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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 is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; valsartan has eighty-eight patent family members in thirty-one 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 ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-002 Sep 16, 2009 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
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 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-002 Sep 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-001 Sep 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Novartis VALTURNA aliskiren hemifumarate; valsartan TABLET;ORAL 022217-001 Sep 16, 2009 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; VALSARTAN

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 C01507558/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011
1915993 92315 Luxembourg ➤ Try a Free Trial PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
0678503 C00678503/01 Switzerland ➤ Try a Free Trial PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
1507558 2012/018 Ireland ➤ Try a Free Trial PRODUCT 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
1602370 91563 Luxembourg ➤ Try a Free Trial 91563, EXPIRES: 20231028
1602370 SPC/GB09/024 United Kingdom ➤ Try a Free Trial PRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
1915993 13C0063 France ➤ Try a Free Trial 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
Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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