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VALTURNA Drug Profile

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Which patents cover Valturna, and what substitute generic drugs are available?

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

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

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

Summary for Tradename: VALTURNA

Patents:2
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:VALTURNA at DailyMed
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-001Sep 16, 2009DISCNNoNo5,559,111► SubscribeYY ► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 2009DISCNNoNo8,168,616► SubscribeY ► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-001Sep 16, 2009DISCNNoNo8,168,616► SubscribeY ► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 2009DISCNNoNo5,559,111► SubscribeYY ► Subscribe
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Expired Patents for Tradename: VALTURNA

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-001Sep 16, 20095,399,578► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 20095,399,578► Subscribe
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Non-Orange Book Patents for Tradename: VALTURNA

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
9,023,894Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
9,023,893Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► 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 Tradename: VALTURNA

Country Document Number Estimated Expiration
China101264072► Subscribe
New Zealand537691► Subscribe
World Intellectual Property Organization (WIPO)0240007► Subscribe
Norway2007011► Subscribe
Hungary9501077► 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: VALTURNA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
0678503/01Switzerland► SubscribePRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
373Luxembourg► Subscribe91373, EXPIRES: 20200407
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
00528Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
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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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