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Last Updated: May 26, 2022

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 two patents protecting this drug.

This drug has fifty-five patent family members in forty-five 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 will be eligible for patent challenges on September 27, 2022. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.

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:55
US Patents:2
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 93
Clinical Trials: 5
Patent Applications: 997
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 Generic Entry Opportunity 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 two US patents and three FDA Regulatory Exclusivities.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of VIZIMPRO is See Plans and Pricing.

This potential generic entry date is based on patent See Plans and Pricing.

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

4-phenylamino-quinazolin-6-yl-amides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

4-phenylamino-quinazolin-6-yl-amides
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing
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: See Plans and Pricing

NEW CHEMICAL ENTITY
Exclusivity Expiration: See Plans and Pricing

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: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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
Estimated Expiration: See Plans and Pricing

Argentina

Patent: 8652
Estimated Expiration: See Plans and Pricing

Australia

Patent: 05239878
Estimated Expiration: See Plans and Pricing

Austria

Patent: 3490
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0510604
Estimated Expiration: See Plans and Pricing

Canada

Patent: 65812
Estimated Expiration: See Plans and Pricing

China

Patent: 72688
Estimated Expiration: See Plans and Pricing

Costa Rica

Patent: 27
Estimated Expiration: See Plans and Pricing

Croatia

Patent: 0110958
Estimated Expiration: See Plans and Pricing

Cyprus

Patent: 12127
Estimated Expiration: See Plans and Pricing

Denmark

Patent: 46999
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 066976
Estimated Expiration: See Plans and Pricing

Eurasian Patent Organization

Patent: 1237
Estimated Expiration: See Plans and Pricing

Patent: 0601849
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 46999
Estimated Expiration: See Plans and Pricing

Georgia, Republic of

Patent: 0084551
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0500103
Estimated Expiration: See Plans and Pricing

Honduras

Patent: 05000192
Estimated Expiration: See Plans and Pricing

Hong Kong

Patent: 06432
Estimated Expiration: See Plans and Pricing

Hungary

Patent: 900039
Estimated Expiration: See Plans and Pricing

Israel

Patent: 8822
Estimated Expiration: See Plans and Pricing

Japan

Patent: 05757
Estimated Expiration: See Plans and Pricing

Patent: 66923
Estimated Expiration: See Plans and Pricing

Patent: 07536368
Estimated Expiration: See Plans and Pricing

Patent: 09007363
Estimated Expiration: See Plans and Pricing

Lithuania

Patent: 746999
Estimated Expiration: See Plans and Pricing

Patent: 2019016
Estimated Expiration: See Plans and Pricing

Luxembourg

Patent: 0127
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 3566
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 06012756
Estimated Expiration: See Plans and Pricing

Montenegro

Patent: 267
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 632
Estimated Expiration: See Plans and Pricing

Netherlands

Patent: 28967
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 0796
Estimated Expiration: See Plans and Pricing

Nicaragua

Patent: 0600262
Estimated Expiration: See Plans and Pricing

Norway

Patent: 9692
Estimated Expiration: See Plans and Pricing

Patent: 19035
Estimated Expiration: See Plans and Pricing

Patent: 065626
Estimated Expiration: See Plans and Pricing

Panama

Patent: 31901
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060215
Estimated Expiration: See Plans and Pricing

Poland

Patent: 46999
Estimated Expiration: See Plans and Pricing

Portugal

Patent: 46999
Estimated Expiration: See Plans and Pricing

Serbia

Patent: 119
Estimated Expiration: See Plans and Pricing

Slovenia

Patent: 46999
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0609012
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 0885835
Estimated Expiration: See Plans and Pricing

Patent: 070008683
Estimated Expiration: See Plans and Pricing

Patent: 080095915
Estimated Expiration: See Plans and Pricing

Spain

Patent: 74553
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 34865
Estimated Expiration: See Plans and Pricing

Patent: 0540163
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 06360
Estimated Expiration: See Plans and Pricing

Ukraine

Patent: 706
Estimated Expiration: See Plans and Pricing

Uruguay

Patent: 885
Estimated Expiration: See Plans and Pricing

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
Croatia P20110958 See Plans and Pricing
Eurasian Patent Organization 200601849 4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ See Plans and Pricing
Honduras 2005000192 4-FENILAMINO-QUINAZOLIN -6-IL-AMIDAS See Plans and Pricing
Australia 2005239878 4-phenylamino-quinazolin-6-yl-amides See Plans and Pricing
Norway 339692 See Plans and Pricing
Eurasian Patent Organization 011237 4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIZIMPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746999 2019C/540 Belgium See Plans and Pricing PRODUCT NAME: DACOMITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404
1746999 C 2019 039 Romania See Plans and Pricing PRODUCT NAME: DACOMITINIB; NATIONAL AUTHORISATION NUMBER: EU/1/19/1354; DATE OF NATIONAL AUTHORISATION: 20190402; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/19/1354; DATE OF FIRST AUTHORISATION IN EEA: 20190402
1746999 2019/043 Ireland See Plans and Pricing PRODUCT NAME: DACOMITINIB MONOHYDRATE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1354/001 EU/1/19/1354/002 EU/1/19/1354/003 20190402
1746999 C201930055 Spain See Plans and Pricing 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 LUC00127 Luxembourg See Plans and Pricing PRODUCT NAME: DACOMITINIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VIZIMPRO ); AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404
1746999 350 16-2019 Slovakia See Plans and Pricing PRODUCT NAME: DAKOMITINIB; REGISTRATION NO/DATE: EU/1/19/1354 20190404
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Merck
Boehringer Ingelheim
Johnson and Johnson
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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.