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Aliskiren hemifumarate; amlodipine besylate - Generic Drug Details

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Aliskiren hemifumarate; amlodipine besylate is the generic ingredient in two branded drugs marketed by Novartis and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

This ingredient has eighty-seven patent family members in thirty-four countries.

There are four drug master file entries for aliskiren hemifumarate; amlodipine besylate.

Summary for Generic Name: aliskiren hemifumarate; amlodipine besylate

Tradenames:2
Patents:4
Applicants:1
NDAs:2
Drug Master File Entries: see list4
Formulation / Manufacturing:see details
Drug Prices:see low prices
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, 2010DISCNNo8,618,174► subscribeY ► subscribe
Novartis
AMTURNIDE
aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide
TABLET;ORAL200045-002Dec 21, 2010DISCNNo8,183,295► subscribeY ► subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-004Aug 26, 2010DISCNNo8,613,949► subscribeY ► subscribe
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Non-Orange Book Patents for Generic Ingredient: aliskiren hemifumarate; amlodipine besylate

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
5,705,658 Azido containing tetrahydro furan compounds► subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► subscribe
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► 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 Ingredient: aliskiren hemifumarate; amlodipine besylate

Country Document Number Estimated Expiration
Malaysia119161► subscribe
European Patent Office0678503► subscribe
Hong Kong1070881► 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: ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0678503/04Switzerland► subscribePRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
2012000031Germany► subscribePRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705
13/058Ireland► subscribePRODUCT NAME: COMBINATION COMPRISING ALISKIREN, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF, AND AMLODIPINE, OR A PHARMACEUTICAL ACCEPTABLE SALT THEREOF.; REGISTRATION NO/DATE: EU/1/11/686/001-EU/1/11/686/056 20110414
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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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