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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 four patents protecting this drug. Additional details are available on the GILOTRIF profile page.

The generic ingredient in GILOTRIF is afatinib dimaleate. One supplier is listed for this compound. Additional details are available on the afatinib dimaleate profile page.

Summary for NDA: 201292

Tradename:
GILOTRIF
Applicant:
Boehringer Ingelheim
Ingredient:
afatinib dimaleate
Patents:4

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
GILOTRIF
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
GILOTRIF
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:No
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:RE43431Patent Expiration:Jan 22, 2022Product Flag?Substance Flag?YDelist Request?


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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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