Details for Patent: 8,703,781

Which drugs does patent 8,703,781 protect, and when does it expire?

Patent 8,703,781 protects MEKINIST and TAFINLAR and is included in four NDAs.

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

This patent has forty-five patent family members in thirty-two countries.

Summary for Patent: 8,703,781

Title:	Pharmaceutical combination of MEK inhibitor and B-RAF inhibitors
Abstract:	A novel combination comprising the MEK inhibitor N-{3-[3-cyclopropyl-5-(2-fluoro-4-iodo-phenylamino)6,8-dimethyl;-2,4,7-tr- ioxo-3,4,6,7-tetrahydro-2H-pyrido[4,3-d]pyrimidin-1-yl]phenyl}acetamide, or a pharmaceutically acceptable salt or solvate thereof, with a B-Raf inhibitor, particularly N-{3-[5-(2-Amino-4-pyrimidinyl)-2-(1,1-dimethylethyl)-1,3-thiazol-4-yl]-2- -fluorophen-}-2,6-difluorobenzenesulfonamide or a pharmaceutically acceptable salt thereof, pharmaceutical compositions comprising the same and methods of using such combinations and compositions in the treatment of conditions in which the inhibition of MEK and/or B-Raf is beneficial, eg. cancer.
Inventor(s):	Dumble; Melissa (Collegeville, PA), Kumar; Rakesh (Collegeville, PA), Laquerre; Sylvie (Collegeville, PA), Lebowitz; Peter (Collegeville, PA)
Assignee:	GlaxoSmithKline LLC (Philadelphia, PA)
Application Number:	13/499,779
Patent Claim Types: see list of patent claims	Compound; Composition; Device; Use;

Drugs Protected by US Patent 8,703,781

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Novartis	MEKINIST	trametinib dimethyl sulfoxide	SOLUTION;ORAL	217513-001	Mar 16, 2023		RX	Yes	Yes			Y	Y		MEKINIST IS INDICATED, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 YEAR OF AGE AND OLDER WITH LOW-GRADE GLIOMA (LGG) WITH A BRAF V600E MUTATION WHO REQUIRE SYSTEMIC THERAPY
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No					Y
Novartis	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-002	May 29, 2013		RX	Yes	Yes					Y

Foreign Priority and PCT Information for Patent: 8,703,781

PCT Information
PCT Filed	October 15, 2010	PCT Application Number:	PCT/US2010/052808
PCT Publication Date:	April 21, 2011	PCT Publication Number:	WO2011/047238

International Family Members for US Patent 8,703,781

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Australia	2010306653
Brazil	112012008854
Canada	2775803