Details for Patent: 8,545,884

Which drugs does patent 8,545,884 protect, and when does it expire?

Patent 8,545,884 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 thirty-nine patent family members in thirty-five countries.

Summary for Patent: 8,545,884

Title:	Solid pharmaceutical formulations comprising BIBW 2992
Abstract:	The present invention relates to a pharmaceutical dosage form containing the active substance BIBW 2992 as the dimaleate salt, providing an immediate release profile of the active substance, further, the invention relates to compacted intermediates comprising BIBW 2992 dimaleate salt (BIBW 2992 MA2) in form of a powder prepared using a combined roller compaction and sieving step from BIBW 2992 MA2, intermediate blends prepared from said compacted intermediate as well as solid oral formulations providing an immediate release profile of the active substance, made from said compacted intermediate or from said intermediate blends ready for use/ingestion, e.g. capsule and tablet formulations such as uncoated or film-coated tablets prepared by direct-compression, and methods for their production.
Inventor(s):	Roman Messerschmid, Thomas Friedl
Assignee:	Boehringer Ingelheim International GmbH
Application Number:	US12/995,715
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,545,884
Patent Claim Types: see list of patent claims	Use; Composition; Formulation; Dosage form;

Drugs Protected by US Patent 8,545,884

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	AB	RX	Yes	No	8,545,884*PED				Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-002	Jul 12, 2013	AB	RX	Yes	No	8,545,884*PED				Y
Boehringer Ingelheim	GILOTRIF	afatinib dimaleate	TABLET;ORAL	201292-003	Jul 12, 2013	AB	RX	Yes	Yes	8,545,884*PED				Y

Foreign Priority and PCT Information for Patent: 8,545,884

Foriegn Application Priority Data
Foreign Country	Foreign Patent Number	Foreign Patent Date
	08157800	Jun 6, 2008
	09160297	May 14, 2009

PCT Information
PCT Filed	June 05, 2009	PCT Application Number:	PCT/EP2009/056944
PCT Publication Date:	December 10, 2009	PCT Publication Number:	WO2009/147238

International Family Members for US Patent 8,545,884

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	072062
Australia	2009254574
Brazil	PI0913379
Canada	2726472
Chile	2010001275
China	102056589