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Last Updated: March 28, 2024

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. There is one patent 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. 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:1
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) 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.

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 18, 2008TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 13, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE;25MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 18, 2008TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 13, 2028Product Flag?YSubstance Flag?Delist Request?

Profile for product number 003

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 300MG BASE;12.5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Approval Date:Jan 18, 2008TE:RLD:Yes
Patent:⤷  Try a TrialPatent Expiration:Jul 13, 2028Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 022107

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.