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
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 |


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
Sponsor | Phase |
---|---|
Samsung Medical Center | Phase 2 |
Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Phase 2 |
Fondazione Ricerca Traslazionale | Phase 2 |
Anatomical Therapeutic Chemical (ATC) Classes for VIZIMPRO
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
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 |