GILOTRIF Drug Patent 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.
DrugPatentWatch® 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 June 19, 2030. 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
Summary for GILOTRIF
International Patents: | 186 |
US Patents: | 5 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 48 |
Clinical Trials: | 16 |
Patent Applications: | 666 |
Drug Prices: | Drug price information for GILOTRIF |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for GILOTRIF |
What excipients (inactive ingredients) are in GILOTRIF? | GILOTRIF excipients list |
DailyMed Link: | GILOTRIF at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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
Sponsor | Phase |
---|---|
National Cancer Centre, Singapore | Phase 1 |
Vanderbilt-Ingram Cancer Center | Phase 1 |
Santosh Kesari | Phase 1 |
Pharmacology for GILOTRIF
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein Kinase Inhibitors |
Anatomical Therapeutic Chemical (ATC) Classes for GILOTRIF
Paragraph IV (Patent) Challenges for GILOTRIF
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 GILOTRIF
GILOTRIF is protected by five US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of GILOTRIF is ⤷ Try a Trial.
This potential generic entry date is based on patent ⤷ Try a Trial.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting GILOTRIF
Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Process for preparing amino crotonyl compounds
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Solid pharmaceutical formulations comprising BIBW 2992
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Quinazoline derivatives for the treatment of cancer diseases
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Quinazoline derivatives and pharmaceutical compositions containing them
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
FDA Regulatory Exclusivity protecting GILOTRIF
FIRST-LINE TREATMENT OF METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR (EGFR) MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
Exclusivity Expiration: ⤷ Try a Trial
REVISIONS TO THE PEDIATRIC USE SUBSECTION OF LABELING TO INCLUDE THE RESULTS FROM CLINICAL STUDY 1200.120, CONDUCTED TO FULFILL A PEDIATRIC WRITTEN REQUEST
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Try a Trial
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 | ⤷ 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 GILOTRIF
When does loss-of-exclusivity occur for GILOTRIF?
Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:
Argentina
Patent: 2062
Estimated Expiration: ⤷ Try a Trial
Australia
Patent: 09254574
Estimated Expiration: ⤷ Try a Trial
Brazil
Patent: 0913379
Estimated Expiration: ⤷ Try a Trial
Canada
Patent: 26472
Estimated Expiration: ⤷ Try a Trial
Chile
Patent: 10001275
Estimated Expiration: ⤷ Try a Trial
China
Patent: 2056589
Estimated Expiration: ⤷ Try a Trial
Colombia
Patent: 80463
Estimated Expiration: ⤷ Try a Trial
Croatia
Patent: 0161061
Estimated Expiration: ⤷ Try a Trial
Cyprus
Patent: 17895
Estimated Expiration: ⤷ Try a Trial
Denmark
Patent: 99971
Estimated Expiration: ⤷ Try a Trial
Ecuador
Patent: 10010650
Estimated Expiration: ⤷ Try a Trial
Eurasian Patent Organization
Patent: 2168
Estimated Expiration: ⤷ Try a Trial
Patent: 1001852
Estimated Expiration: ⤷ Try a Trial
European Patent Office
Patent: 99971
Estimated Expiration: ⤷ Try a Trial
Hong Kong
Patent: 52478
Estimated Expiration: ⤷ Try a Trial
Hungary
Patent: 29863
Estimated Expiration: ⤷ Try a Trial
Israel
Patent: 9054
Estimated Expiration: ⤷ Try a Trial
Japan
Patent: 32367
Estimated Expiration: ⤷ Try a Trial
Patent: 11522011
Estimated Expiration: ⤷ Try a Trial
Malaysia
Patent: 1240
Estimated Expiration: ⤷ Try a Trial
Mexico
Patent: 10012939
Estimated Expiration: ⤷ Try a Trial
Montenegro
Patent: 478
Estimated Expiration: ⤷ Try a Trial
Morocco
Patent: 030
Estimated Expiration: ⤷ Try a Trial
New Zealand
Patent: 9568
Estimated Expiration: ⤷ Try a Trial
Peru
Patent: 100252
Estimated Expiration: ⤷ Try a Trial
Poland
Patent: 99971
Estimated Expiration: ⤷ Try a Trial
Portugal
Patent: 99971
Estimated Expiration: ⤷ Try a Trial
Serbia
Patent: 943
Estimated Expiration: ⤷ Try a Trial
Slovenia
Patent: 99971
Estimated Expiration: ⤷ Try a Trial
South Africa
Patent: 1007805
Estimated Expiration: ⤷ Try a Trial
South Korea
Patent: 1641517
Estimated Expiration: ⤷ Try a Trial
Patent: 110025908
Estimated Expiration: ⤷ Try a Trial
Spain
Patent: 88031
Estimated Expiration: ⤷ Try a Trial
Taiwan
Patent: 53203
Estimated Expiration: ⤷ Try a Trial
Patent: 1000472
Estimated Expiration: ⤷ Try a Trial
Tunisia
Patent: 10000557
Estimated Expiration: ⤷ Try a Trial
Ukraine
Patent: 2549
Estimated Expiration: ⤷ Try a Trial
Uruguay
Patent: 867
Estimated Expiration: ⤷ Try a Trial
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
See the table below for additional patents covering GILOTRIF around the world.
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Japan | 2004516283 | ⤷ Try a Trial | |
Brazil | PI0415424 | processo para preparação de composto de aminocrotonila | ⤷ Try a Trial |
Hungary | 228874 | QUINAZOLINE DERIVATIVES, MEDICAMENTS CONTAINING SAID COMPOUNDS, THEIR UTILIZATION AND METHOD FOR THE PRODUCTION THEREOF | ⤷ Try a Trial |
Australia | 2011201171 | Method for the production of amino crotonyl compounds | ⤷ Try a Trial |
Serbia | 60563 | POSTUPAK ZA DOBIJANJE DIMALEATNE SOLI AMINO KROTONILNIH JEDINJENJA (PROCEDURE FOR THE PREPARATION OF DIMALEATE SALT OF AMINO CROTONYL COMPOUNDS) | ⤷ Try a Trial |
World Intellectual Property Organization (WIPO) | 2011003853 | ⤷ Try a Trial | |
Australia | 2009254574 | Solid pharmaceutical formulations comprising BIBW 2992 | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GILOTRIF
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1345910 | 122014000016 | Germany | ⤷ Try a 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 | 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 | PA2014005 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925 |
1345910 | CR 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 | PA2014005,C1345910 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 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 | 6/2014 | Austria | ⤷ Try a 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 |