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Last Updated: May 24, 2022

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-one patent family members in twenty-three 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

See drug prices for TEKTURNA

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

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: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing See Plans and Pricing
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 DISCN Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-001 Mar 5, 2007 AB RX Yes No See Plans and Pricing See Plans and Pricing Y See Plans and Pricing
>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 See Plans and Pricing See Plans and Pricing
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-002 Mar 5, 2007 See Plans and Pricing See Plans and Pricing
>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: See Plans and Pricing

Australia

Patent: 05224010
Estimated Expiration: See Plans and Pricing

Patent: 09202069
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0508833
Estimated Expiration: See Plans and Pricing

Canada

Patent: 54633
Estimated Expiration: See Plans and Pricing

China

Patent: 97354
Estimated Expiration: See Plans and Pricing

Patent: 3462913
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 066807
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 29736
Estimated Expiration: See Plans and Pricing

Patent: 83826
Estimated Expiration: See Plans and Pricing

Israel

Patent: 7424
Estimated Expiration: See Plans and Pricing

Japan

Patent: 25607
Estimated Expiration: See Plans and Pricing

Patent: 07529456
Estimated Expiration: See Plans and Pricing

Patent: 12211152
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 4477
Estimated Expiration: See Plans and Pricing

Patent: 8773
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 7617
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 490
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 8823
Estimated Expiration: See Plans and Pricing

Norway

Patent: 3217
Estimated Expiration: See Plans and Pricing

Patent: 064670
Estimated Expiration: See Plans and Pricing

Peru

Patent: 060075
Estimated Expiration: See Plans and Pricing

Patent: 110121
Estimated Expiration: See Plans and Pricing

Patent: 142101
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 84328
Estimated Expiration: See Plans and Pricing

Patent: 38661
Estimated Expiration: See Plans and Pricing

Patent: 80210
Estimated Expiration: See Plans and Pricing

Patent: 06136090
Estimated Expiration: See Plans and Pricing

Patent: 09138446
Estimated Expiration: See Plans and Pricing

Patent: 11135405
Estimated Expiration: See Plans and Pricing

Singapore

Patent: 3830
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0606220
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1274855
Estimated Expiration: See Plans and Pricing

Patent: 1353736
Estimated Expiration: See Plans and Pricing

Patent: 070006776
Estimated Expiration: See Plans and Pricing

Patent: 130028803
Estimated Expiration: See Plans and Pricing

Spain

Patent: 47941
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 06656
Estimated Expiration: See Plans and Pricing

Patent: 0534843
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 06294
Estimated Expiration: See Plans and Pricing

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
South Korea 20070006776 GALENIC FORMULATIONS OF ORGANIC COMPOUNDS See Plans and Pricing
Malaysia 144477 GALENIC FORMULATIONS OF ORGANIC COMPOUNDS See Plans and Pricing
Japan H0853434 3,5-DISUBSTITUTED TETRAHYDROFURAN-2-ONE See Plans and Pricing
Germany 122011100052 See Plans and Pricing
Denmark 0678503 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEKTURNA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
0678503 C00678503/02 Switzerland See Plans and Pricing PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
0678503 CA 2011 00027 Denmark See Plans and Pricing
1915993 92315 Luxembourg See Plans and Pricing PRODUCT NAME: COMBINAISON COMPRENANT ALISKIREN,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE,ET AMLODIPINE,OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLE
2305232 122019000098 Germany See Plans and Pricing PRODUCT NAME: ALISKIREN HEMIFUMARAT UND HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116
1915993 C300625 Netherlands See Plans and Pricing 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

Merck
AstraZeneca
Baxter
Medtronic
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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.