Details for Patent: 10,004,743

Which drugs does patent 10,004,743 protect, and when does it expire?

Patent 10,004,743 protects GILOTRIF and is included in one NDA.

Protection for GILOTRIF has been extended six months for pediatric studies, as indicated by the *PED designation in the table below.

This patent has thirteen patent family members in twelve countries.

Summary for Patent: 10,004,743

Title:	Process for drying of BIBW2992, of its salts and of solid pharmaceutical formulations comprising this active ingredient
Abstract:	The present invention relates to a drying process of BIBW 2992 or the salts thereof, preferably the dimaleate salt, as well as of solid pharmaceutical formulations comprising BIBW2992 or a salt thereof, and to pharmaceutical compositions comprising BIBW 2992 or a salt thereof as the active product ingredient, characterized by a water activity of the formulation of not more than 0.20 or a water content (Karl-Fischer) of not more than 4.2%.
Inventor(s):	Albert BARTA
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US15/371,252
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 10,004,743
Patent Claim Types: see list of patent claims	Composition; Formulation; Dosage form;

Drugs Protected by US Patent 10,004,743

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-001	Jul 12, 2013		RX	Yes	No	10,004,743*PED				Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013		RX	Yes	No	10,004,743*PED				Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013		RX	Yes	Yes	10,004,743*PED				Y

International Family Members for US Patent 10,004,743

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Cyprus	1121782
Denmark	2451445
European Patent Office	2451445
Spain	2731901
Croatia	P20191005
Hungary	E044629
Japan	2012532180