AFATINIB DIMALEATE - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug 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: | 48 |
Clinical Trials: | 9 |
Patent Applications: | 1,394 |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for AFATINIB DIMALEATE |
DailyMed Link: | AFATINIB DIMALEATE at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for AFATINIB DIMALEATE
Generic Entry Date for AFATINIB DIMALEATE*:
Constraining patent/regulatory exclusivity:
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 AFATINIB DIMALEATE
Identify potential brand extensions & 505(b)(2) entrants
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 | ⤷ Try a Trial | ⤷ Try a Trial |
Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-002 | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for AFATINIB DIMALEATE
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Taiwan | I348468 | ⤷ Try a Trial | |
Uruguay | 27078 | DERIVADOS DE QUINAZOLINA, MEDICAMENTOS QUE CONTIENEN ESTOS COMPUESTOS, SU EMPLEO Y PROCEDIMENTOS PARA SU PREPARACIÓN | ⤷ Try a Trial |
China | 1867564 | Process for preparing amino crotonyl compounds | ⤷ Try a Trial |
Portugal | 1678165 | ⤷ Try a Trial | |
Slovakia | 287573 | ⤷ Try a Trial | |
European Patent Office | 1345910 | DERIVES DE LA QUINAZOLINE, MEDICAMENTS CONTENANT CES COMPOSES, LEUR UTILISATION ET LEUR PROCEDE DE FABRICATION (QUINAZOLINE DERIVATIVES, MEDICAMENTS CONTAINING SAID COMPOUNDS, THEIR UTILIZATION AND METHOD FOR THE PRODUCTION THEREOF) | ⤷ Try a Trial |
Montenegro | 02777 | DERIVATI HINAZOLINA, LEKOVI KOII SADRŽE OVA JEDINJENJA, NJIHOVA PRIMENA I POSTUPAK ZA NJIHOVO PRIPREMANJE (QUINAZOLINE DERIVATIVES, MEDICAMENTS CONTAINING SAID COMPOUNDS, THEIR UTILIZATION AND METHOD FOR THE PRODUCTION THEREOF) | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for AFATINIB DIMALEATE
Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
---|---|---|---|---|
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 | CA 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 | C300643 | Netherlands | ⤷ Try a Trial | 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 | 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 | 1490011-2 | Sweden | ⤷ Try a Trial | 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 | ⤷ Try a Trial | 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 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925 |
>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.