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

Serving hundreds of leading biopharmaceutical companies globally:

McKesson
Mallinckrodt
Covington
US Department of Justice
Daiichi Sankyo
Federal Trade Commission
Dow
Boehringer Ingelheim
McKinsey

Generated: June 23, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201292

« Back to Dashboard

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 and one Paragraph IV challenge. Additional details are available on the GILOTRIF profile page.

The generic ingredient in GILOTRIF is afatinib dimaleate. There are six 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 201292
Tradename:GILOTRIF
Applicant:Boehringer Ingelheim
Ingredient:afatinib dimaleate
Patents:5
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 N 0597-0137-30
GILOTRIF afatinib dimaleate TABLET;ORAL 201292 NDA Boehringer Ingelheim Pharmaceuticals, Inc. 0597-0138 N 0597-0138-30

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 12, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jul 12, 2020
Regulatory Exclusivity Use:FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER (NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST.
Regulatory Exclusivity Expiration:Jul 12, 2018
Regulatory Exclusivity Use:NEW CHEMICAL ENTITY
Regulatory Exclusivity Expiration:Jan 12, 2021
Regulatory Exclusivity Use:TREATMENT OF PATIENTS WITH METASTATIC NON-SMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR RECEPTOR MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST

Complete Access Available with Subscription

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

Serving hundreds of leading biopharmaceutical companies globally:

Baxter
Accenture
Merck
Healthtrust
Colorcon
Mallinckrodt
Dow
Farmers Insurance
US Department of Justice

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.