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Serving hundreds of leading biopharmaceutical companies globally:

AstraZeneca
McKinsey
Teva
Healthtrust
Medtronic
Farmers Insurance
US Department of Justice
Cerilliant
Daiichi Sankyo

Generated: April 24, 2018

DrugPatentWatch Database Preview

TEKTURNA HCT Drug Profile

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When do Tekturna Hct patents expire, and when can generic versions of Tekturna Hct launch?

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

This drug has one hundred and eighty-one patent family members in forty-one countries.

The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
Summary for TEKTURNA HCT
International Patents:181
US Patents:3
Applicants:1
NDAs:1
Clinical Trials: 17
Formulation / Manufacturing:see details
Drug Prices:see details
DailyMed Link:TEKTURNA HCT at DailyMed
Drug patent expirations by year for TEKTURNA HCT

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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-003 Jan 18, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 RX Yes No ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Paragraph IV (Patent) Challenges for TEKTURNA HCT
Drugname Dosage Strength RLD Submissiondate
➤ Subscribe Tablets 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg ➤ Subscribe 2014-03-07

Non-Orange Book US Patents for TEKTURNA HCT

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
9,023,894 Synergistic combinations comprising a renin inhibitor for cardiovascular diseases ➤ Sign Up
8,168,616 Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension ➤ Sign Up
5,646,143 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides ➤ Sign Up
5,654,445 .delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acids ➤ Sign Up
Patent No. Title Estimated Patent Expiration

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Supplementary Protection Certificates for TEKTURNA HCT

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
12/018 Ireland ➤ Sign Up 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
2009 00009 Denmark ➤ Sign Up
2013000093 Germany ➤ Sign Up PRODUCT 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
2012000031 Germany ➤ Sign Up PRODUCT NAME: ALISKIREN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 1), AMLODIPIN ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 2) UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ HIERVON (KOMPONENTE 3); NAT. REGISTRATION NO/DATE: EU/1/11/730/001-060 20111122; FIRST REGISTRATION: SCHWEIZ 61678 01 - 05 20110705
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Julphar
Colorcon
Cantor Fitzgerald
Chubb
Chinese Patent Office
Farmers Insurance
Healthtrust
Mallinckrodt
Argus Health

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.