.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Analyze global market entry opportunities
  • Identify first generic entrants

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

How our clients use DrugPatentWatch

DrugPatentWatch Database Preview

Aliskiren hemifumarate; valsartan - Generic Drug Details

« Back to Dashboard

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

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 thirty-eight 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 list115
Drug Prices:see low prices
DailyMed Link:aliskiren hemifumarate; valsartan 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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, 20095,399,578► Subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 20095,399,578► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

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
5,705,658 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
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

International Patent Family for Ingredient: aliskiren hemifumarate; valsartan

Country Document Number Estimated Expiration
China1550491► Subscribe
Greece3031997► Subscribe
New Zealand550897► Subscribe
China101264072► Subscribe
Japan2013213061► Subscribe
This preview shows a limited data set
Subscribe for full access, or try a Trial

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.

Export unavailable in trial.
Subscribe for complete access.

Supplementary Protection Certificates for Tradename: ALISKIREN HEMIFUMARATE; VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2007 00049Denmark► Subscribe
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
564Luxembourg► Subscribe91564, EXPIRES: 20200407
0678503/04Switzerland► SubscribePRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
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
This preview shows a limited data set
Subscribe for full access, or try a Trial

Export unavailable in trial.
Subscribe for complete access.

« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How our clients use DrugPatentWatch

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.

`abc