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Serving leading biopharmaceutical companies globally:

Merck
Healthtrust
Boehringer Ingelheim
Mallinckrodt
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AstraZeneca
Cipla
Federal Trade Commission
Deloitte
Moodys

Generated: November 25, 2017

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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 fifty patent family members in thirty-five countries and thirty-nine supplementary protection certificates in eleven countries.

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

Summary for aliskiren hemifumarate; valsartan

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► SubscribeYY ► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 2009DISCNNoNo► Subscribe► SubscribeY ► 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
5,606,078 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
9,023,893Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► 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
5,646,143 .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; valsartan

Country Document Number Estimated Expiration
Hungary0301841► Subscribe
Spain2308347► Subscribe
Luxembourg92315► Subscribe
Israel212075► Subscribe
New Zealand270938► Subscribe
New Zealand550897► Subscribe
Greece3031997► Subscribe
Norway2007011► Subscribe
China1266118► Subscribe
Spain2429292► 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
3 5008-2012Slovakia► SubscribePRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705
13/058Ireland► Subscribe2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
0678503/02Switzerland► SubscribePRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
90055-0Sweden► SubscribePRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414
373Luxembourg► Subscribe91373, EXPIRES: 20200407
0296Netherlands► Subscribe300296, 20150407, EXPIRES: 20200406
563Luxembourg► Subscribe91563, EXPIRES: 20231028
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
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
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Farmers Insurance
Chubb
McKesson
Novartis
Teva
QuintilesIMS
Queensland Health
Mallinckrodt
US Department of Justice
Federal Trade Commission

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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