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Afatinib dimaleate - Generic Drug Details

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Afatinib dimaleate is the generic ingredient in one branded drug marketed by Boehringer Ingelheim and is included in one NDA. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has one hundred and twenty-eight patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for Generic Name: afatinib dimaleate

Tradenames:1
Patents:4
Applicants:1
NDAs:1
Drug Master File Entries: 0
Suppliers / Packaging: see list1
Drug Prices:see low prices

Pharmacology for Ingredient: afatinib dimaleate

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYes► subscribe► subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXNo► subscribe► subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-002Jul 12, 2013RXNo8,545,884► subscribeY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: afatinib dimaleate

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,586,608Quinazoline derivatives and pharmaceutical compositions containing them► subscribe
7,019,012Quinazoline derivatives and pharmaceutical compositions containing them► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: afatinib dimaleate

Country Document Number Estimated Expiration
New Zealand589568► subscribe
Luxembourg92370► subscribe
Peru02672010► subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AFATINIB DIMALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014 00006Denmark► subscribePRODUCT 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
1345910/01Switzerland► subscribePRODUCT NAME: AFATINIB; REGISTRATION NO/DATE: SWISSMEDIC 63042 17.01.2014
90011-2Sweden► subscribePRODUCT 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
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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 verifification 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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