VIZIMPRO Drug Patent Profile

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

See drug prices for VIZIMPRO

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for VIZIMPRO

NDA:

211288

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

See all VIZIMPRO clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for VIZIMPRO

L01EB	Epidermal growth factor receptor (EGFR) tyrosine kinase inhibitors
L01E	PROTEIN KINASE INHIBITORS
L01	ANTINEOPLASTIC AGENTS
L	Antineoplastic and immunomodulating agents

US Patents and Regulatory Information for VIZIMPRO

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

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

FDA Regulatory Exclusivity protecting VIZIMPRO

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
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No			Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes			Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-002	Sep 27, 2018		RX	Yes	No
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes

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)

Argentina

Australia

Austria

Brazil

Canada

China

Costa Rica

Croatia

Cyprus

Denmark

Ecuador

Eurasian Patent Organization

European Patent Office

Georgia, Republic of

Guatemala

Honduras

Hong Kong

Hungary

Israel

Japan

Lithuania

Luxembourg

Malaysia

Mexico

Montenegro

Morocco

Netherlands

New Zealand

Nicaragua

Norway

Panama

Peru

Poland

Portugal

Serbia

Slovenia

South Africa

South Korea

Spain

Taiwan

Tunisia

Ukraine

Uruguay

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
Eurasian Patent Organization	200601849	4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ
Honduras	2005000192	4-FENILAMINO-QUINAZOLIN -6-IL-AMIDAS
Australia	2005239878	4-phenylamino-quinazolin-6-yl-amides
Norway	339692
Eurasian Patent Organization	011237	4-ФЕНИЛАМИНОХИНАЗОЛИН-6-ИЛ-АМИДЫ (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)

Supplementary Protection Certificates for VIZIMPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	2019C/540	Belgium		PRODUCT NAME: DACOMITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404
1746999	C 2019 039	Romania		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		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		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		PRODUCT NAME: DACOMITINIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VIZIMPRO ); AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404
1746999	350 16-2019	Slovakia		PRODUCT NAME: DAKOMITINIB; REGISTRATION NO/DATE: EU/1/19/1354 20190404