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Details for Patent: 8,703,781

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

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

This patent has twenty-two patent family members in nineteen 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	Patent Submitted
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No			Y	Y		IMPROVEMENT OF GLYCEMIC CONTROL IN TYPE 2 DIABETES PATIENTS BY ADMINISTERING A STARTING DOSE OF 10 MCG FOR 14 DAYS AND INCREASING TO A MAINTENANCE DOSE OF 20 MCG ON DAY 15
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No			Y	Y		TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST.
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No			Y	Y		TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC ANAPLASTIC THYROID CANCER (ATC) WITH BRAF V600E MUTATION AND WITH NO SATISFACTORY LOCOREGIONAL TREATMENT OPTIONS
Novartis Pharms Corp	TAFINLAR	dabrafenib mesylate	CAPSULE;ORAL	202806-001	May 29, 2013		RX	Yes	No			Y	Y		TAFINLAR IS INDICATED, IN COMBINATION WITH TRAMETINIB, FOR THE ADJUVANT TREATMENT OF PATIENTS WITH MELANOMA WITH BRAF V600E OR V600K MUTATIONS, AS DETECTED BY AN FDA-APPROVED TEST, AND INVOLVEMENT OF LYMPH NODE(S), FOLLOWING COMPLETE RESECTION

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

Non-Orange Book US Patents Family Members for Patent 8,703,781

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,952,018	Pharmaceutical combination of MEK inhibitor and B-Raf inhibitors

International Family Members for US Patent 8,703,781

Country	Document Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Costa Rica	20120155
Dominican Republic	P2012000091
European Patent Office	2488033
Eurasian Patent Organization	201290149