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Last Updated: May 29, 2023

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 patent family members in forty-seven countries.

Two suppliers are listed for this compound.

Summary for dacomitinib
International Patents:90
US Patents:4
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 2
Raw Ingredient (Bulk) Api Vendors: 85
Clinical Trials: 34
Patent Applications: 2,291
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
Shanghai Chest HospitalPhase 1/Phase 2
Singapore Translational Cancer ConsortiumPhase 2
Genome Institute of SingaporePhase 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 ⤷  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 ⤷  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 211288-002 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 ⤷  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
>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
Montenegro 01267 4-FENILAMINOKINAZOLIN-6-ILAMIDI (4-PHENYLAMINO-QUINAZOLIN-6-YL-AMIDES) ⤷  Try a Trial
Cyprus 1111676 ⤷  Try a Trial
South Africa 200706804 Method for treating gefitinib resistant cancer ⤷  Try a Trial
China 102886045 Method for treating gefitinib resistant cancer ⤷  Try a Trial
Denmark 1746999 ⤷  Try a Trial
Japan 4205757 ⤷  Try a Trial
Israel 184791 תרכובות המיועדות לטיפול בסרטן העמיד לגפיטיניב שיטה לטיפול בסרטן העמיד בגפיטיניב עם מוטציה t790m בגן egfr באמצעות מעכבי egfr בלתי הפיכים (Compositions for treating gefitlnib resistant cancers having egfr t790m mutation using irreversible egfr inhibitors) ⤷  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 2019/043 Ireland ⤷  Try a Trial PRODUCT NAME: DACOMITINIB MONOHYDRATE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTRATION NO/DATE: EU/1/19/1354/001 EU/1/19/1354/002 EU/1/19/1354/003 20190402
1746999 PA2019016,C1746999 Lithuania ⤷  Try a Trial PRODUCT NAME: DAKOMITINIBO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999 122019000080 Germany ⤷  Try a Trial PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999 705 Finland ⤷  Try a Trial
1746999 301004 Netherlands ⤷  Try a 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 43/2019 Austria ⤷  Try a Trial PRODUCT NAME: DACOMITINIB ODER EIN PHARMAZEUTISCH ANNEHMBARES SALZ DAVON, INSBESONDERE DACOMITINIBMONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 (MITTEILUNG) 20190404
1848414 C20160024 00190 Estonia ⤷  Try a Trial PRODUCT NAME: OSIMERTINIIB;REG NO/DATE: EU/1/16/1086 04.02.2016
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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