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Serving 500+ biopharmaceutical companies globally:

Moodys
Fish and Richardson
Dow
Federal Trade Commission
Mallinckrodt
Teva
Fuji
McKinsey
Cipla
Queensland Health

Generated: July 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-seven patent family members in thirty-four 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 Tradename: TEKAMLO

Patents:2
Applicants:1
NDAs:1
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TEKAMLO at DailyMed
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, 2010DISCNNoNo8,613,949► SubscribeY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-004Aug 26, 2010DISCNNoNo8,613,949► SubscribeY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-002Aug 26, 2010DISCNNoNo5,559,111► SubscribeYY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-004Aug 26, 2010DISCNNoNo5,559,111► SubscribeYY ► Subscribe
Novartis
TEKAMLO
aliskiren hemifumarate; amlodipine besylate
TABLET;ORAL022545-001Aug 26, 2010DISCNNoNo5,559,111► 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
5,659,065 Alpha-aminoalkanoic acids and reduction products► Subscribe
5,705,658 Azido containing tetrahydro furan compounds► Subscribe
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► Subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids► 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
Denmark0678503► Subscribe
Israel113402► Subscribe
Canada2736257► Subscribe
South Korea20110060942► Subscribe
Colombia6351711► 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
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
373Luxembourg► Subscribe91373, EXPIRES: 20200407
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
C/GB07/060United Kingdom► SubscribePRODUCT NAME: ALISKIREN OR PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; REGISTERED: UK EU/1/04/405/001 20070822; UK EU/1/04/405/002 20070822; UK EU/1/04/405/003 20070822; UK EU/1/04/405/004 20070822; UK EU/1/04/405/005 20070822; UK EU/1/04/405/006 20070822; UK EU/1/04/405/007 20070822; UK EU/1/04/405/008 20070822; UK EU/1/04/405/009 20070822; UK EU/1/04/405/010 20070822; UK EU/1/04/405/011 20070822; UK EU/1/04/405/012 20070822; UK EU/1/04/405/013 20070822; UK EU/1/04/405/014 20070822; UK EU/1/04/405/015 20070822; UK EU/1/04/405/016 20070822; UK EU/1/04/405/017 20070822; UK EU/1/04/405/018 20070822; UK EU/1/04/405/019 20070822; UK EU/1/04/405/020 20070822
2013 00062Denmark► SubscribePRODUCT NAME: KOMBINATION OMFATTENDE ALISKIREN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER HEMIFUMARAT, OG AMLODIPIN, ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, HERUNDER BENSYLAT; REG. NO/DATE: EU/1/11/686/001/056 20110418
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Queensland Health
Argus Health
Baxter
Covington
Fuji
QuintilesIMS
Daiichi Sankyo
Mallinckrodt
Federal Trade Commission
Johnson and Johnson

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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