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VIZIMPRO Drug Profile

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When do Vizimpro patents expire, and what generic alternatives are available?

Vizimpro is a drug marketed by Pfizer Inc and is included in one NDA. There are two patents protecting this drug.

This drug has fifty-four patent family members in forty-four countries.

The generic ingredient in VIZIMPRO is dacomitinib. Two suppliers are listed for this compound. Additional details are available on the dacomitinib profile page.

US ANDA Litigation and 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 September 27, 2025. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VIZIMPRO

International Patents:	54
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	71
Clinical Trials:	2
Patent Applications:	2
Drug Prices:	Drug price information for VIZIMPRO
DailyMed Link:	VIZIMPRO at DailyMed

See drug prices for VIZIMPRO

Generic Entry Opportunity Date for VIZIMPRO

Constraining patent/regulatory exclusivity:

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

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
Cancer Institute and Hospital, Chinese Academy of Medical Sciences	Phase 2
Pfizer	Phase 2
National Cancer Centre, Singapore	Phase 2

See all VIZIMPRO clinical trials

US Patents and Regulatory Information for VIZIMPRO

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

International Patents for VIZIMPRO

Country	Patent Number	Estimated Expiration
Netherlands	1028967
Israel	178822
Japan	2007536368
Eurasian Patent Organization	200601849

Supplementary Protection Certificates for VIZIMPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	CR 2019 00043	Denmark		PRODUCT NAME: DACOMITINIB ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; 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	301004	Netherlands		PRODUCT NAME: DACOMITINIB, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, SOLVAAT OF HYDRAAT ERVAN, IN HET BIJZONDER DACOMITINIB MONOHYDRAAT; REGISTRATION NO/DATE: EU/1/19/1354 20190404
1746999	132019000000119	Italy		PRODUCT NAME: DACOMITINIB E SUOI SALI ED ESTERI(VIZIMPRO ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1354, 20190404