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Last Updated: October 26, 2021

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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

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 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 ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013 RX Yes Yes ⤷  Free Forever Trial ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 RX Yes No ⤷  Free Forever Trial ⤷  Free Forever Trial Y ⤷  Free Forever 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 201292-003 Jul 12, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013 ⤷  Free Forever Trial ⤷  Free Forever Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 ⤷  Free Forever Trial ⤷  Free Forever 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 6/2014 Austria ⤷  Free Forever Trial PRODUCT NAME: AFATINIB, DEREN TAUTOMERE, DEREN STEREOISOMERE UND DEREN SALZE, PHYSIOLOGISCH VERTRAEGLICHE SALZE MIT ANORGANISCHEN ODER ORGANISCHEN SAEUREN ODER BASEN, BEVORZUGT DEREN MALEATSALZE, VORZUGSWEISE DEREN DIMALEATSALZE; REGISTRATION NO/DATE: EU/1/13/879 20130925
1345910 122014000016 Germany ⤷  Free Forever Trial PRODUCT NAME: AFATINIB, DIE TAUTOMEREN, DIE STEREOISOMEREN UND DIE SALZE DAVON, INSBESONDERE PHYSIOLOGISCH VERTRAEGLICHE SALZE DAVON MIT ANORGANISCHEN ODER ORGANISCHEN SAEUREN ODER BASEN, INSBESONDERE SALZE MIT MALEINSAEURE; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925
1345910 132014902231089 Italy ⤷  Free Forever 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
>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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