Afatinib dimaleate - Generic Drug Details
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What are the generic drug sources for afatinib dimaleate and what is the scope of patent protection?
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 |
Anatomical Therapeutic Chemical (ATC) Classes for afatinib dimaleate
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 | 201292-003 | 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 afatinib dimaleate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Serbia | 50860 | DERIVATI HINAZOLINA, LEKOVI KOJI 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 |
Taiwan | 200526644 | Process for preparing amino crotonyl compounds | ⤷ Try a Trial |
Canada | 2759063 | DIMALEATE DE 4-[(3-CHLORO-4-FLUOROPHENYL)AMINO]-6-{[4-(N,N-DIETHYLAMINO)-1-OXOBUT-2-EN-1-YL]AMINO}-7-((S)-TETRAHYDROFURAN-3-YLOXY)-QUINAZOLINE ET SON UTILISATION (4-[(3-CHLORO-4-FLUOROPHENYL)AMINO]-6-{[4-(N,N-DIMETHYLAMINO)-1-OXO-2-BUTEN-1-YL]AMINO}-7-((S)-TETRAHYDROFURAN-3-YLOXY)-QUINAZOLINE DIMALEATE AND THE USE THEREOF) | ⤷ Try a Trial |
Eurasian Patent Organization | 022168 | СПОСОБ ПОЛУЧЕНИЯ УПЛОТНЕННОГО ПРОМЕЖУТОЧНОГО ПРОДУКТА ДИМАЛЕАТА BIBW 2992 И ТВЕРДЫЕ ТАБЛЕТКИ, ПОЛУЧЕННЫЕ ИЗ ТАКОГО ПРОДУКТА (METHOD FOR PRODUCTION OF COMPACTED INTERMEDIATE DIMALEATE BIBW 2992 AND SOLID TABLETS PREPARED FROM SUCH INTERMEDIATE) | ⤷ Try a Trial |
Montenegro | P59508 | ⤷ Try a Trial | |
Peru | 20100252 | NUEVAS FORMULACIONES FARMACEUTICAS SOLIDAS QUE COMPRENDEN DIMALEATO DE 4-[(3-CLORO-4-FLUOROFENIL) AMINO]-6-{[4-(N,N-DIMETILAMINO)-1-OXO-2-BUTEN-1-IL] AMINO}-7-((S)-TETRAHIDROFURAN-3-ILOXI)-QUINAZOLINA | ⤷ Try a Trial |
Uruguay | 28559 | PROCEDIMIENTO PARA LA PREPARACIÓN DE COMPUESTOS DE AMINOCROTONILO | ⤷ 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 | C01345910/01 | Switzerland | ⤷ Try a Trial | PRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014 |
1345910 | SPC/GB14/015 | United Kingdom | ⤷ Try a Trial | PRODUCT NAME: AFATINIB, OPTIONALLY IN THE FORM OF A PHYSIOLOGICALLY ACCEPTABLE SALT, IN PARTICULAR A SALT WITH MALEIC ACID; REGISTERED: UK EU/1/13/879/001 20130927; UK EU/1/13/879/002 20130927; UK EU/1/13/879/003 20130927; UK EU/1/13/879/004 20130927; UK EU/1/13/879/005 20130927; UK EU/1/13/879/006 20130927; UK EU/1/13/879/007 20130927; UK EU/1/13/879/008 20130927; UK EU/1/13/879/009 20130927; UK EU/1/13/879/010 20130927; UK EU/1/13/879/011 20130927; UK EU/1/13/879/012 20130927 |
1345910 | C 2014 005 | Romania | ⤷ Try a Trial | PRODUCT NAME: AFATINIB,TAUTOMERII, STEREOIZOMERII SI SARURILE ACESTUIA, SARURI FIZIOLOGIC ACCEPTABILE CU ACIZI SAU BAZE ANORGANICE SAUORGANICE, PREFERABIL O SARE MALEAT A ACESTUIA, SI MAI PREFERABIL SARE DIMALEATAACESTUIA; NATIONAL AUTHORISATION NUMBER: EU/1/13/879; DATE OF NATIONAL AUTHORISATION: 20130925; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/13/879; DATE OF FIRST AUTHORISATION IN EEA: 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 | 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 |
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 |
>Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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