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Last Updated: May 20, 2022

TEKTURNA HCT Drug Patent Profile


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Which patents cover Tekturna Hct, 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

See drug prices for TEKTURNA HCT

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 Class Renin Inhibitor
Thiazide Diuretic
Mechanism of Action Renin Inhibitors
Physiological EffectIncreased Diuresis
Paragraph IV (Patent) Challenges for TEKTURNA HCT
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
TEKTURNA HCT Tablets aliskiren hemifumarate; hydrochlorothiazide 150 mg/12.5 mg, 150 mg/25 mg 300 mg/12.5 mg 300 mg/25 mg 022107 1 2014-03-07

US Patents and Regulatory Information for TEKTURNA HCT

TEKTURNA HCT is protected by two US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of TEKTURNA HCT is See Plans and Pricing.

This potential generic entry date is based on patent 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.

Patents protecting TEKTURNA HCT

Galenical formulations of organic compounds
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

Synergistic combinations comprising a renin inhibitor for cardiovascular diseases
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 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 022107-004 Jan 18, 2008 RX Yes Yes See Plans and Pricing See Plans and Pricing Y 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 022107-004 Jan 18, 2008 RX Yes Yes 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
>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

International Patents for TEKTURNA HCT

When does loss-of-exclusivity occur for TEKTURNA HCT?

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

Argentina

Patent: 1565
Estimated Expiration: See Plans and Pricing

Australia

Patent: 07263261
Estimated Expiration: See Plans and Pricing

Brazil

Patent: 0713338
Estimated Expiration: See Plans and Pricing

Canada

Patent: 54872
Estimated Expiration: See Plans and Pricing

Chile

Patent: 07001837
Estimated Expiration: See Plans and Pricing

China

Patent: 1472566
Estimated Expiration: See Plans and Pricing

Ecuador

Patent: 088986
Estimated Expiration: See Plans and Pricing

European Patent Office

Patent: 34968
Estimated Expiration: See Plans and Pricing

Patent: 11439
Estimated Expiration: See Plans and Pricing

Patent: 91878
Estimated Expiration: See Plans and Pricing

Guatemala

Patent: 0800297
Estimated Expiration: See Plans and Pricing

Israel

Patent: 5425
Estimated Expiration: See Plans and Pricing

Japan

Patent: 62556
Estimated Expiration: See Plans and Pricing

Patent: 09541239
Estimated Expiration: See Plans and Pricing

Malaysia

Patent: 6779
Estimated Expiration: See Plans and Pricing

Mexico

Patent: 08016533
Estimated Expiration: See Plans and Pricing

Morocco

Patent: 527
Estimated Expiration: See Plans and Pricing

New Zealand

Patent: 2937
Estimated Expiration: See Plans and Pricing

Norway

Patent: 090262
Estimated Expiration: See Plans and Pricing

Peru

Patent: 080373
Estimated Expiration: See Plans and Pricing

Patent: 120990
Estimated Expiration: See Plans and Pricing

Russian Federation

Patent: 91058
Estimated Expiration: See Plans and Pricing

Patent: 09101971
Estimated Expiration: See Plans and Pricing

South Africa

Patent: 0809773
Estimated Expiration: See Plans and Pricing

South Korea

Patent: 1442272
Estimated Expiration: See Plans and Pricing

Patent: 090021353
Estimated Expiration: See Plans and Pricing

Spain

Patent: 04979
Estimated Expiration: See Plans and Pricing

Taiwan

Patent: 57137
Estimated Expiration: See Plans and Pricing

Patent: 0808358
Estimated Expiration: See Plans and Pricing

Tunisia

Patent: 08528
Estimated Expiration: See Plans and Pricing

United Kingdom

Patent: 12540
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 HCT around the world.

Country Patent Number Title Estimated Expiration
Canada 2147044 See Plans and Pricing
Norway 20032233 See Plans and Pricing
Greece 3031997 See Plans and Pricing
Portugal 1341533 See Plans and Pricing
Russian Federation 2491058 ГАЛЕНОВЫЙ СОСТАВ АЛИСКИРЕНА И ГИДРОХЛОРТИАЗИДА (GALENA COMPOSITION OF ALISKIREN AND HYDROCHLOROTHIAZIDE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for TEKTURNA HCT

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
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
1507558 113 5008-2012 Slovakia See Plans and Pricing PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705
1915993 132013902215595 Italy See Plans and Pricing PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E AMLODIPINA O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILAMLO); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/11/686/001-056, 20110414
1507558 CR 2012 00018 Denmark See Plans and Pricing PRODUCT 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
0678503 CA 2007 00049 Denmark See Plans and Pricing
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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Serving leading biopharmaceutical companies globally:

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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 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.