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Serving leading biopharmaceutical companies globally:

Chinese Patent Office
Argus Health
Federal Trade Commission

Generated: February 19, 2018

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 022107

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NDA 022107 describes TEKTURNA HCT, which is a drug marketed by Noden Pharma and is included in one NDA. It is available from two suppliers. There are three patents protecting this drug and one Paragraph IV challenge. Additional details are available on the TEKTURNA HCT profile page.

The generic ingredient in TEKTURNA HCT is aliskiren hemifumarate; hydrochlorothiazide. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
Summary for 022107
Applicant:Noden Pharma
Ingredient:aliskiren hemifumarate; hydrochlorothiazide
Formulation / Manufacturing:see details
Pharmacology for NDA: 022107
Mechanism of ActionRenin Inhibitors
Physiological EffectIncreased Diuresis
Suppliers and Packaging for NDA: 022107
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107 NDA Physicians Total Care, Inc. 54868-6041 E 54868-6041-0
TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107 NDA Physicians Total Care, Inc. 54868-6103 E 54868-6103-0

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE;12.5MG
Approval Date:Jan 18, 2008TE:RLD:Yes
Patent:➤ Sign UpPatent Expiration:Jan 21, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Sign UpPatent Expiration:Jul 13, 2028Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Mar 3, 2022Product Flag?YSubstance Flag?Delist Request?

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