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Generated: July 27, 2017

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Aliskiren hemifumarate; hydrochlorothiazide - Generic Drug Details

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What are the generic drug sources for aliskiren hemifumarate; hydrochlorothiazide and what is the scope of aliskiren hemifumarate; hydrochlorothiazide freedom to operate?

Aliskiren hemifumarate; hydrochlorothiazide
is the generic ingredient in one branded drug marketed by Noden Pharma and is included in one NDA. There are two patents protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Aliskiren hemifumarate; hydrochlorothiazide has ninety-four patent family members in thirty-five countries.

There are four drug master file entries for aliskiren hemifumarate; hydrochlorothiazide. Three suppliers are listed for this compound.

Summary for Generic Name: aliskiren hemifumarate; hydrochlorothiazide

Tradenames:1
Patents:2
Applicants:1
NDAs:1
Drug Master File Entries: see list4
Suppliers / Packagers: see list3
Clinical Trials: see list424
Drug Prices:see low prices
DailyMed Link:aliskiren hemifumarate; hydrochlorothiazide at DailyMed

Pharmacology for Ingredient: aliskiren hemifumarate; hydrochlorothiazide

Ingredient-typeThiazides
Drug ClassRenin Inhibitor
Thiazide Diuretic
Mechanism of ActionRenin Inhibitors
Physiological EffectIncreased Diuresis
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 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 HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-004Jan 18, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-003Jan 18, 2008RXYesYes► Subscribe► SubscribeY ► Subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-001Jan 18, 2008RXYesNo► Subscribe► SubscribeYY ► Subscribe
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Non-Orange Book Patents for Generic Ingredient: aliskiren hemifumarate; hydrochlorothiazide

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 Ingredient: aliskiren hemifumarate; hydrochlorothiazide

Country Document Number Estimated Expiration
Norway951442► Subscribe
BrazilPI0713338► Subscribe
HungaryT74074► Subscribe
South Africa9503051► Subscribe
Norway20090262► 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; HYDROCHLOROTHIAZIDE

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
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
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
564Luxembourg► Subscribe91564, EXPIRES: 20200407
2011 00027Denmark► Subscribe
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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
Deloitte
Baxter
Harvard Business School
Moodys
Medtronic
Merck
Dow
Chubb
Teva

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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