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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

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

Summary for TEKTURNA

International Patents:	106
US Patents:	2
Applicants:	1
NDAs:	3
Suppliers / Packagers:	2
Bulk Api Vendors:	56
Clinical Trials:	17
Patent Applications:	825
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TEKTURNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEKTURNA
DailyMed Link:	TEKTURNA at DailyMed

See drug prices for TEKTURNA

Recent Clinical Trials for TEKTURNA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Wayne State University	Phase 4
University of Alabama at Birmingham	Phase 4
Mayo Clinic	N/A

See all TEKTURNA clinical trials

Recent Litigation for TEKTURNA

Identify potential future generic entrants

District Court Litigation

Case Name	Date
Noden Pharma DAC v. Anchen Pharmaceuticals, Inc.	2017-06-12

See all TEKTURNA litigation

Pharmacology for TEKTURNA

Drug Class	Renin Inhibitor
Mechanism of Action	Renin 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
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		RX	Yes	Yes
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		RX	Yes	No			Y
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No					Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008		RX	Yes	No

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
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007

International Patents for TEKTURNA

Country	Patent Number	Estimated Expiration
Japan	2007529456
Peru	20142101
Malaysia	148773
Hong Kong	1070881
Australia	2005224010

Supplementary Protection Certificates for TEKTURNA

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