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Last Updated: December 9, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 200045

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NDA 200045 describes AMTURNIDE, which is a drug marketed by Novartis and is included in one NDA. There are two patents protecting this drug. Additional details are available on the AMTURNIDE profile page.

The generic ingredient in AMTURNIDE is aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; amlodipine besylate; hydrochlorothiazide profile page.
Summary for 200045
Generic Entry Opportunity Date for 200045
Generic Entry Date for 200045*:
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;EQ 5MG BASE;12.5MG
Approval Date:Dec 21, 2010TE:RLD:No
Patent:  Start TrialPatent Expiration:May 16, 2023Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Nov 15, 2021Product Flag?YSubstance Flag?Delist Request?

Profile for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 300MG BASE;EQ 5MG BASE;12.5MG
Approval Date:Dec 21, 2010TE:RLD:No
Patent:  Start TrialPatent Expiration:May 16, 2023Product Flag?YSubstance Flag?Delist Request?

Expired US Patents for NDA 200045

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