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Last Updated: December 5, 2020

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GILOTRIF Drug Profile

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Which patents cover Gilotrif, and what generic alternatives are available?

Gilotrif is a drug marketed by Boehringer Ingelheim and is included in one NDA. There are five patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and eighty-six patent family members in forty-six countries.

The generic ingredient in GILOTRIF is afatinib dimaleate. There are six drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the afatinib dimaleate profile page.

US ANDA Litigation and Generic Entry Outlook for Gilotrif

Gilotrif was eligible for patent challenges on July 12, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 19, 2029. This may change due to patent challenges or generic licensing.

There have been five patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for GILOTRIF
Drug Prices for GILOTRIF

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Generic Entry Opportunity Date for GILOTRIF
Generic Entry Date for GILOTRIF*:
Constraining patent/regulatory exclusivity:
NDA:
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 GILOTRIF

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

SponsorPhase
Vanderbilt-Ingram Cancer CenterPhase 1
National Cancer Centre, SingaporePhase 1
Boehringer IngelheimPhase 1

See all GILOTRIF clinical trials

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

US Patents and Regulatory Information for GILOTRIF

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 201292-001 Jul 12, 2013 RX Yes No   Start Trial   Start Trial Y   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013 RX Yes No   Start Trial   Start Trial   Start Trial
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 GILOTRIF

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 201292-002 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 GILOTRIF

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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 PA2014005 Lithuania   Start Trial PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
1345910 CA 2014 00006 Denmark   Start 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 C01345910/01 Switzerland   Start Trial PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
1345910 6/2014 Austria   Start 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Colorcon
Boehringer Ingelheim
Baxter
Johnson and Johnson
Harvard Business School
Merck

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