Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

Get the Book: Make Better Decisions

Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

PDF eBook: Just $10 Get Print Book on Amazon

Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
Merck
AstraZeneca
McKinsey
Dow
Johnson and Johnson

Last Updated: November 13, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 201292

See Plans and Pricing

« 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
Generic Entry Opportunity Date for 201292
Generic Entry Date for 201292*:
Constraining patent/regulatory exclusivity:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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. 0597-0137 0597-0137-90 1 BOTTLE in 1 CARTON (0597-0137-90) > 30 TABLET, FILM COATED in 1 BOTTLE
Paragraph IV (Patent) Challenges for 201292
Tradename Dosage Ingredient NDA Submissiondate
GILOTRIF TABLET;ORAL afatinib dimaleate 201292 2017-07-12

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 20MG BASE
Approval Date:Jul 12, 2013TE:RLD:Yes
Regulatory Exclusivity Expiration:Jan 12, 2025
Regulatory Exclusivity Use:FIRST-LINE TREATMENT OF METASTATIC NONSMALL CELL LUNG CANCER WHOSE TUMORS HAVE NON-RESISTANT EPIDERMAL GROWTH FACTOR MUTATIONS OTHER THAN EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-APPROVED TEST
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: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

Expired US Patents for NDA 201292

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-003 Jul 12, 2013   Start Trial   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-001 Jul 12, 2013   Start Trial   Start Trial
Boehringer Ingelheim GILOTRIF afatinib dimaleate TABLET;ORAL 201292-002 Jul 12, 2013   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Complete Access Available with Subscription

Make Better Decisions: Try a trial or see plans & pricing

Serving leading biopharmaceutical companies globally:

Harvard Business School
Merck
Mallinckrodt
Boehringer Ingelheim
Colorcon
Johnson and Johnson

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.