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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Boehringer Ingelheim
Farmers Insurance
Accenture
Daiichi Sankyo
US Army
Fish and Richardson
Healthtrust
Medtronic

Generated: July 17, 2018

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 fifty-one patent family members in thirty-five countries.

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

US Patents and Regulatory Information 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;ORAL 022217-001 Sep 16, 2009 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-001 Sep 16, 2009 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-002 Sep 16, 2009 DISCN No No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-002 Sep 16, 2009 DISCN No No ➤ Sign Up ➤ Sign Up Y Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for aliskiren hemifumarate; valsartan

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-001 Sep 16, 2009 ➤ Sign Up ➤ Sign Up
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-002 Sep 16, 2009 ➤ Sign Up ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Non-Orange Book US Patents for 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 ➤ Sign Up
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Sign Up
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Sign Up
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for aliskiren hemifumarate; valsartan

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2009 00010 Denmark ➤ Sign Up PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028
3 5008-2012 Slovakia ➤ Sign Up PRODUCT 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
90018-9 Sweden ➤ Sign Up PRODUCT 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
C0063 France ➤ Sign Up PRODUCT 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Boehringer Ingelheim
Teva
Accenture
Johnson and Johnson
Express Scripts
Citi
Chinese Patent Office
Chubb
US Department of Justice

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.