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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 five 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.

Summary for TEKTURNA

International Patents:	105
US Patents:	2
Applicants:	1
NDAs:	3
Suppliers / Packagers:	2
Bulk Api Vendors:	42
Clinical Trials:	17
Patent Applications:	23
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TEKTURNA
DailyMed Link:	TEKTURNA at DailyMed

Generic Entry Opportunity Date for TEKTURNA

Constraining patent/regulatory exclusivity:

PEDIATRIC EXCLUSIVITY

NDA:

210709

Dosage:

CAPSULE, PELLET;ORAL

NDA:

021985

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

Drug Class	Renin Inhibitor
Mechanism of Action	Renin Inhibitors

Synonyms for TEKTURNA

(?S,?S,?S,?S)-?-Amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-?-hydroxy-4-methoxy-3-(3-methoxypropoxy)-?,?-bis(1-methylethyl)benzeneoctanamide hemifumarate

(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; fumaric acid

(2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonanamide hemifumarate

(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; (E)-but-2-enedioic acid

1196835-68-3

173334-58-2

2C30H53N3O6.C4H4O4

AB0009979

ABP000691

AC1OCFF2

AK174311

AKOS015896419

Aliskiren (hemifumarate)

Aliskiren fumarate

Aliskiren fumarate (JAN/USAN)

Aliskiren fumarate [USAN:JAN]

Aliskiren hemifumarate

Aliskiren hemifumarate/

AN-6892

AT-45505

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)-, (2E)-2-butenedioate (2:1) (salt)

bis((2S,4S,5S,7S)-5-amino-N-(3-amino-2,2-dimethyl-3-oxopropyl)-4-hydroxy-2-isopropyl-7-(4-methoxy-3-(3-methoxypropoxy)benzyl)-8-methylnonanamide) fumarate

Bis(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) (2E)-but-2-enedioate

bis{(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} (2E)-but-2-enedioate

C8A0P8G029

CGP 60536

CGP-60536

CGP-60536B

CHEBI:53777

CHEMBL3545059

CS-0729

D06412

EN300-122378

Enviage

fumaric acid; bis(tekturna)

HY-12177

I06-2020

J10437

KB-47181

KLRSDBSKUSSCGU-KRQUFFFQSA-N

KS-1395

MolPort-008-155-823

Riprazo

SCHEMBL187762

SPP-100

SPP-100B

Sprimeo

Tekturna (TN)

UNII-C8A0P8G029

W-5448

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					Y
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		RX	Yes	No					Y

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Paragraph IV (Patent) Challenges for TEKTURNA

Drugname	Dosage	Strength	RLD	Date
	Tablets	150 mg and 300 mg
	Tablets	150 mg/12.5 mg, 150 mg/25 mg, 300 mg/12.5 mg, 300 mg/25 mg

Non-Orange Book US Patents for TEKTURNA

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
8,007,824	Galenic formulations of organic compounds
5,606,078	3,5-Disubstituted tetrahydrofuran-2-ones
5,659,065	Alpha-aminoalkanoic acids and reduction products
5,646,143	.delta.-amino-.gamma.-hydroxy-.omega.-aryl-alkanoic acid amides

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International Patents for TEKTURNA

Country	Document Number	Estimated Expiration
Netherlands	300386
Japan	H0881430
China	1153759
Hungary	9501076

Supplementary Protection Certificates for TEKTURNA

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2007 00049	Denmark
/2009	Austria		PRODUCT NAME: KOMBINATION ENTHALTEND ALISKIREN ALS FREIE BASE ODER ALS PHARMAZEUTISCH AKZEPTABLES SALZ DAVON, UND HYDROCHLORTHIAZID ODER EIN PHARMAZEUTISCH AKZEPTABLES SALZ DAVON; NAT. REGISTRATION NO/DATE: EU/1/08/491/001-080 20090116; FIRST REGISTRATION: LI 58935 20081028
C0055	France		PRODUCT NAME: ALISKIREN; REGISTRATION NO/DATE: EU/1/07/405/001-020 20070822
90018-9	Sweden		PRODUCT NAME: ALISKIREN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, AMLODIPIN ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH HYDROKLORTIAZID ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV; NAT. REGISTRATIPON NO/DATE: EU/1/11/730 20111122; FIRST REGISTRATION: CH 61678 01-05 20110705