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Generated: December 14, 2017

DrugPatentWatch Database Preview

AMTURNIDE Drug Profile

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Which patents cover Amturnide, and what generic alternatives are available?

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

This drug has one hundred and eighty-two patent family members in thirty-five countries and forty-two supplementary protection certificates in twelve countries.

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

Summary for AMTURNIDE

Drug patent expirations by year for AMTURNIDE

US Patents and Regulatory Information

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Patent Submitted Product Substance Delist Req. Exclusivity Expiration
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-001Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-003Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-002Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-004Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeYY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-003Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-005Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-001Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-001Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeYY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-002Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeYY► Subscribe
NovartisAMTURNIDEaliskiren hemifumarate; amlodipine besylate; hydrochlorothiazideTABLET;ORAL200045-002Dec 21, 2010DISCNNoNo► Subscribe► Subscribe► SubscribeY► Subscribe
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Non-Orange Book Patents for Tradename: AMTURNIDE

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
8,168,616Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension► Subscribe
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► Subscribe
9,023,893Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
9,023,894Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► Subscribe
5,705,658 Azido containing tetrahydro furan compounds► Subscribe
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids► Subscribe
5,659,065 Alpha-aminoalkanoic acids and reduction products► Subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: AMTURNIDE

Country Document Number Estimated Expiration
Poland400915► Subscribe
China1153759► Subscribe
Denmark1915993► Subscribe
South Korea101258365► Subscribe
EcuadorSP045428► Subscribe
Slovakia287881► Subscribe
European Patent Office1507558► Subscribe
Norway951443► Subscribe
Czech Republic9500976► Subscribe
Israel212075► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: AMTURNIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90055-0Sweden► SubscribePRODUCT 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
C041/2007Ireland► SubscribeSPC041/2007: 20080416, EXPIRES: 20200406
0678503/01Switzerland► SubscribePRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
90018-9Sweden► SubscribePRODUCT 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
13/058Ireland► Subscribe2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
C0033France► SubscribePRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: 6167801 20110705
2009 00009Denmark► Subscribe
3 5008-2012Slovakia► SubscribePRODUCT 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
00385Netherlands► SubscribePRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028
C0020France► SubscribePRODUCT NAME: COMBINAISON COMRENANT L’ALISKIREN SOUS FORME DE BAE LIBRE OU UN SEL DE CELUI-CI PHARMACEUTIQUEMENT ACCEPTABLE, ET L’HYDROCHLOROTHIAZIDE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; REGISTRATION NO/DATE IN FRANCE: EU/1/08/491/001 DU 20090116; REGISTRATION NO/DATE AT EEC: 58935 01-04 DU 20081028
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Serving leading biopharmaceutical companies globally:

Covington
Queensland Health
McKinsey
AstraZeneca
Boehringer Ingelheim
McKesson
Chinese Patent Office
Novartis
Citi
Merck

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.

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