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VIZIMPRO Drug Profile

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Which patents cover Vizimpro, and when can generic versions of Vizimpro launch?

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-three 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:	53
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Bulk Api Vendors:	68
Clinical Trials:	1
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
Pfizer	Phase 2
National Cancer Centre, Singapore	Phase 2

See all VIZIMPRO clinical trials

Synonyms for VIZIMPRO

(2E)-N-[4-(3-chloro-4-fluoroanilino)-7-methoxyquinazolin-6-yl]-4-(piperidin-1-yl)but-2-enamide

(2E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxy-6-quinazolinyl]-4-(1-piperidinyl)-2-butenamide

(2e)-N-{4-[(3-Chloro-4-Fluorophenyl)amino]-7-Methoxyquinazolin-6-Yl}-4-(Piperidin-1-Yl)but-2-Enamide

(E)-N-(4-((3-chloro-4-fluorophenyl)aMino)-7-Methoxyquinazolin-6-yl)-4-(piperidin-1-yl)but-2-enaMide

(E)-N-[4-[(3-Chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl]-4-(piperidin-1-yl)but-2-enamide

(E)-N-[4-[(3-chloro-4-fluorophenyl)amino]-7-methoxyquinazolin-6-yl]-4-piperidin-1-ylbut-2-enamide

1110813-31-4

1110813-31-4 pound not PF 299804 pound not PF-299804

2-Butenamide, N-(4-((3-chloro-4-fluorophenyl)amino)-7-methoxy-6-quinazolinyl)-4-(1-piperidinyl)-, (2E)-

2XJX250C20

AB0035896

ABP000126

AC-25915

AKOS025401818

AOB87383

AOB87735

BC261945

BCP02530

BDBM112499

C24H25ClFN5O2

CHEBI:132268

CHEBI:91466

CHEMBL2110732

CS-0500

D09883

D5450

Dacomitinib

Dacomitinib (INN)

Dacomitinib (PF299804, PF-00299804)

Dacomitinib (PF299804, PF299)

Dacomitinib (PF299804)

Dacomitinib [USAN:INN]

Dacomitinib anhydrous

Dacomitinib, PF299804

dacomitinibum

DB11963

DTXSID50149493

EX-A030

GTPL7422

HY-13272

J-500784

MFCD19443734

MLS006011275

NCGC00263185-09

PF 00299804

PF 00299804-03

PF-00299804

PF-00299804 dacomitinib

PF-00299804-03

PF-299

PF-299804

PF-299804 (Dacomitinib PF-00299804)

pf00299804

PF299

PF299804

PF299804|||PF299

Q-4059

QCR-174

RL00451

s2727

SB21754

SC-94589

SMR004703025

SW219155-1

UNII-2XJX250C20

US8623883, No. 2

Y0338

ZINC72266312

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

International Patents for VIZIMPRO

Country	Patent Number	Estimated Expiration
Croatia	P20110958
Mexico	PA06012756
Georgia, Republic of	P20084551
Ecuador	SP066976
South Korea	20070008683

Supplementary Protection Certificates for VIZIMPRO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1746999	122019000080	Germany		PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999	PA2019016	Lithuania		PRODUCT NAME: DAKOMITINIBO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1354 20190402
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	2019C/540	Belgium		PRODUCT NAME: DACOMITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404