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Last Updated: September 25, 2023

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 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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide has thirty-two patent family members in twenty-four countries.

Summary for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

International Patents:	32
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
DailyMed Link:	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide at DailyMed

Anatomical Therapeutic Chemical (ATC) Classes for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

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

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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	200045-004	Dec 21, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-002	Dec 21, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010		DISCN	No	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-005	Dec 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-001	Dec 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010	⤷ Try a Trial	⤷ Try a Trial
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	Dec 21, 2010	⤷ Try a Trial	⤷ Try a Trial
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

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Country	Patent Number	Title	Estimated Expiration
South Korea	20130109244	PHARMACEUTICAL COMPOSITION COMPRISING A RENIN INHIBITOR, A CALCIUM CHANNEL BLOCKER AND A DIURETIC	⤷ Try a Trial
Luxembourg	92000		⤷ Try a Trial
Denmark	1507558		⤷ Try a Trial
Brazil	0310084	Composição farmacêutica compreendendo um inibidor de renina, um bloqueador de canal de cálcio e um diurético	⤷ Try a Trial
Portugal	1507558		⤷ Try a Trial
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1507558	C20120009 00055	Estonia	⤷ Try a Trial	PRODUCT NAME: RASITRIO - ALISKIREEN/AMLODIPIIN/HUEDROKLOROTIASIID;REG NO/DATE: C(2011)8695 FINAL 22.11.2011
1507558	12C0033	France	⤷ Try a Trial	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: CH - 6167801 20110705
1915993	122013000093	Germany	⤷ Try a Trial	PRODUCT NAME: KOMBINATION UMFASSEND ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/686/001 - 056 20110414
2305232	122019000098	Germany	⤷ Try a Trial	PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116
1602370	SPC/GB09/024	United Kingdom	⤷ Try a Trial	PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description

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