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Generated: September 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
Noden Pharma
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL021985-001Mar 5, 2007RXYesNo► Subscribe► SubscribeYY ► Subscribe
Noden Pharma
TEKTURNA
aliskiren hemifumarate
TABLET;ORAL021985-002Mar 5, 2007RXYesYes► Subscribe► SubscribeY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-001Jan 18, 2008RXYesNo► Subscribe► SubscribeYY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-001Jan 18, 2008RXYesNo► Subscribe► SubscribeY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-003Jan 18, 2008RXYesYes► Subscribe► SubscribeYY ► Subscribe
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Paragraph IV (Patent) Challenges 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
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones► Subscribe
5,659,065 Alpha-aminoalkanoic acids and reduction products► Subscribe
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids► Subscribe
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
8,007,824Galenic formulations of organic compounds► Subscribe
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► Subscribe
7,683,054Galenic formulations of organic compounds► Subscribe
5,705,658 Azido containing tetrahydro furan compounds► 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
Russian Federation95105970► Subscribe
China1266118► Subscribe
South Korea101353736► Subscribe
HungaryT74074► Subscribe
Norway951442► Subscribe
Peru00752006► Subscribe
Netherlands300296► Subscribe
Malaysia148773► Subscribe
European Patent Office0678503► Subscribe
Austria183997► 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
/2009Austria► SubscribePRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028
C0063France► SubscribePRODUCT NAME: COMBINAISON COMPRENANT DE L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET DE L'ALMODIPINE OU L'UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; REGISTRATION NO/DATE: EU/1/11/686/001 20110414
3 5008-2012Slovakia► SubscribePRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705
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
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
315Luxembourg► SubscribePRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
2009 00009Denmark► Subscribe
0625Netherlands► 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
00385Netherlands► SubscribePRODUCT NAME: ALISKIREN, DESGEWENST IN DE VORM; REGISTRATION NO/DATE: 58935 01-04 20081028
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For more information try a trial or see the database preview and plans and pricing

Serving 500+ biopharmaceutical companies globally:

Cantor Fitzgerald
QuintilesIMS
Harvard Business School
US Army
Argus Health
Merck
Healthtrust
Colorcon
AstraZeneca
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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