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Details for New Drug Application (NDA): 022217

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NDA 022217 describes VALTURNA, 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 VALTURNA profile page.

The generic ingredient in VALTURNA is aliskiren hemifumarate; valsartan. There are four drug master file entries for this compound. Additional details are available on the aliskiren hemifumarate; valsartan profile page.

Summary for NDA: 022217

Tradename:
VALTURNA
Applicant:
Novartis
Ingredient:
aliskiren hemifumarate; valsartan
Patents:2
Formulation / Manufacturing:see details

Summary for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 150MG BASE;160MG
Approval Date:Sep 16, 2009TE:RLD:No
Patent:8,168,616Patent Expiration:Jul 3, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:5,559,111Patent Expiration:Jul 21, 2018Product Flag?YSubstance Flag?YDelist Request?
Patented Use:TREATMENT OF HYPERTENSION

Summary for product number 002

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 300MG BASE;320MG
Approval Date:Sep 16, 2009TE:RLD:No
Patent:8,168,616Patent Expiration:Jul 3, 2026Product Flag?YSubstance Flag?Delist Request?

Expired Orange Book Patents for NDA: 022217

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-001Sep 16, 20095,399,578► subscribe
Novartis
VALTURNA
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 20095,399,578► subscribe
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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 verifification 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.

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