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Last Updated: April 28, 2024

Dacomitinib - Generic Drug Details


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What are the generic sources for dacomitinib and what is the scope of patent protection?

Dacomitinib is the generic ingredient in one branded drug marketed by Pfizer and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dacomitinib has ninety-three patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for dacomitinib
International Patents:93
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 88
Clinical Trials: 35
Patent Applications: 1,771
What excipients (inactive ingredients) are in dacomitinib?dacomitinib excipients list
DailyMed Link:dacomitinib at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for dacomitinib
Generic Entry Date for dacomitinib*:
Constraining patent/regulatory exclusivity:
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 dacomitinib

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
MedSIRPhase 2
Daiichi Sankyo, Inc.Phase 2
Shanghai Chest HospitalPhase 1/Phase 2

See all dacomitinib clinical trials

US Patents and Regulatory Information for dacomitinib

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 211288-001 Sep 27, 2018 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes ⤷  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 dacomitinib

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 dacomitinib

Country Patent Number Title Estimated Expiration
Brazil PI0606839 uso de uma composição farmacêutica compreendendo um inibidor irreversìvel de receptor de fator de crescimento epidérmico (egfr) ⤷  Try a Trial
Japan 2007536368 ⤷  Try a Trial
China 113975393 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 dacomitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746999 122019000080 Germany ⤷  Try a Trial PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999 LUC00127 Luxembourg ⤷  Try a Trial PRODUCT NAME: DACOMITINIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VIZIMPRO ); AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404
1746999 C20190030 00298 Estonia ⤷  Try a Trial PRODUCT NAME: DAKOMITINIIB;REG NO/DATE: EU/1/19/1354 04.04.2019
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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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.