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Serving hundreds of leading biopharmaceutical companies globally:

QuintilesIMS
Fish and Richardson
Federal Trade Commission
Harvard Business School
UBS
Chubb
Merck
Cantor Fitzgerald
US Army

Generated: July 21, 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. Two suppliers are listed 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
Suppliers / Packagers: 2
Clinical Trials: 17
Formulation / Manufacturing:see details
DailyMed Link:TEKTURNA HCT at DailyMed
Drug patent expirations by year for TEKTURNA HCT
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.

Pharmacology for TEKTURNA HCT
Ingredient-typeThiazides
Drug ClassRenin Inhibitor
Thiazide Diuretic
Mechanism of ActionRenin Inhibitors
Physiological EffectIncreased Diuresis

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 Date
➤ Subscribe Tablets 150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg ➤ Subscribe ➤ Sign Up

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
5,659,065 Alpha-aminoalkanoic acids and reduction products ➤ Sign Up
5,705,658 Azido containing tetrahydro furan compounds ➤ Sign Up
5,606,078 3,5-Disubstituted tetrahydrofuran-2-ones ➤ Sign Up
8,168,616 Combination comprising a renin inhibitor and an angiotensin receptor inhibitor for hypertension ➤ 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
1507558/01 Switzerland ➤ Sign Up PRODUCT NAME: ALISKIREN + AMLODIPIN + HYDROCHLOROTHIAZID; REGISTRATION NO/DATE: SWISSMEDIC 61678 05.07.2011
2009 00010 Denmark ➤ Sign Up PRODUCT NAME: ALISKIREN, SOM DETS FRIE BASE ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, SAMT HYDROCHLORTHIAZID ELLER DETS FARMACEUTISK ACCEPTABLE SALTFORM, HERUNDER ALISKIREN HEMIFUMARAT OG HYDROCHLORTHIAZID; NAT. REG. NO/DATE: EU/1/08/491/001-080 20090116; FIRST REG. NO/DATE: CH 58935 01-04 20081028
0678503/01 Switzerland ➤ Sign Up PRODUCT NAME: ALISKIREN; REGISTRATION NUMBER/DATE: SWISSMEDIC 58050 29.06.2007
2012 00018 Denmark ➤ Sign Up 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
Supplementary Protection Certificate SPC Country SPC Expiration SPC Description

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Serving hundreds of leading biopharmaceutical companies globally:

Healthtrust
UBS
Federal Trade Commission
Cerilliant
Covington
Harvard Business School
Boehringer Ingelheim
McKinsey
Farmers Insurance

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.