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Last Updated: May 29, 2023

TEKTURNA Drug Patent Profile


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Which patents cover Tekturna, and when can generic versions of Tekturna launch?

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

This drug has forty patent family members in twenty-two countries.

The generic ingredient in TEKTURNA 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

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

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
Drug Prices for TEKTURNA

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Recent Clinical Trials for TEKTURNA

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 clinical trials

Pharmacology for TEKTURNA
Drug ClassRenin Inhibitor
Mechanism of ActionRenin Inhibitors
Paragraph IV (Patent) Challenges for TEKTURNA
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TEKTURNA Tablets aliskiren hemifumarate 150 mg and 300 mg 021985 1 2014-01-27

US Patents and Regulatory Information for TEKTURNA

TEKTURNA is protected by one US patents.

Patents protecting TEKTURNA

Galenic formulations of organic compounds
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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 CAPSULE, PELLET;ORAL 210709-001 Nov 14, 2017 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-001 Mar 5, 2007 ⤷  Try a Trial ⤷  Try a Trial
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-002 Mar 5, 2007 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for TEKTURNA

When does loss-of-exclusivity occur for TEKTURNA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Patent: 8431
Estimated Expiration: ⤷  Try a Trial

Australia

Patent: 05224010
Estimated Expiration: ⤷  Try a Trial

Patent: 09202069
Estimated Expiration: ⤷  Try a Trial

Brazil

Patent: 0508833
Estimated Expiration: ⤷  Try a Trial

Canada

Patent: 54633
Estimated Expiration: ⤷  Try a Trial

China

Patent: 97354
Estimated Expiration: ⤷  Try a Trial

Patent: 3462913
Estimated Expiration: ⤷  Try a Trial

Ecuador

Patent: 066807
Estimated Expiration: ⤷  Try a Trial

European Patent Office

Patent: 29736
Estimated Expiration: ⤷  Try a Trial

Patent: 83826
Estimated Expiration: ⤷  Try a Trial

Japan

Patent: 25607
Estimated Expiration: ⤷  Try a Trial

Patent: 07529456
Estimated Expiration: ⤷  Try a Trial

Patent: 12211152
Estimated Expiration: ⤷  Try a Trial

Malaysia

Patent: 4477
Estimated Expiration: ⤷  Try a Trial

Patent: 8773
Estimated Expiration: ⤷  Try a Trial

Mexico

Patent: 7617
Estimated Expiration: ⤷  Try a Trial

Morocco

Patent: 490
Estimated Expiration: ⤷  Try a Trial

New Zealand

Patent: 8823
Estimated Expiration: ⤷  Try a Trial

Norway

Patent: 3217
Estimated Expiration: ⤷  Try a Trial

Patent: 064670
Estimated Expiration: ⤷  Try a Trial

Peru

Patent: 060075
Estimated Expiration: ⤷  Try a Trial

Patent: 110121
Estimated Expiration: ⤷  Try a Trial

Patent: 142101
Estimated Expiration: ⤷  Try a Trial

Russian Federation

Patent: 84328
Estimated Expiration: ⤷  Try a Trial

Patent: 38661
Estimated Expiration: ⤷  Try a Trial

Patent: 80210
Estimated Expiration: ⤷  Try a Trial

Patent: 06136090
Estimated Expiration: ⤷  Try a Trial

Patent: 09138446
Estimated Expiration: ⤷  Try a Trial

Patent: 11135405
Estimated Expiration: ⤷  Try a Trial

Singapore

Patent: 3830
Estimated Expiration: ⤷  Try a Trial

South Africa

Patent: 0606220
Estimated Expiration: ⤷  Try a Trial

South Korea

Patent: 1274855
Estimated Expiration: ⤷  Try a Trial

Patent: 1353736
Estimated Expiration: ⤷  Try a Trial

Patent: 070006776
Estimated Expiration: ⤷  Try a Trial

Patent: 130028803
Estimated Expiration: ⤷  Try a Trial

Spain

Patent: 47941
Estimated Expiration: ⤷  Try a Trial

Taiwan

Patent: 06656
Estimated Expiration: ⤷  Try a Trial

Patent: 0534843
Estimated Expiration: ⤷  Try a Trial

Tunisia

Patent: 06294
Estimated Expiration: ⤷  Try a Trial

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering TEKTURNA around the world.

Country Patent Number Title Estimated Expiration
Czech Republic 287935 Amid delta-amino-gama-hydroxy-omega-arylalkanové kyseliny, způsob jeho přípravy a farmaceutická kompozice tento amid obsahující (Amide of delta-amino-gamma-hydroxy-omega-arylalkanoic acid, process of its preparation and pharmaceutical preparation in which the amide is comprised) ⤷  Try a Trial
Japan 2012211152 GALENIC FORMULATION OF ORGANIC COMPOUND ⤷  Try a Trial
Israel 113402 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEKTURNA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0678503 C00678503/01 Switzerland ⤷  Try a Trial PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
2305232 122019000098 Germany ⤷  Try a Trial PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116
1915993 13C0063 France ⤷  Try a Trial PRODUCT 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Baxter
Medtronic
Johnson and Johnson
Moodys

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 verification 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.