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.
Summary for afatinib dimaleate
International Patents: | 186 |
US Patents: | 5 |
Tradenames: | 1 |
Applicants: | 1 |
NDAs: | 1 |
Drug Master File Entries: | 6 |
Finished Product Suppliers / Packagers: | 1 |
Raw Ingredient (Bulk) Api Vendors: | 46 |
Clinical Trials: | 9 |
Patent Applications: | 1,972 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for afatinib dimaleate |
DailyMed Link: | afatinib dimaleate at DailyMed |
Recent Clinical Trials for afatinib dimaleate
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Sponsor | Phase |
---|---|
Shanghai Chest Hospital | Phase 4 |
University of Washington | Phase 1 |
University of California, Davis | Phase 1 |
Pharmacology for afatinib dimaleate
Drug Class | Kinase Inhibitor |
Mechanism of Action | Protein 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
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 | See Plans and Pricing | See Plans and Pricing |
Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | Jul 12, 2013 | See Plans and Pricing | See Plans and Pricing |
Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | See Plans and Pricing | See Plans and Pricing |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for afatinib dimaleate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Croatia | P20161061 | See Plans and Pricing | |
Norway | 325672 | See Plans and Pricing | |
South Korea | 20060120121 | METHOD FOR THE PRODUCTION OF AMINO CROTONYL COMPOUNDS | See Plans and Pricing |
World Intellectual Property Organization (WIPO) | 2009147238 | See Plans and Pricing | |
Australia | 2009254574 | Solid pharmaceutical formulations comprising BIBW 2992 | See Plans and Pricing |
South Korea | 100852102 | See Plans and Pricing | |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for afatinib dimaleate
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
1345910 | 14C0009 | France | See Plans and Pricing | 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 | C300643 | Netherlands | See Plans and Pricing | PRODUCT NAME: AFATINIB, DE TAUTOMEREN, STEREOISOMEREN EN ZOUTEN DAARVAN, IN HET BIJZONDER FYSIOLOGISCH AANVAARDBARE ZOUTEN MET ANORGANISCHE OF ORGANISCHE ZUREN OF BASEN, MEER IN HET BIJZONDER ZOUTEN MET MALEINEZUUR, MET NAME EEN DIMALEAATZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/13/879/001-012 20130925 |
1345910 | CR 2014 00006 | Denmark | See Plans and Pricing | 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 | 1490011-2 | Sweden | See Plans and Pricing | 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 | 122014000016 | Germany | See Plans and Pricing | 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 | C01345910/01 | Switzerland | See Plans and Pricing | PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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