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Last Updated: July 5, 2020

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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 Inc and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Dacomitinib has fifty-four patent family members in forty-four countries.

Two suppliers are listed for this compound.

Summary for dacomitinib
International Patents:54
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Suppliers / Packagers: 2
Bulk Api Vendors: 69
Clinical Trials: 26
Patent Applications: 2
DailyMed Link:dacomitinib at DailyMed
Recent Clinical Trials for dacomitinib

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SponsorPhase
Guangdong Association of Clinical TrialsPhase 2
Cancer Institute and Hospital, Chinese Academy of Medical SciencesPhase 2
National Cancer Centre, 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 Inc VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer Inc VIZIMPRO dacomitinib TABLET;ORAL 211288-003 Sep 27, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Pfizer Inc VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer Inc VIZIMPRO dacomitinib TABLET;ORAL 211288-001 Sep 27, 2018 RX Yes No   Start Trial   Start Trial Y Y   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 dacomitinib

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1746999 122019000080 Germany   Start Trial PRODUCT NAME: DACOMITINIB-MONOHYDRAT; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999 PA2019016 Lithuania   Start Trial PRODUCT NAME: DAKOMITINIBO MONOHIDRATAS; REGISTRATION NO/DATE: EU/1/19/1354 20190402
1746999 2019C/540 Belgium   Start Trial PRODUCT NAME: DACOMITINIB OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT HIERVAN; AUTHORISATION NUMBER AND DATE: 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

McKesson
Merck
Johnson and Johnson
Express Scripts
Colorcon
AstraZeneca

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