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Generated: November 17, 2018

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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 two suppliers. There are four 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. One supplier is listed 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:2
Formulation / Manufacturing:see details
Generic Entry Opportunity Date for 021985
Generic Entry Date for 021985*:
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: 021985
Mechanism of ActionRenin 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 50090-1250 50090-1250-0 30 TABLET, FILM COATED in 1 BOTTLE (50090-1250-0)
TEKTURNA aliskiren hemifumarate TABLET;ORAL 021985 NDA Noden Pharma USA, Inc. 70839-150 70839-150-01 100 BLISTER PACK in 1 PACKAGE (70839-150-01) > 1 TABLET, FILM COATED in 1 BLISTER PACK

Profile for product number 001

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 150MG BASE
Approval Date:Mar 5, 2007TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 21, 2019Product Flag?Substance Flag?Delist Request?Y
Patent:➤ Try a Free TrialPatent Expiration:Aug 19, 2026Product Flag?Substance Flag?Delist Request?Y

Profile for product number 002

Active Rx/OTC/Discontinued:RXDosage:TABLET;ORALStrengthEQ 300MG BASE
Approval Date:Mar 5, 2007TE:RLD:Yes
Patent:➤ Try a Free TrialPatent Expiration:Jan 21, 2019Product Flag?Substance Flag?Delist Request?Y

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