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Last Updated: March 28, 2024

AFATINIB DIMALEATE - Generic Drug Details


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What are the generic drug sources for afatinib dimaleate and what is the scope of freedom to operate?

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.

DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AFATINIB DIMALEATE
Generic Entry Date for AFATINIB DIMALEATE*:
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 AFATINIB DIMALEATE

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

SponsorPhase
Shanghai Chest HospitalPhase 4
University of WashingtonPhase 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 Strength NDA ANDAs Submitted Submissiondate
GILOTRIF Tablets afatinib dimaleate 20 mg, 30 mg and 40 mg 201292 7 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 ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial 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

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

International Patents for AFATINIB DIMALEATE

Country Patent Number Title Estimated Expiration
Taiwan I348468 ⤷  Try a Trial
Uruguay 27078 DERIVADOS DE QUINAZOLINA, MEDICAMENTOS QUE CONTIENEN ESTOS COMPUESTOS, SU EMPLEO Y PROCEDIMENTOS PARA SU PREPARACIÓN ⤷  Try a Trial
China 1867564 Process for preparing amino crotonyl compounds ⤷  Try a Trial
Portugal 1678165 ⤷  Try a Trial
Slovakia 287573 ⤷  Try a Trial
European Patent Office 1345910 DERIVES DE LA QUINAZOLINE, MEDICAMENTS CONTENANT CES COMPOSES, LEUR UTILISATION ET LEUR PROCEDE DE FABRICATION (QUINAZOLINE DERIVATIVES, MEDICAMENTS CONTAINING SAID COMPOUNDS, THEIR UTILIZATION AND METHOD FOR THE PRODUCTION THEREOF) ⤷  Try a Trial
Montenegro 02777 DERIVATI HINAZOLINA, LEKOVI KOII SADRŽE OVA JEDINJENJA, NJIHOVA PRIMENA I POSTUPAK ZA NJIHOVO PRIPREMANJE (QUINAZOLINE DERIVATIVES, MEDICAMENTS CONTAINING SAID COMPOUNDS, THEIR UTILIZATION AND METHOD FOR THE PRODUCTION THEREOF) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for AFATINIB DIMALEATE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1345910 PA2014005,C1345910 Lithuania ⤷  Try a Trial PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910 CA 2014 00006 Denmark ⤷  Try a Trial PRODUCT NAME: AFATINIB, INKLUSIVE TAUTOMERERNE, STEREOISOMERERNE OG SALTENE DERAF, EVENTUELT I FORM AF ET FYSIOLOGISK ACCEPTABELT SALT DERAF, FORTRINSVIS ET MALEATSALT DERAF OG MERE FORETRUKKET ET DIMALEATSALT DERAF; REG. NO/DATE: EU/1/13/879 20130925
1345910 C300643 Netherlands ⤷  Try a 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 92370 Luxembourg ⤷  Try a 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 1490011-2 Sweden ⤷  Try a Trial PRODUCT NAME: AFATINIB, TAUTOMERER, STEREOISOMERER OCH SALTER DAERAV, FYSIOLOGISKT GODTAGBARA SALTER MED OORGANISKA ELLER ORGANISKA SYROR ELLER BASER, SAERSKILT ETT MALEATSALT DAERAV, MER FOERETRAEDELSEVIS ETT DIMALEATSALT DAERAV; REG. NO/DATE: EU/1/13/879 20130925
1345910 14C0009 France ⤷  Try a 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 PA2014005 Lithuania ⤷  Try a 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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