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Serving 500+ biopharmaceutical companies globally:

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Farmers Insurance
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US Army
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Generated: July 26, 2017

DrugPatentWatch Database Preview

Aliskiren hemifumarate; valsartan - Generic Drug Details

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What are the generic sources for aliskiren hemifumarate; valsartan and what is the scope of aliskiren hemifumarate; valsartan freedom to operate?

Aliskiren hemifumarate; valsartan
is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; valsartan has one hundred and forty patent family members in thirty-five countries.

There are four drug master file entries for aliskiren hemifumarate; valsartan.

Summary for Generic Name: aliskiren hemifumarate; valsartan

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list4
Clinical Trials: see list392
Drug Prices:see low prices
DailyMed Link:aliskiren hemifumarate; valsartan at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-001Sep 16, 2009DISCNNoNo► Subscribe► SubscribeYY ► 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
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-001Sep 16, 2009DISCNNoNo► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: aliskiren hemifumarate; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-001Sep 16, 2009► Subscribe► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 2009► Subscribe► Subscribe
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Non-Orange Book Patents for Generic Ingredient: aliskiren hemifumarate; valsartan

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
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
8,618,174Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
9,023,894Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
5,705,658 Azido containing tetrahydro furan compounds► 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; valsartan

Country Document Number Estimated Expiration
Israel212075► Subscribe
European Patent Office2305233► Subscribe
European Patent Office2305231► Subscribe
South Korea100353779► Subscribe
Germany122011100052► 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; VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
00386Netherlands► SubscribePRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028
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
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
2009 00009Denmark► Subscribe
C/GB09/024United Kingdom► SubscribePRODUCT 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
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Colorcon
Queensland Health
US Department of Justice
Healthtrust
Farmers Insurance
Merck
Fish and Richardson
Baxter
Teva
Deloitte

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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