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Serving leading biopharmaceutical companies globally:

Merck
Federal Trade Commission
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Healthtrust
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US Army
Fuji
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Generated: November 22, 2017

DrugPatentWatch Database Preview

Aliskiren hemifumarate - Generic Drug Details

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

Aliskiren hemifumarate
is the generic ingredient in five branded drugs marketed by Noden Pharma and Novartis, and is included in five NDAs. There are nine 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 four patent family members in thirty-three countries and thirty-seven supplementary protection certificates in eleven countries.

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

Pharmacology for aliskiren hemifumarate

Drug ClassRenin Inhibitor
Mechanism of ActionRenin Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-003Aug 26, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 2009DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-003Aug 26, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-001Aug 26, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-002Aug 26, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Noden Pharma
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL021985-001Mar 5, 2007RXYesNo► Subscribe► SubscribeY► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-003Dec 21, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-004Dec 21, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Noden Pharma
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL021985-002Mar 5, 2007RXYesYes► Subscribe► 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
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids► Subscribe
5,659,065 Alpha-aminoalkanoic acids and reduction products► Subscribe
8,007,824Galenic formulations of organic compounds► Subscribe
7,683,054Galenic formulations of organic compounds► Subscribe
5,705,658 Azido containing tetrahydro furan compounds► Subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► 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
HungaryT74074► Subscribe
South Africa9503052► Subscribe
Austria183997► Subscribe
South Korea20130028803► Subscribe
Australia1642195► Subscribe
Netherlands300296► Subscribe
Hungary9501076► Subscribe
JapanH0827079► Subscribe
Norway2009011► Subscribe
Israel113403► 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
C0063France► SubscribePRODUCT 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
2013000093Germany► SubscribePRODUCT 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
00625Netherlands► SubscribePRODUCT 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
315Luxembourg► SubscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
00385Netherlands► SubscribePRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028
C/GB07/060United Kingdom► SubscribePRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822
00499Netherlands► SubscribePRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
C0020France► SubscribePRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
/2009Austria► SubscribePRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028
00296Netherlands► SubscribePRODUCT NAME: ALISKIREN OF EEN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
UBS
McKesson
Fuji
US Department of Justice
Mallinckrodt
Chubb
Fish and Richardson
Novartis
Express Scripts

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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