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Last Updated: November 26, 2020

DrugPatentWatch Database Preview

Afatinib dimaleate - Generic Drug Details

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What are the generic drug sources for afatinib dimaleate and what is the scope of patent protection?

Afatinib dimaleate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Afatinib dimaleate has one hundred and eighty-six patent family members in forty-six countries.

There are six drug master file entries for afatinib dimaleate. One supplier is listed for this compound.

Recent Clinical Trials for afatinib dimaleate

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SponsorPhase
University of WashingtonPhase 1
National Cancer Institute (NCI)Phase 1
University of California, DavisPhase 1

See all afatinib dimaleate clinical trials

Pharmacology for afatinib dimaleate
Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Paragraph IV (Patent) Challenges for AFATINIB DIMALEATE
Tradename Dosage Ingredient NDA Submissiondate
GILOTRIF TABLET;ORAL afatinib dimaleate 201292 2017-07-12

US Patents and Regulatory Information for afatinib dimaleate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for afatinib dimaleate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013   Start Trial   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013   Start Trial   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Supplementary Protection Certificates for afatinib dimaleate

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345910 14C0009 France   Start Trial PRODUCT NAME: AFATINIB,SES TAUTOMERES,SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES,EN PARTICULIER LE MALEATE OU LE DIMALEATE.; REGISTRATION NO/DATE: EU/1/13/879 20130925
1345910 2014/009 Ireland   Start Trial PRODUCT NAME: AFATINIB, THE TAUTOMERS, THE STEREOISOMERS AND THE SALTS THEREOF, OPTIONALLY IN THE FORM OF PHYSIOLOGICALLY ACCEPTABLE SALTS THEREOF WITH INORGANIC OR ORGANIC ACIDS OR BASES, PREFERABLY SALTS WITH MALEIC ACID; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925
1345910 C 2014 005 Romania   Start Trial PRODUCT NAME: AFATINIB,TAUTOMERII, STEREOIZOMERII SI SARURILE ACESTUIA, SARURI FIZIOLOGIC ACCEPTABILE CU ACIZI SAU BAZE ANORGANICE SAUORGANICE, PREFERABIL O SARE MALEAT A ACESTUIA, SI MAI PREFERABIL SARE DIMALEATAACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/879; DATE OF NATIONAL AUTHORISATION: 20130925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/879; DATE OF FIRST AUTHORISATION IN EEA: 20130925
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Harvard Business School
Johnson and Johnson
Boehringer Ingelheim
Mallinckrodt
AstraZeneca
McKesson

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