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Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide - Generic Drug Details

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What are the generic drug sources for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide and what is the scope of aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide patent protection?

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide.

Summary for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

US Patents:	3
Tradenames:	1
Applicants:	1
NDAs:	1
Drug Master File Entries:	4
DailyMed Link:	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide at DailyMed

US Patents and Regulatory Information for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010		DISCN	No	No			Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010		DISCN	No	No			Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010		DISCN	No	No			Y	Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010		DISCN	No	No			Y

Expired US Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010

International Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Country	Document Number	Estimated Expiration
South Korea	100353779
Brazil	1100656
South Korea	20100137026
European Patent Office	2305232

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
00386	Netherlands		PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028
09/010	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/08/491/001-EU/1/08/491/080 20090116; FIRST REGISTRATION NO/DATE: 58935 01 58935 02 58935 03 58935 04 20081028
12/018	Ireland		PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
C0033	France		PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705