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Last Updated: April 1, 2026

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 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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for 201292

Generic Entry Date for 201292^: ⤷ Start Trial* Constraining patent/regulatory exclusivity: 8,545,884PED 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 Action	Protein 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

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 20MG BASE
Approval Date:	Jul 12, 2013	TE:		RLD:	Yes
Patent:	10,004,743*PED	Patent Expiration:	Jan 5, 2031	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,426,586*PED	Patent Expiration:	Apr 10, 2030	Product Flag?		Substance Flag?		Delist Request?	Y
Patent:	8,545,884*PED	Patent Expiration:	Jun 19, 2030	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 201292

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013	6,251,912	⤷ Start Trial
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013	6,251,912	⤷ Start Trial
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013	6,251,912	⤷ Start Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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