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Generated: December 14, 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

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 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 022217-001 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
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
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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Supplementary Protection Certificates for ALISKIREN HEMIFUMARATE; VALSARTAN

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90055-0 Sweden ➤ Sign Up PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414
C041/2007 Ireland ➤ Sign Up SPC041/2007: 20080416, EXPIRES: 20200406
0678503/01 Switzerland ➤ Sign Up PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
2012 00018 Denmark ➤ Sign Up PRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
13/058 Ireland ➤ Sign Up 2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Cipla
Johnson and Johnson
Chinese Patent Office
QuintilesIMS
Boehringer Ingelheim
Fuji
Healthtrust
McKinsey
Merck

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