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Julphar
Queensland Health
Chinese Patent Office
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Express Scripts
Covington
UBS
Cipla
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Generated: October 17, 2018

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VALTURNA Drug Profile

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When do Valturna patents expire, and when can generic versions of Valturna launch?

Valturna is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug.

The generic ingredient in VALTURNA is aliskiren hemifumarate; valsartan. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; valsartan profile page.

Drug patent expirations by year for VALTURNA
Generic Entry Opportunity Date for VALTURNA
Generic Entry Date for VALTURNA*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

US Patents and Regulatory Information for VALTURNA

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 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 022217-002 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 VALTURNA

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
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 VALTURNA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
13/058 Ireland ➤ Sign Up 2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
00385 Netherlands ➤ Sign Up PRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028
564 Luxembourg ➤ Sign Up 91564, EXPIRES: 20200407
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
00499 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
0678503/02 Switzerland ➤ Sign Up PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
00625 Netherlands ➤ Sign Up PRODUCT NAME: COMBINATIE BEVATTENDE ALISKIREN, OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE, OF EEN FARMACEUATISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110414
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Queensland Health
Chinese Patent Office
Federal Trade Commission
Express Scripts
Covington
UBS
Cipla
US Department of Justice

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