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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 freedom to operate?

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.

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide has one hundred and eighty-three patent family members in thirty-five countries.

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

Summary for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

International Patents:	183
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	200045-003	Dec 21, 2010		DISCN	No	No			Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010		DISCN	No	No			Y	Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010		DISCN	No	No			Y	Y
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	200045-001	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	200045-003	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 Africa	200408442
European Patent Office	0678514
Russian Federation	2310443
Japan	H0827079
Canada	2147044

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503/04	Switzerland		PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
00625	Netherlands		PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
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
2012 00018	Denmark		PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
90055-0	Sweden		PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414