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Last Updated: April 22, 2024

Afatinib dimaleate - Generic Drug Details


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What are the generic 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
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 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 201292-001 Jul 12, 2013 RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 RX Yes No ⤷  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
>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 201292-003 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for afatinib dimaleate

Country Patent Number Title Estimated Expiration
Mexico PA03005559 DERIVADOS DE QUINAZOLINA, MEDICAMENTOS QUE CONTIENEN ESTOS COMPUESTOS, SU EMPLEO Y PROCEDIMIENTOS PARA SU PREPARACION. (QUINAZOLINE DERIVATIVES, MEDICAMENTS CONTAINING SAID COMPOUNDS, THEIR UTILIZATION AND METHOD FOR THE PRODUCTION THEREOF.) ⤷  Try a Trial
Norway 335103 ⤷  Try a Trial
Hong Kong 1152478 SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992 ⤷  Try a Trial
Montenegro 02478 ČVRSTE FARMACEUTSKE FORMULACIJE KOJE SADRŽE BIBW 2992 (SOLID PHARMACEUTICAL FORMULATIONS COMPRISING BIBW 2992) ⤷  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 2014/009 Ireland ⤷  Try a 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 2014C/009 Belgium ⤷  Try a Trial PRODUCT NAME: AFATINIB ET SES TAUTOMERES, SES STEREOISOMERES ET SES SELS PHYSIOLOGIQUEMENT ACCEPTABLES AVEC DES ACIDES OU BASES INORGANIQUES OU ORGANIQUES, EN PARTICULIER, AFATINIB SOUS FORME DE SEL DE MALEATE OU DE DIMALEATE; AUTHORISATION NUMBER AND DATE: EU/1/13/879 20130927
1345910 452 Finland ⤷  Try a Trial
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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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