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AMTURNIDE Drug Profile

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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 sixty-six patent family members in thirty-five 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 Tradename: AMTURNIDE

Patents:3
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices:see details
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-001Dec 21, 2010DISCNNo5,559,111► subscribeYY ► subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-003Dec 21, 2010DISCNNo5,559,111► subscribeYY ► subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-002Dec 21, 2010DISCNNo5,559,111► subscribeYY ► 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
5,659,065 Alpha-aminoalkanoic acids and reduction products► subscribe
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► subscribe
9,023,893Synergistic combinations comprising a renin inhibitor for cardiovascular diseases► 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
Luxembourg92000► subscribe
European Patent Office1930000► subscribe
Poland361404► 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
00625Netherlands► subscribePRODUCT 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
0296Netherlands► subscribe300296, 20150407, EXPIRES: 20200406
315Luxembourg► subscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
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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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