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: | 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 |
National Cancer Institute (NCI) | 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
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 | 201292-002 | Jul 12, 2013 | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
Boehringer Ingelheim | GILOTRIF | afatinib dimaleate | TABLET;ORAL | 201292-003 | Jul 12, 2013 | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | |||
>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 afatinib dimaleate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
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 | 201292-001 | 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 |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for afatinib dimaleate
Country | Patent Number | Title | Estimated Expiration |
---|---|---|---|
Cyprus | 1117895 | ⤷ Try a Trial | |
China | 1277822 | ⤷ Try a Trial | |
Portugal | 2451445 | ⤷ 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 | 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 | 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 |
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