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Last Updated: September 22, 2020

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AFATINIB DIMALEATE - Generic Drug Details

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What are the generic 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-four 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

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

SponsorPhase
University of WashingtonPhase 1
University of California, DavisPhase 1
National Cancer Institute (NCI)Phase 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 Y   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes   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 201292-001 Jul 12, 2013   Start Trial   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013   Start Trial   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 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 C300643 Netherlands   Start Trial PRODUCT NAME: AFATINIB, DE TAUTOMEREN, STEREOISOMEREN EN ZOUTEN DAARVAN, IN HET BIJZONDER FYSIOLOGISCH AANVAARDBARE ZOUTEN MET ANORGANISCHE OF ORGANISCHE ZUREN OF BASEN, MEER IN HET BIJZONDER ZOUTEN MET MALEINEZUUR, MET NAME EEN DIMALEAATZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925
1345910 132014902231089 Italy   Start Trial PRODUCT NAME: AFATINIB, SUOI TAUTOMERI, STEREOISOMERI E SALI, SALI FISIOLOGICAMENTE ACCETTABILI CON ACIDI O BASI INORGANICI O ORGANICI, PREFERIBILMENTE UN SUO SALE MALEATO, PIU' PREFERIBILMENTE UN SUO SALE DIMALEATO(GIOTRIF); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/13/879, 20130925
1345910 92370 Luxembourg   Start Trial PRODUCT NAME: AFATINIB,LES TAUTOMERES,LES STEREOISOMERES ET LES SELS DE CELUI-CI,DES SELS PHYSIOLOGIQUEMENT ACCEPTABLES DE CELUI-CI AVEC DES ACIDES OU BASES ORGANIQUES OU INORGANIQUES,DE PREFERENCE UN SEL MALEATE DE CELUI-CI,ET PLUS DE PREFERENCE UN SEL DIMALEATE DE CELUI-CI
1345910 PA2014005,C1345910 Lithuania   Start Trial PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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