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Last Updated: December 7, 2019

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 one supplier. 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. One supplier is listed for this compound. Additional details are available on the aliskiren hemifumarate; hydrochlorothiazide profile page.
Summary for 022107
Tradename:TEKTURNA HCT
Applicant:Noden Pharma
Ingredient:aliskiren hemifumarate; hydrochlorothiazide
Patents:3
Generic Entry Opportunity Date for 022107
Generic Entry Date for 022107*:
Constraining patent/regulatory exclusivity:
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.

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 Noden Pharma USA, Inc. 70839-112 70839-112-01 100 BLISTER PACK in 1 PACKAGE (70839-112-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK
TEKTURNA HCT aliskiren hemifumarate; hydrochlorothiazide TABLET;ORAL 022107 NDA Noden Pharma USA, Inc. 70839-112 70839-112-30 30 TABLET, FILM COATED in 1 BOTTLE (70839-112-30)
Paragraph IV (Patent) Challenges for 022107
Tradename Dosage Ingredient NDA Submissiondate
TEKTURNA HCT TABLET;ORAL aliskiren hemifumarate; hydrochlorothiazide 022107 2014-03-07

Profile for product number 001

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

Expired US Patents for NDA 022107

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

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