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Last Updated: May 18, 2024

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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-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

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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
Drug patent expirations by year for VIZIMPRO
Drug Prices for VIZIMPRO

See drug prices for VIZIMPRO

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Samsung Medical CenterPhase 2
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2
Fondazione Ricerca TraslazionalePhase 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

4-phenylamino-quinazolin-6-yl-amides
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial

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: ⤷  Try a Trial

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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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.

Country Patent Number Title Estimated Expiration
France 19C1052 ⤷  Try a Trial
Germany 602006021142 ⤷  Try a Trial
Australia 2005239878 4-phenylamino-quinazolin-6-yl-amides ⤷  Try a Trial
China 113952459 治疗吉非替尼耐药性癌症的方法 (Method for treating gefitinib resistant cancer) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VIZIMPRO

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746999 C 2019 039 Romania ⤷  Try a Trial 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
1746999 19C1052 France ⤷  Try a Trial PRODUCT NAME: DACOMITINIB, Y COMPRIS UN DE SES HYDRATES, OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/19/1354 20190404
1848414 CR 2016 00033 Denmark ⤷  Try a Trial PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1746999 122019000080 Germany ⤷  Try a Trial PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

Make Better Decisions: Try a trial or see plans & pricing

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.