.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Obtain formulation and manufacturing information
  • Set up watchlists for daily email updates

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

Afatinib dimaleate - Generic Drug Details

« Back to Dashboard

What are the generic drug sources, and freedom to operate, for afatinib dimaleate?

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

Afatinib dimaleate has one hundred and forty-four patent family members in forty-four countries.

One supplier is listed for this compound.

Summary for Generic Name: afatinib dimaleate

Tradenames:1
Patents:6
Applicants:1
NDAs:1
Suppliers / Packagers: see list1
Bulk Api Vendors: see list14
Clinical Trials: see list30
Patent Applications: see list3
Drug Prices:see low prices
DailyMed Link:afatinib dimaleate at DailyMed

Pharmacology for Ingredient: afatinib dimaleate

Drug ClassKinase Inhibitor
Mechanism of ActionProtein Kinase Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYesRE43431► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYes► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-001Jul 12, 2013RXYesNo► Subscribe► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-003Jul 12, 2013RXYesYes8,545,884► SubscribeY ► Subscribe
Boehringer Ingelheim
GILOTRIF
afatinib dimaleate
TABLET;ORAL201292-001Jul 12, 2013RXYesNoRE43431► SubscribeY ► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
8,404,697Quinazoline derivatives for the treatment of cancer diseases► Subscribe
9,089,571Quinazoline derivatives for the treatment of cancer diseases► Subscribe
8,586,608Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
7,019,012Quinazoline derivatives and pharmaceutical compositions containing them► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: afatinib dimaleate

Country Document Number Estimated Expiration
Morocco34030► Subscribe
South Korea101180752► Subscribe
Eurasian Patent Organization022168► Subscribe
Argentina040524► Subscribe
Japan4594317► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: AFATINIB DIMALEATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2014005,C1345910Lithuania► SubscribePRODUCT NAME: AFATINIBUM; REGISTRATION NO/DATE: EU/1/13/879/001-EU/1/13/879/012 20130925
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
00643Netherlands► SubscribePRODUCT 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
370Luxembourg► SubscribePRODUCT 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
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

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.

`abc