GILOTRIF Drug Patent Profile
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Which patents cover Gilotrif, and when can generic versions of Gilotrif launch?
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
*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 ⤷ Sign Up.
This potential generic entry date is based on patent ⤷ Sign Up.
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: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Process for preparing amino crotonyl compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Solid pharmaceutical formulations comprising BIBW 2992
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Quinazoline derivatives for the treatment of cancer diseases
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Quinazoline derivatives and pharmaceutical compositions containing them
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
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: ⤷ Sign Up
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: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
PEDIATRIC EXCLUSIVITY
Exclusivity Expiration: ⤷ Sign Up
| 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 | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-001 | Jul 12, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-001 | Jul 12, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | RX | Yes | No | ⤷ Sign Up | ⤷ Sign Up | Y | ⤷ Sign Up | |||
| >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 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | ⤷ Sign Up | ⤷ Sign Up |
| >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: ⤷ Sign Up
Australia
Patent: 09254574
Estimated Expiration: ⤷ Sign Up
Brazil
Patent: 0913379
Estimated Expiration: ⤷ Sign Up
Canada
Patent: 26472
Estimated Expiration: ⤷ Sign Up
Chile
Patent: 10001275
Estimated Expiration: ⤷ Sign Up
China
Patent: 2056589
Estimated Expiration: ⤷ Sign Up
Colombia
Patent: 80463
Estimated Expiration: ⤷ Sign Up
Croatia
Patent: 0161061
Estimated Expiration: ⤷ Sign Up
Cyprus
Patent: 17895
Estimated Expiration: ⤷ Sign Up
Denmark
Patent: 99971
Estimated Expiration: ⤷ Sign Up
Ecuador
Patent: 10010650
Estimated Expiration: ⤷ Sign Up
Eurasian Patent Organization
Patent: 2168
Estimated Expiration: ⤷ Sign Up
Patent: 1001852
Estimated Expiration: ⤷ Sign Up
European Patent Office
Patent: 99971
Estimated Expiration: ⤷ Sign Up
Hong Kong
Patent: 52478
Estimated Expiration: ⤷ Sign Up
Hungary
Patent: 29863
Estimated Expiration: ⤷ Sign Up
Israel
Patent: 9054
Estimated Expiration: ⤷ Sign Up
Japan
Patent: 32367
Estimated Expiration: ⤷ Sign Up
Patent: 11522011
Estimated Expiration: ⤷ Sign Up
Malaysia
Patent: 1240
Estimated Expiration: ⤷ Sign Up
Mexico
Patent: 10012939
Estimated Expiration: ⤷ Sign Up
Montenegro
Patent: 478
Estimated Expiration: ⤷ Sign Up
Morocco
Patent: 030
Estimated Expiration: ⤷ Sign Up
New Zealand
Patent: 9568
Estimated Expiration: ⤷ Sign Up
Peru
Patent: 100252
Estimated Expiration: ⤷ Sign Up
Poland
Patent: 99971
Estimated Expiration: ⤷ Sign Up
Portugal
Patent: 99971
Estimated Expiration: ⤷ Sign Up
Serbia
Patent: 943
Estimated Expiration: ⤷ Sign Up
Slovenia
Patent: 99971
Estimated Expiration: ⤷ Sign Up
South Africa
Patent: 1007805
Estimated Expiration: ⤷ Sign Up
South Korea
Patent: 1641517
Estimated Expiration: ⤷ Sign Up
Patent: 110025908
Estimated Expiration: ⤷ Sign Up
Spain
Patent: 88031
Estimated Expiration: ⤷ Sign Up
Taiwan
Patent: 53203
Estimated Expiration: ⤷ Sign Up
Patent: 1000472
Estimated Expiration: ⤷ Sign Up
Tunisia
Patent: 10000557
Estimated Expiration: ⤷ Sign Up
Ukraine
Patent: 2549
Estimated Expiration: ⤷ Sign Up
Uruguay
Patent: 867
Estimated Expiration: ⤷ Sign Up
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 | 5695680 | ⤷ Sign Up | |
| World Intellectual Property Organization (WIPO) | 2005037824 | ⤷ Sign Up | |
| Denmark | 2299971 | ⤷ Sign Up | |
| Japan | 5963672 | ⤷ Sign Up | |
| South Korea | 20120037987 | METHOD FOR THE PRODUCTION OF AMINO CROTONYL COMPOUNDS | ⤷ Sign Up |
| Canada | 2833706 | DERIVES DE QUINAZOLINE POUR LE TRAITEMENT DES AFFECTIONS CANCEREUSES (QUINAZOLINE DERIVATIVES FOR THE TREATMENT OF CANCER DISEASES) | ⤷ Sign Up |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for GILOTRIF
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 1345910 | 1490011-2 | Sweden | ⤷ Sign Up | 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 | ⤷ Sign Up | 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,C1345910 | Lithuania | ⤷ Sign Up | PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925 |
| 1345910 | C01345910/01 | Switzerland | ⤷ Sign Up | PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014 |
| 1345910 | 132014902231089 | Italy | ⤷ Sign Up | 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 | 92370 | Luxembourg | ⤷ Sign Up | 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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