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Last Updated: May 14, 2021

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TEKTURNA HCT Drug Profile

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When do Tekturna Hct patents expire, and what generic alternatives are available?

Tekturna Hct is a drug marketed by Noden Pharma and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and twenty-five patent family members in thirty-nine countries.

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

DrugPatentWatch® Generic Entry Outlook for Tekturna Hct

Tekturna Hct was eligible for patent challenges on March 5, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13, 2028. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

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Drug patent expirations by year for TEKTURNA HCT
Drug Prices for TEKTURNA HCT

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DrugPatentWatch® Estimated Generic Entry Opportunity Date for TEKTURNA HCT
Generic Entry Date for TEKTURNA HCT*:
Constraining patent/regulatory exclusivity:
NDA:
Dosage:
TABLET;ORAL

*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for TEKTURNA HCT

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Wayne State UniversityPhase 4
University of Alabama at BirminghamPhase 4
Mayo ClinicN/A

See all TEKTURNA HCT clinical trials

Pharmacology for TEKTURNA HCT
Drug ClassRenin Inhibitor
Thiazide Diuretic
Mechanism of ActionRenin Inhibitors
Physiological EffectIncreased Diuresis
Paragraph IV (Patent) Challenges for TEKTURNA HCT
Tradename Dosage Ingredient NDA Submissiondate
TEKTURNA HCT TABLET;ORAL aliskiren hemifumarate; hydrochlorothiazide 022107 2014-03-07

US Patents and Regulatory Information for TEKTURNA HCT

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;ORAL 022107-001 Jan 18, 2008 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 RX Yes Yes   Get Started for $10   Get Started for $10 Y   Get Started for $10
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 RX Yes No   Get Started for $10   Get Started for $10 Y   Get Started for $10
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for TEKTURNA HCT

Supplementary Protection Certificates for TEKTURNA HCT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 2012/018 Ireland   Get Started for $10 PRODUCT NAME: ALISKIREN OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF, AMLODIPINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF AND HYDROCHLOROTHIAZIDE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF.; NAT REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION NO/DATE: SWITZERLAND 6167801-6167805 20110705
0678503 CA 2009 00009 Denmark   Get Started for $10
0678503 C300386 Netherlands   Get Started for $10 PRODUCT NAME: COMBINATIE OMVATTENDE ALISKIREN, ALS VRIJE BASE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN HYDROCHLOORTHIAZIDE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT ERVAN; NATL. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: CH 58935 01-04 20081028
1915993 C300625 Netherlands   Get Started for $10 PRODUCT 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
0678503 07C0055 France   Get Started for $10 PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
1915993 2013/058 Ireland   Get Started for $10 2013/058 DECLARED INVALID WITH ARTICLE 15 1C OF REGULATION EC NO. 469/2009
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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