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:	123
Formulation / Manufacturing:	see details
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

Anatomical Therapeutic Chemical (ATC) Classes for TEKTURNA

C09XA	Renin-inhibitors
C09X	OTHER AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C09	AGENTS ACTING ON THE RENIN-ANGIOTENSIN SYSTEM
C	Cardiovascular system

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: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial

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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	⤷ Try a Trial	⤷ Try a Trial				⤷ Try a Trial
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-004	Jan 18, 2008		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Noden Pharma	TEKTURNA HCT	aliskiren hemifumarate; hydrochlorothiazide	TABLET;ORAL	022107-001	Jan 18, 2008		DISCN	Yes	No	⤷ Try a Trial	⤷ Try a Trial	Y			⤷ Try a Trial
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-001	Mar 5, 2007	AB	RX	Yes	No	⤷ Try a Trial	⤷ Try a Trial			Y	⤷ Try a Trial
>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	⤷ Try a Trial	⤷ Try a Trial
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	⤷ Try a Trial	⤷ Try a Trial
>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
Germany	59506707		⤷ Try a Trial
Germany	122007000071		⤷ Try a Trial
Ecuador	SP066807	FORMULACIONES GALÉNICAS DE COMPUESTOS ORGÁNICOS	⤷ Try a Trial
China	1266118		⤷ Try a Trial
>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
2305232	132019000000150	Italy	⤷ Try a Trial	PRODUCT NAME: ALISKIREN O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE E IDROCLOROTIAZIDE O UN SUO SALE FARMACEUTICAMENTE ACCETTABILE(RASILEZ HCT); AUTHORISATION NUMBER(S) AND DATE(S): EU/1/08/491, 20090120
0678503	C300499	Netherlands	⤷ Try a Trial	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
0678503	CA 2009 00009	Denmark	⤷ Try a Trial
0678503	91373	Luxembourg	⤷ Try a Trial	91373, EXPIRES: 20200407
>Patent Number	>Supplementary Protection Certificate	>SPC Country	>SPC Expiration	>SPC Description