Details for New Drug Application (NDA): 021985

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NDA 021985 describes TEKTURNA, which is a drug marketed by Noden Pharma and is included in three NDAs. It is available from three suppliers. There are two patents protecting this drug and two Paragraph IV challenges. Additional details are available on the TEKTURNA profile page.

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.

Summary for 021985

Tradename:	TEKTURNA
Applicant:	Noden Pharma
Ingredient:	aliskiren hemifumarate
Patents:	1

Pharmacology for NDA: 021985

Mechanism of Action	Renin Inhibitors

Suppliers and Packaging for NDA: 021985

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985	NDA	A-S Medication Solutions	50090-2985	50090-2985-0	30 TABLET, FILM COATED in 1 BOTTLE (50090-2985-0)
TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985	NDA AUTHORIZED GENERIC	Prasco Laboratories	66993-141	66993-141-30	30 TABLET, FILM COATED in 1 BOTTLE (66993-141-30)

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 150MG BASE
Approval Date:	Mar 5, 2007	TE:	AB	RLD:	Yes
Patent:	8,617,595*PED	Patent Expiration:	Aug 19, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Profile for product number 002

Active Rx/OTC/Discontinued:	RX	Dosage:	TABLET;ORAL			Strength	EQ 300MG BASE
Approval Date:	Mar 5, 2007	TE:	AB	RLD:	Yes
Patent:	8,617,595*PED	Patent Expiration:	Aug 19, 2026	Product Flag?		Substance Flag?		Delist Request?	Y

Expired US Patents for NDA 021985

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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	5,559,111*PED	⤷ Subscribe
Noden Pharma	TEKTURNA	aliskiren hemifumarate	TABLET;ORAL	021985-002	Mar 5, 2007	5,559,111*PED	⤷ Subscribe
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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