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Aliskiren hemifumarate; hydrochlorothiazide - Generic Drug Details

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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.

This ingredient has ninety-four patent family members in thirty-five countries.

There are four drug master file entries for aliskiren hemifumarate; hydrochlorothiazide. Two 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 / Packaging: see list2
Formulation / Manufacturing:see details
Drug Prices:see low prices

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 Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-004Jan 18, 2008RXYes8,618,172► subscribeY ► subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-003Jan 18, 2008RXYes8,618,172► subscribeY ► subscribe
Noden Pharma
TEKTURNA HCT
aliskiren hemifumarate; hydrochlorothiazide
TABLET;ORAL022107-001Jan 18, 2008RXNo8,618,172► subscribeY ► 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
5,627,182 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides► subscribe
5,646,143 .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 Ingredient: aliskiren hemifumarate; hydrochlorothiazide

Country Document Number Estimated Expiration
Norway20090262► subscribe
Norway2009011► subscribe
Netherlands300386► 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
1507558/01Switzerland► subscribePRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011
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
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
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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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