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Last Updated: July 22, 2024

Dacomitinib - Generic Drug Details


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What are the generic sources for dacomitinib and what is the scope of freedom to operate?

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-four patent family members in forty-eight countries.

Two suppliers are listed for this compound.

Summary for dacomitinib
International Patents:94
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 211288-003 Sep 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-002 Sep 27, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up Y Y ⤷  Sign Up
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Japan 4205757 ⤷  Sign Up
South Korea 20070107693 METHOD FOR TREATING GEFITINIB RESISTANT CANCER ⤷  Sign Up
Israel 178822 אמידים@@-@פנילאמינו-קווינזולין-6-יל, תכשירים רפואיים המכילים אותם, ושימושם בהכנת תרופות לטיפול בהפרעות פרוליפרטיביות (4-phenylamino-quinazolin-6-yl-amides, pharmaceutical compositions comprising the same and use thereof in the preparation of medicaments for the treatment of proliferative disorders) ⤷  Sign Up
China 108421044 治疗吉非替尼耐药性癌症的方法 (METHOD FOR TREATING GEFITINIB RESISTANT CANCER) ⤷  Sign Up
Russian Federation 2007132902 СПОСОБ ЛЕЧЕНИЯ РАКА, УСТОЙЧИВОГО К ГЕФИТИНИБУ ⤷  Sign Up
Hungary S1600033 ⤷  Sign Up
Guatemala 200500103 4-FENILAMINO-QUINAZOLIN-6-IL-AMIDAS ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for dacomitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746999 C01746999/01 Switzerland ⤷  Sign Up FORMER OWNER: WARNER-LAMBERT COMPANY LLC, US
1848414 122016000056 Germany ⤷  Sign Up PRODUCT NAME: OSIMERTINIB (TAGRISSO); REGISTRATION NO/DATE: EU/1/16/1086 20160202
1746999 132019000000119 Italy ⤷  Sign Up PRODUCT NAME: DACOMITINIB E SUOI SALI ED ESTERI(VIZIMPRO ); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/19/1354, 20190404
1746999 LUC00127 Luxembourg ⤷  Sign Up PRODUCT NAME: DACOMITINIB ET SES DERIVES PHARMACEUTIQUEMENT ACCEPTABLES (VIZIMPRO ); AUTHORISATION NUMBER AND DATE: EU/1/19/1354 20190404
1848414 C20160024 00190 Estonia ⤷  Sign Up PRODUCT NAME: OSIMERTINIIB;REG NO/DATE: EU/1/16/1086 04.02.2016
1848414 CR 2016 00033 Denmark ⤷  Sign Up PRODUCT NAME: OSIMERTINIB; REG. NO/DATE: EU/1/16/1086/001-0002 20160204
1746999 2019C/540 Belgium ⤷  Sign Up DETAILS ASSIGNMENT: CHANGE OF OWNER(S), OTHER
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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