TEKTURNA Drug Patent Profile

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Which patents cover Tekturna, and when can generic versions of Tekturna launch?

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

This drug has forty patent family members in twenty-two countries.

The generic ingredient in TEKTURNA is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.

DrugPatentWatch^® Generic Entry Outlook for Tekturna

Tekturna was eligible for patent challenges on March 5, 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.

Indicators of Generic Entry

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Summary for TEKTURNA

International Patents:	40
US Patents:	1
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	63
Clinical Trials:	18
Patent Applications:	100
Drug Prices:	Drug price information for TEKTURNA
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for TEKTURNA
What excipients (inactive ingredients) are in TEKTURNA?	TEKTURNA excipients list
DailyMed Link:	TEKTURNA at DailyMed

Drug patent expirations by year 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

Pharmacology for TEKTURNA

Drug Class	Renin Inhibitor
Mechanism of Action	Renin Inhibitors

Paragraph IV (Patent) Challenges for TEKTURNA

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
TEKTURNA	Tablets	aliskiren hemifumarate	150 mg and 300 mg	021985	1	2014-01-27

US Patents and Regulatory Information for TEKTURNA

TEKTURNA is protected by one US patents.

Patents protecting TEKTURNA

Galenic formulations of organic compounds
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

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Glossary

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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	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No	⤷ 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

Expired US Patents for TEKTURNA

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	⤷ Sign Up	⤷ Sign Up
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for TEKTURNA

See the table below for patents covering TEKTURNA around the world.

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Country	Patent Number	Title	Estimated Expiration
Ecuador	SP066807	FORMULACIONES GALÉNICAS DE COMPUESTOS ORGÁNICOS	⤷ Sign Up
Argentina	048431	FORMULACIONES GALENICAS DE COMPUESTOS ORGANICOS	⤷ Sign Up
Norway	20064670		⤷ Sign Up
China	1117960		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration

Supplementary Protection Certificates for TEKTURNA

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Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1915993	1390055-0	Sweden	⤷ Sign Up	PRODUCT NAME: KOMBINATION INNEFATTANDE ALISKIREN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV, OCH AMLODIPIN, ELLER ETT FARMACEUTISKT ACCEPTABELT SALT DAERAV.; REG. NO/DATE: EU/1/11/686/001 20110414
2305232	C201930070	Spain	⤷ Sign Up	PRODUCT NAME: ALISKIREN HEMIFUMARATO + HIDROCLOROTIAZIDA; NATIONAL AUTHORISATION NUMBER: EU/1/08/491/001-080; DATE OF AUTHORISATION: 20090116; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/08/491/001-080; DATE OF FIRST AUTHORISATION IN EEA: 20090116
1915993	2013C/068	Belgium	⤷ Sign Up	PRODUCT NAME: COMBINAISON COMPRENANT L'ALISKIREN OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET L'AMLOPINE OU UN DE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES; AUTHORISATION NUMBER AND DATE: EU/1/11/686/001 20110415
1507558	12C0033	France	⤷ Sign Up	PRODUCT NAME: ALISKIRENE OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE E CELUI-CI, AMLODIPINE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI, ET HYDROCHLOROTHIAZIDE OU SEL PHARMACEUTIQUEMENT ACCEPTABLE DE CELUI-CI; NAT. REGISTRATION NO/DATE: EU/1/11/730/001 20111122; FIRST REGISTRATION: CH - 6167801 20110705
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description