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Serving 500+ biopharmaceutical companies globally:

Federal Trade Commission
Queensland Health
US Army
Johnson and Johnson
Fish and Richardson

Generated: June 27, 2017

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201292

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NDA 201292 describes GILOTRIF, which is a drug marketed by Boehringer Ingelheim and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the GILOTRIF profile page.

The generic ingredient in GILOTRIF is afatinib dimaleate. There are three drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the afatinib dimaleate profile page.

Summary for NDA: 201292


Pharmacology for NDA: 201292

Mechanism of ActionProtein Kinase Inhibitors

Suppliers and Packaging for NDA: 201292

Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
afatinib dimaleate
TABLET;ORAL 201292 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0137 0597-0137-30 1 BOTTLE in 1 CARTON (0597-0137-30) > 30 TABLET, FILM COATED in 1 BOTTLE
afatinib dimaleate
TABLET;ORAL 201292 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0138 0597-0138-30 1 BOTTLE in 1 CARTON (0597-0138-30) > 30 TABLET, FILM COATED in 1 BOTTLE

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 12, 2013TE:RLD:Yes
Patent:8,426,586Patent Expiration:Oct 10, 2029Product Flag?Substance Flag?YDelist Request?
Patent:8,545,884Patent Expiration:Dec 19, 2029Product Flag?YSubstance Flag?Delist Request?
Patent:9,539,258Patent Expiration:Nov 9, 2026Product Flag?Substance Flag?Delist Request?

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Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
Harvard Business School
Queensland Health
US Army

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