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AMTURNIDE Drug Profile

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Which patents cover Amturnide, and what generic alternatives are available?

Amturnide is a drug marketed by Novartis and is included in one NDA. There are three patents protecting this drug.

This drug has one hundred and eighty-three patent family members in thirty-five countries.

The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.

Summary for AMTURNIDE

International Patents:	183
US Patents:	3
Applicants:	1
NDAs:	1
Formulation / Manufacturing:	see details
DailyMed Link:	AMTURNIDE at DailyMed

US Patents and Regulatory Information for AMTURNIDE

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	200045-001	Dec 21, 2010		DISCN	No	No			Y	Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-003	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	Y
Novartis	AMTURNIDE	aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide	TABLET;ORAL	200045-004	Dec 21, 2010		DISCN	No	No			Y

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Non-Orange Book US Patents for AMTURNIDE

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
8,168,616	Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension
5,646,143	.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides
5,606,078	3,5-Disubstituted tetrahydrofuran-2-ones
5,705,658	Azido containing tetrahydro furan compounds

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International Patents for AMTURNIDE

Country	Document Number	Estimated Expiration
Luxembourg	91373
South Africa	200408442
Czech Republic	299749
Germany	122009000021

Supplementary Protection Certificates for AMTURNIDE

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0063	France		PRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414
90018-9	Sweden		PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
00385	Netherlands		PRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028
564	Luxembourg		91564, EXPIRES: 20200407