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Serving 500+ biopharmaceutical companies globally:

Deloitte
Novartis
Chubb
Cipla
Daiichi Sankyo
Farmers Insurance
Mallinckrodt
Fish and Richardson
Citi
Queensland Health

Generated: July 24, 2017

DrugPatentWatch Database Preview

TEKTURNA Drug Profile

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What is the patent landscape for Tekturna, and when can generic versions of Tekturna launch?

Tekturna is a drug marketed by Noden Pharma and is included in two NDAs. There are three patents protecting this drug and two Paragraph IV challenges.

This drug has one hundred and two patent family members in thirty-two countries.

The generic ingredient in TEKTURNA is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.

Summary for Tradename: TEKTURNA

Patents:2
Applicants:1
NDAs:2
Suppliers / Packagers: see list4
Bulk Api Vendors: see list37
Clinical Trials: see list17
Patent Applications: see list794
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TEKTURNA at DailyMed

Pharmacology for Tradename: TEKTURNA

Drug ClassRenin Inhibitor
Mechanism of ActionRenin Inhibitors
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noden Pharma
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL021985-001Mar 5, 2007RXYesNo► Subscribe► SubscribeY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-002Jan 18, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Noden Pharma
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL021985-002Mar 5, 2007RXYesYes► Subscribe► SubscribeYY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-004Jan 18, 2008RXYesYes► Subscribe► SubscribeYY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-002Jan 18, 2008RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Paragraph IV activity for: TEKTURNA

Drugname Dosage Strength RLD Submissiondate
aliskiren hemifumarate and hydrochlorothiazideTablets150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mgTekturna HCT3/7/2014
aliskiren hemifumarateTablets150 mg and 300 mgTekturna12/13/2013

Non-Orange Book Patents for Tradename: TEKTURNA

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
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► Subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
5,659,065 Alpha-aminoalkanoic acids and reduction products► 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: TEKTURNA

Country Document Number Estimated Expiration
New Zealand548823► Subscribe
Norway310410► Subscribe
Germany122011100052► Subscribe
Norway2009011► Subscribe
Peru00752006► 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: TEKTURNA

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0678503/02Switzerland► SubscribePRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
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
1507558/01Switzerland► SubscribePRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011
2013000093Germany► SubscribePRODUCT NAME: KOMBINATION UMFASSEND ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON UND AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; REGISTRATION NO/DATE: EU/1/11/686/001 - 056 20110414
2012 00018Denmark► SubscribePRODUCT NAME: ALISKIREN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF, AMLODIPIN ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF OG HYDROCHLORTHIAZID ELLER ET FARMACEUTISK ACCEPTABELT SALT DERAF; NAT. REG. NO/DATE: EU/1/11/730/001-060 20111122; FIRST REG. NO/DATE: CH 61678 01-05 20110705
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Citi
UBS
QuintilesIMS
Julphar
Fuji
Harvard Business School
Daiichi Sankyo
AstraZeneca
Cerilliant
Baxter

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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