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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 four patents protecting this drug.

This drug has ninety-three 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

Summary for vizimpro

International Patents:	93
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

See drug prices for vizimpro

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) 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 four US patents and two 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
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-001	Sep 27, 2018		RX	Yes	No			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			Y	Y
Pfizer	VIZIMPRO	dacomitinib	TABLET;ORAL	211288-003	Sep 27, 2018		RX	Yes	Yes

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

International Patents for vizimpro

See the table below for patents covering vizimpro around the world.

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2007132902	СПОСОБ ЛЕЧЕНИЯ РАКА, УСТОЙЧИВОГО К ГЕФИТИНИБУ
Brazil	PI0606839	uso de uma composição farmacêutica compreendendo um inibidor irreversìvel de receptor de fator de crescimento epidérmico (egfr)
Norway	339692
China	108421044	治疗吉非替尼耐药性癌症的方法 (METHOD FOR TREATING GEFITINIB RESISTANT CANCER)
European Patent Office	1746999	4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)
Netherlands	1028967	4-Fenylamino-chinazoline-6-yl-amiden.

Supplementary Protection Certificates for vizimpro

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	1990044-8	Sweden		PRODUCT NAME: DACOMITINIB OR APHARMACEUTICAL ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/19/1354 20190404
1746999	LUC00127	Luxembourg		PRODUCT NAME: DACOMITINIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VIZIMPRO ); AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404
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	C20190030 00298	Estonia		PRODUCT NAME: DAKOMITINIIB;REG NO/DATE: EU/1/19/1354 04.04.2019
1848414	C 2016 026	Romania		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	43/2019	Austria		PRODUCT NAME: DACOMITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DACOMITINIBMONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 (MITTEILUNG) 20190404