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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-four 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:	94
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	29
Clinical Trials:	5
Patent Applications:	154
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VIZIMPRO

Generic Entry Date for VIZIMPRO^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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

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 ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

4-phenylamino-quinazolin-6-yl-amides
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up

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: ⤷ Sign Up

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Glossary

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

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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

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

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Country	Patent Number	Title	Estimated Expiration
Slovenia	1746999		⤷ Sign Up
World Intellectual Property Organization (WIPO)	2006084058		⤷ Sign Up
Norway	20074366		⤷ Sign Up
Costa Rica	8727	4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS	⤷ Sign Up
Austria	E533490		⤷ Sign Up
Montenegro	01267	4-FENILAMINOKINAZOLIN-6-ILAMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES)	⤷ Sign Up
Hungary	S1900039		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for VIZIMPRO

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	C201930055	Spain	⤷ Sign Up	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
1848414	C 2016 026	Romania	⤷ Sign Up	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	C 2019 039	Romania	⤷ Sign Up	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
1848414	300824	Netherlands	⤷ Sign Up	PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160204
1746999	2019C/540	Belgium	⤷ Sign Up	DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
1746999	2019/043	Ireland	⤷ Sign Up	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	C01746999/01	Switzerland	⤷ Sign Up	FORMER OWNER: WARNER-LAMBERT COMPANY LLC, US
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description