Details for Patent: 8,613,949

Which drugs does patent 8,613,949 protect, and when does it expire?

Patent 8,613,949 protects TEKAMLO and is included in one NDA.

This patent has twenty-three patent family members in twenty-one countries.

Summary for Patent: 8,613,949

Title:	Galenical formulations of organic compounds
Abstract:	The present invention relates to a pharmaceutical oral fixed dose combination comprising a) a therapeutically effective amount of Aliskiren, or a pharmaceutically acceptable salt thereof, b) a therapeutically effective amount of Amlodipine, or a pharmaceutically acceptable salt thereof, wherein the pharmaceutical oral fixed dose combination shows an in vitro dissolution of component (a) of 60% or less after 10 minutes and 98% or less after 20 minutes, and a dissolution profile of component (b) of 50% or more after 20 minutes, and 70% or more after 30 minutes at pH 2, said pharmaceutical oral fixed dose combination being bioequivalent, or close to reaching bioequivalence, to a free dose combination of Aliskiren and Amlodipine.
Inventor(s):	Valazza; Stephen (Matawan, NJ), Wagner; Robert F (Hillsborough, NJ), Vippagunta; Sudha (Morris Plains, NJ)
Assignee:	Novartis AG (Basel, CH)
Application Number:	13/063,955
Patent Claim Types: see list of patent claims	Composition; Formulation; Compound; Dosage form; Use;

Drugs Protected by US Patent 8,613,949

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	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-001	Aug 26, 2010		DISCN	No	No			Y
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-002	Aug 26, 2010		DISCN	No	No			Y
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-003	Aug 26, 2010		DISCN	No	No			Y
Novartis	TEKAMLO	aliskiren hemifumarate; amlodipine besylate	TABLET;ORAL	022545-004	Aug 26, 2010		DISCN	No	No			Y

Foreign Priority and PCT Information for Patent: 8,613,949

PCT Information
PCT Filed	September 22, 2009	PCT Application Number:	PCT/US2009/057750
PCT Publication Date:	March 25, 2010	PCT Publication Number:	WO2010/033954

International Family Members for US Patent 8,613,949

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
Argentina	073384
Australia	2009292908
Brazil	PI0919350
Canada	2736257