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TEKTURNA HCT Drug Profile

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Which patents cover Tekturna Hct, and what generic alternatives are available?

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

This drug has one hundred and twenty-five patent family members in thirty-nine countries.

The generic ingredient in TEKTURNA HCT 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 Hct

Tekturna Hct was eligible for patent challenges on March 5, 2011.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be July 13, 2028. This may change due to patent challenges or generic licensing.

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.

Indicators of Generic Entry

Summary for TEKTURNA HCT

International Patents:	125
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Clinical Trials:	17
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for TEKTURNA HCT
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEKTURNA HCT
DailyMed Link:	TEKTURNA HCT at DailyMed

See drug prices for TEKTURNA HCT

Generic Entry Opportunity Date for TEKTURNA HCT

NDA:

022107

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.

Recent Clinical Trials for TEKTURNA HCT

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 HCT clinical trials

Recent Litigation for TEKTURNA HCT

Identify potential future generic entrants

District Court Litigation

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

See all TEKTURNA HCT litigation

Pharmacology for TEKTURNA HCT

Drug Class	Renin Inhibitor Thiazide Diuretic
Mechanism of Action	Renin Inhibitors
Physiological Effect	Increased Diuresis

Paragraph IV (Patent) Challenges for TEKTURNA HCT

Tradename	Dosage	Ingredient	NDA	Submissiondate
TEKTURNA HCT	TABLET;ORAL	aliskiren hemifumarate; hydrochlorothiazide	022107	2014-03-07

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			Y
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	022107-002	Jan 18, 2008		RX	Yes	No			Y
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		RX	Yes	Yes			Y

Expired US Patents for TEKTURNA HCT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-002	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-003	Jan 18, 2008

International Patents for TEKTURNA HCT

Country	Patent Number	Estimated Expiration
Denmark	0678503
Israel	155707
New Zealand	270936
Greece	3031997

Supplementary Protection Certificates for TEKTURNA HCT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0678503	C00678503/02	Switzerland		PRODUCT NAME: ALISKIREN UND HYDROCHLOROTHIAZID; REGISTRATION NUMBER/DATE: SWISSMEDIC 58935 28.10.2008
1507558	113 5008-2012	Slovakia		PRODUCT NAME: ALISKIREN / AMLODIPIN / HYDROCHLORTIAZID; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 - EU/1/11/730/060 20111122; FIRST REGISTRATION: CH 61678 01 - 61678 05 20110705
0678503	C300499	Netherlands		PRODUCT NAME: COMBINATIE OMVATTEND ALISKIREN OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN, EN AMLODIPINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN; REGISTRATION NO/DATE: EU/1/11/686/001-056 20110114
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