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Last Updated: April 19, 2021

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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 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

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Summary for VIZIMPRO
International Patents:55
US Patents:2
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 74
Clinical Trials: 3
Patent Applications: 691
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
Drug Prices for VIZIMPRO

See drug prices for VIZIMPRO

DrugPatentWatch® Estimated Generic Entry Opportunity Date for VIZIMPRO
Generic Entry Date for VIZIMPRO*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2
Fondazione Ricerca TraslazionalePhase 2
National Cancer Centre, SingaporePhase 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 VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes   Start Trial   Start Trial Y Y   Start Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for VIZIMPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746999 43/2019 Austria   Start Trial PRODUCT NAME: DACOMITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DACOMITINIBMONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 (MITTEILUNG) 20190404
1746999 301004 Netherlands   Start Trial 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 C20190030 00298 Estonia   Start Trial PRODUCT NAME: DAKOMITINIIB;REG NO/DATE: EU/1/19/1354 04.04.2019
1746999 132019000000119 Italy   Start Trial PRODUCT NAME: DACOMITINIB E SUOI SALI ED ESTERI(VIZIMPRO ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1354, 20190404
1746999 1990044-8 Sweden   Start Trial PRODUCT NAME: DACOMITINIB OR APHARMACEUTICAL ACCEPTABLE SALT THEROF; REG. NO/DATE: EU/1/19/1354 20190404
1746999 PA2019016,C1746999 Lithuania   Start Trial PRODUCT NAME: DAKOMITINIBO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1354 20190402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Merck
Boehringer Ingelheim
Johnson and Johnson
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.