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Last Updated: January 20, 2020

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TEKTURNA Drug Profile

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

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

This drug has one hundred and six patent family members in thirty-four 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.

US ANDA Litigation and Generic Entry Outlook for Tekturna

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

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

Recent Litigation for TEKTURNA

Identify potential future generic entrants

District Court Litigation
Case NameDate
Noden Pharma DAC v. Anchen Pharmaceuticals, Inc.2017-06-12

See all TEKTURNA litigation

Pharmacology for TEKTURNA
Drug ClassRenin Inhibitor
Mechanism of ActionRenin Inhibitors
Synonyms for TEKTURNA
(2s,4s,5s,7s)-5-amino-N-(2-carbamoyl-2-methylpropyl)-4-hydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonanamide
(2S,4S,5S,7S)-5-AMINO-N-(2-CARBAMOYL-2-METHYLPROPYL)-4-HYDROXY-2-ISOPROPYL-7-[4-METHOXY-3-(3-METHOXYPROPOXY)BENZYL]-8-METHYLNONANAMIDE
(2S,4S,5S,7S)-5-amino-N-(2-carbamoyl-2,2-dimethylethyl)-4-hydroxy-7-{[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl}-8-methyl-2-(propan-2-yl)nonanamide
(2S,4S,5S,7S)-5-Amino-N-(2-carbamoyl)-2-methylpropyl)-4-hydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonamide
(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxo-propyl)-4-hydroxy-2-isopropyl-7-[[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl]-8-methyl-nonanamide
(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-h
(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-[[4-methoxy-3-(3-methoxypropoxy)phenyl]methyl]-8-methyl-2-propan-2-ylnonanamide
(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-[4-methoxy-3-(3-methoxypropoxy)benzyl]-8-methyl-2-(1-methylethyl)nonanamide
(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-7-[4-methoxy-3-(3-methoxypropoxy)benzyl]-8-methyl-2-(propan-2-yl)nonanamide
(2S,4S,5S,7S)-5-amino-N-[2-carbamoyl-2-methylpropyl)-4-hydroxy-2-isopropyl-7-[4-methoxy-3-(3-methoxypropoxy)benzyl]-8-methylnonanamide
(2s,4s,5s,7s)-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-5-amino-n-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-2-isopropyl-8-methylnonanamide
(aS,S,dS,zS)-d-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)--hydroxy-4-methoxy-3-(3-methoxypropoxy)-a,z-bis(1-methylethyl)benzeneoctanamide
173334-57-1
2(S),4(S),5(S),7(S)-N-(2-carbamoyl-2-methylpropyl)-5-amino-4-hydroxy-2,7-diisopropyl-8-(4-methoxy-3-(3-methoxypropoxy)phenyl)octanamid hemifumarate
334A582
401809-63-0
5(S)-Amino-4(S)-hydroxy-2(S),7(S)-diisopropyl-8-[4-methoxy-3-(3-methoxypropyloxy)-phenyl]-octanoic acid N-(2-carbamoyl-2,2-dimethyl-ethyl)-amide
502FWN4Q32
957114-21-5
AB0015554
AB01274865_02
AB01274865_03
AB01274865-01
AC1NUU28
AK198681
AKOS015852572
AKOS015888741
ALBB-027274
Aliskiren
Aliskiren (USAN/INN)
Aliskiren [USAN:INN:BAN]
Aliskiren fumarate
Aliskiren(CGP 60536)
AN-6371
API0006243
BDBM17950
Benzeneoctanamide, delta-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-gamma-hydroxy-4-methoxy-3-(3-methoxypropoxy)-alpha,zeta-bis-(1-methylethyl)-, (alphaS,gammaS,deltaS,zetaS)-
benzeneoctanamide, delta-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-gamma-hydroxy-4-methoxy-3-(3-methoxypropoxy)-alpha,zeta-bis(1-methylethyl)-, (alphaS,gammaS,deltaS,zetaS)-, fumarate
BRD-K30020243-051-01-7
C30H53N3O6
C41
CGP 60536
CGP-060536B
CGP-60536
CGP60536
CGP60536B
CHEBI:601027
CHEMBL1639
CS-0443
D03208
DB09026
EBD49928
Enviage
FT-0658127
GTPL4812
HSDB 7843
HY-12176
KS-00000FLR
MCULE-6209020635
MolPort-006-167-755
NCGC00186464-01
NCGC00186464-02
Q-4363
Rasilez
Rasilez (TN)
Riprazo
SBI-0206888.P001
SC-20610
SCHEMBL455490
SPP 100
SPP100
Sprimeo
STL386835
UNII-502FWN4Q32
UXOWGYHJODZGMF-QORCZRPOSA-N
ydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonanamide
ZINC4393164
Paragraph IV (Patent) Challenges for TEKTURNA
Tradename Dosage Ingredient NDA Submissiondate
TEKTURNA TABLET;ORAL aliskiren hemifumarate 021985 2014-01-27

US Patents and Regulatory Information for TEKTURNA

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   Start Trial   Start Trial   Start Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-004 Jan 18, 2008 RX Yes Yes   Start Trial   Start Trial   Start Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-001 Jan 18, 2008 RX Yes No   Start Trial   Start Trial Y   Start Trial
Noden Pharma TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985-001 Mar 5, 2007 AB RX Yes No   Start Trial   Start Trial Y   Start Trial
Noden Pharma TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107-002 Jan 18, 2008 RX Yes No   Start Trial   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Supplementary Protection Certificates for TEKTURNA

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1507558 122012000031 Germany   Start Trial 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
1915993 13C0063 France   Start 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
0678503 C00678503/04 Switzerland   Start Trial PRODUCT NAME: ALISKIREN + AMLODIPIN; REGISTRATION NO/DATE: SWISSMEDIC 61454 05.07.2011
0678503 C00678503/02 Switzerland   Start Trial PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
1507558 2012/018 Ireland   Start Trial 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
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

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AstraZeneca
Mallinckrodt
Medtronic
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