croatia

Patent: 0110958
Estimated Expiration: ⤷  Try a Trial

Cyprus

Patent: 12127
Estimated Expiration: ⤷  Try a Trial

Denmark

Patent: 46999
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 066976
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷  Try a Trial

Eurasian Patent Organization

Patent: 1237
Patent: 4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷  Try a Trial

Patent: 0601849
Patent: 4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 46999
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷  Try a Trial

France

Patent: C1052
Estimated Expiration: ⤷  Try a Trial

Georgia, Republic of

Patent: 0084551
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
Estimated Expiration: ⤷  Try a Trial

Guatemala

Patent: 0500103
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷  Try a Trial

Honduras

Patent: 05000192
Patent: 4-FENILAMINO-QUINAZOLIN -6-IL-AMIDAS
Estimated Expiration: ⤷  Try a Trial

Hong Kong

Patent: 06432
Estimated Expiration: ⤷  Try a Trial

Hungary

Patent: 900039
Estimated Expiration: ⤷  Try a Trial

Israel

Patent: 8822
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 05757
Estimated Expiration: ⤷  Try a Trial

Patent: 66923
Estimated Expiration: ⤷  Try a Trial

Patent: 07536368
Estimated Expiration: ⤷  Try a Trial

Patent: 09007363
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDE
Estimated Expiration: ⤷  Try a Trial

Lithuania

Patent: 746999
Estimated Expiration: ⤷  Try a Trial

Patent: 2019016
Estimated Expiration: ⤷  Try a Trial

Luxembourg

Patent: 0127
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 3566
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 06012756
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS. (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES.)
Estimated Expiration: ⤷  Try a Trial

Montenegro

Patent: 267
Patent: 4-FENILAMINOKINAZOLIN-6-ILAMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 632
Patent: 4- PHENYLAMINO-QUINAZOLINE-6-YL-AMIDES
Estimated Expiration: ⤷  Try a Trial

Netherlands

Patent: 28967
Patent: 4-Fenylamino-chinazoline-6-yl-amiden.
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 0796
Patent: 4-phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷  Try a Trial

Nicaragua

Patent: 0600262
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS.
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 9692
Estimated Expiration: ⤷  Try a Trial

Patent: 19035
Estimated Expiration: ⤷  Try a Trial

Patent: 065626
Estimated Expiration: ⤷  Try a Trial

Panama

Patent: 31901
Patent: 4-FENILLAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060215
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS
Estimated Expiration: ⤷  Try a Trial

Poland

Patent: 46999
Estimated Expiration: ⤷  Try a Trial

Portugal

Patent: 46999
Estimated Expiration: ⤷  Try a Trial

Serbia

Patent: 119
Patent: 4-FENILAMINO-HINAZOLIN-6-IL-AMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Estimated Expiration: ⤷  Try a Trial

Slovenia

Patent: 46999
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0609012
Patent: 4-phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 0885835
Estimated Expiration: ⤷  Try a Trial

Patent: 070008683
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
Estimated Expiration: ⤷  Try a Trial

Patent: 080095915
Patent: 4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 74553
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 34865
Estimated Expiration: ⤷  Try a Trial

Patent: 0540163
Patent: 4-Phenylamino-quinazolin-6-yl-amides
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 06360
Patent: 4-PHENYLAMINO-QUINAZOLINE-6-YL-AMIDES
Estimated Expiration: ⤷  Try a Trial

Ukraine

Patent: 706
Patent: 4-ФЕНІЛАМІНОХІНАЗОЛІН-6-ІЛАМІДИ[4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛАМИДЫ (4-PHENYLAMINOQUINAZOLIN-6-YL AMIDES)
Estimated Expiration: ⤷  Try a Trial

Uruguay

Patent: 885
Patent: 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS REFERENCIA CRUZADA A SOLICITUD(ES) RELACIONADA(S)
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 VIZIMPRO around the world.

Country Patent Number Title Estimated Expiration
China 113952459 治疗吉非替尼耐药性癌症的方法 (Method for treating gefitinib resistant cancer) ⤷  Try a Trial
Nicaragua 200700185 MÉTODO PARA TRATAR CÁNCER RESISTENTE A GEFITINIB ⤷  Try a Trial
European Patent Office 1848414 METHODE DE TRAITEMENT DU CANCER RESISTANT AU GEFITINIB (METHOD FOR TREATING GEFITINIB RESISTANT CANCER) ⤷  Try a Trial
Taiwan 200540163 4-Phenylamino-quinazolin-6-yl-amides ⤷  Try a Trial
Lithuania C1746999 ⤷  Try a Trial
Costa Rica 8727 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS ⤷  Try a Trial
Israel 259741 שיטה לטיפול בסרטן העמיד בגפיטיניב (Method for treating gefitinib resistant cancer) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIZIMPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746999 19C1052 France ⤷  Try a Trial PRODUCT NAME: DACOMITINIB, Y COMPRIS UN DE SES HYDRATES, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/19/1354 20190404
1848414 122016000056 Germany ⤷  Try a Trial PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
1848414 C 2016 026 Romania ⤷  Try a Trial PRODUCT NAME: OSIMERTINIB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1086; DATE OF NATIONAL AUTHORISATION: 20160202; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1086; DATE OF FIRST AUTHORISATION IN EEA: 20160202
1746999 C201930055 Spain ⤷  Try a Trial PRODUCT NAME: DACOMITINIB O UNA SAL FARMACEUTICAMENTE ACEPTABLE DEL MISMO; NATIONAL AUTHORISATION NUMBER: EU/1/19/1354; DATE OF AUTHORISATION: 20190402; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1354; DATE OF FIRST AUTHORISATION IN EEA: 20190402
1746999 1990044-8 Sweden ⤷  Try a Trial PRODUCT NAME: DACOMITINIB OR APHARMACEUTICAL ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/19/1354 20190404
1746999 705 Finland ⤷  Try a Trial
1746999 301004 Netherlands ⤷  Try a Trial PRODUCT NAME: DACOMITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT ERVAN, IN HET BIJZONDER DACOMITINIB MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1354 20190404
>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.