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Serving leading biopharmaceutical companies globally:

McKinsey
Dow
Argus Health
Moodys
Cerilliant
Citi
Julphar
Express Scripts
McKesson
UBS

Generated: November 23, 2017

DrugPatentWatch Database Preview

TEKAMLO Drug Profile

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Which patents cover Tekamlo, and when can generic versions of Tekamlo launch?

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

This drug has eighty-eight patent family members in thirty-four countries and thirty-seven supplementary protection certificates in eleven countries.

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

Summary for TEKAMLO

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-001Aug 26, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-004Aug 26, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-002Aug 26, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-004Aug 26, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-001Aug 26, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-002Aug 26, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-003Aug 26, 2010DISCNNoNo► Subscribe► SubscribeY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-003Aug 26, 2010DISCNNoNo► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Tradename: TEKAMLO

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
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► Subscribe
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids► Subscribe
5,659,065 Alpha-aminoalkanoic acids and reduction products► Subscribe
5,705,658 Azido containing tetrahydro furan compounds► 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: TEKAMLO

Country Document Number Estimated Expiration
South Korea20110060942► Subscribe
European Patent Office2328564► Subscribe
Tunisia2011000100► Subscribe
Hungary226860► Subscribe
JapanH0881430► Subscribe
Brazil1100656► Subscribe
Norway2011020► Subscribe
South Africa9503052► Subscribe
Japan3240322► Subscribe
Spain2137478► 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: TEKAMLO

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
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
12/018Ireland► SubscribePRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
00528Netherlands► SubscribePRODUCT NAME: COMBINATIE VAN ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; NATL. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705
564Luxembourg► Subscribe91564, EXPIRES: 20200407
2009 00009Denmark► Subscribe
C/GB09/024United Kingdom► SubscribePRODUCT NAME: COMBINATION COMPRISING ALISKIREN, AS THE FREE BASE OR AS A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF; REGISTERED: CH 5893501 20081028; CH 5893502 20081028; CH 5893503 20081028; CH 5893504 20081028; UK EU/1/08/491/006 20090116; UK EU/1/08/491/002 20090116; UK EU/1/08/491/003 20090116; UK EU/1/08/491/004 20090116; UK EU/1/08/491/005 20090116; UK EU/1/08/491/007 20090116; UK EU/1/08/491/080 20090116; UK EU/1/08/491/074 20090116; UK EU/1/08/491/075 20090116; UK EU/1/08/491/076 20090116; UK EU/1/08/491/077 20090116; UK EU/1/08/491/078 20090116; UK EU/1/08/491/079 20090116; UK EU/1/08/491/068 20090116; UK EU/1/08/4
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
373Luxembourg► Subscribe91373, EXPIRES: 20200407
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For more information try a trial or see the database preview and plans and pricing

Serving leading biopharmaceutical companies globally:

Dow
Daiichi Sankyo
Express Scripts
Cerilliant
Baxter
Farmers Insurance
Covington
Medtronic
Accenture
Novartis

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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