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Aliskiren hemifumarate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for aliskiren hemifumarate?

Aliskiren hemifumarate is the generic ingredient in five branded drugs marketed by Noden Pharma and Novartis, and is included in five NDAs. There are seven patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate has one hundred and one patent family members in thirty-two countries.

There are four drug master file entries for aliskiren hemifumarate. Four suppliers are listed for this compound.

Summary for Generic Name: aliskiren hemifumarate

Tradenames:5
Patents:7
Applicants:2
NDAs:5
Drug Master File Entries: see list4
Suppliers / Packagers: see list4
Bulk Api Vendors: see list74
Clinical Trials: see list55
Patent Applications: see list1,011
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:aliskiren hemifumarate at DailyMed

Pharmacology for Ingredient: aliskiren hemifumarate

Drug ClassRenin Inhibitor
Mechanism of ActionRenin Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-002Jan 18, 2008RXYesNo5,559,111► SubscribeYY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-005Dec 21, 2010DISCNNoNo8,618,174► SubscribeY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-001Jan 18, 2008RXYesNo5,559,111► SubscribeYY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-003Dec 21, 2010DISCNNoNo8,618,174► SubscribeY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-004Dec 21, 2010DISCNNoNo8,618,174► SubscribeY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: aliskiren hemifumarate

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
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► Subscribe
5,705,658 Azido containing tetrahydro furan compounds► Subscribe
8,007,824Galenic formulations of organic compounds► Subscribe
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
5,659,065 Alpha-aminoalkanoic acids and reduction products► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: aliskiren hemifumarate

Country Document Number Estimated Expiration
Japan5925607► Subscribe
Finland951771► Subscribe
BrazilPI0508833► Subscribe
Japan2012211152► Subscribe
Australia2005224010► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: ALISKIREN HEMIFUMARATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90018-9Sweden► SubscribePRODUCT 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
00296Netherlands► SubscribePRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
12/018Ireland► SubscribePRODUCT 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
C0055France► SubscribePRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
2011 00027Denmark► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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