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Dow
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Argus Health
Federal Trade Commission
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Generated: April 26, 2018

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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-one patent family members in thirty-five countries.

There are four drug master file entries for aliskiren hemifumarate; valsartan.
Summary for aliskiren hemifumarate; valsartan
International Patents:151
US Patents:2
Tradenames:1
Applicants:1
NDAs:1
Drug Master File Entries: 4
Clinical Trials: 398
Drug Prices:see low prices
DailyMed Link:aliskiren hemifumarate; valsartan at DailyMed

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 022217-002 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 ➤ 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
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-001 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 022217-002 Sep 16, 2009 ➤ Sign Up ➤ Sign Up
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-001 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
9,023,894 Synergistic combinations comprising a renin inhibitor for cardiovascular diseases ➤ Sign Up
8,618,174 Synergistic combinations comprising a renin inhibitor for cardiovascular diseases ➤ 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
C0055 France ➤ Sign Up PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
0678503/01 Switzerland ➤ Sign Up PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
13/058 Ireland ➤ Sign Up 2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
/2009 Austria ➤ Sign Up PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
US Army
Fuji
Chubb
Accenture
Baxter
Cerilliant
Julphar

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