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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

aliskiren hemifumarate; valsartan

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?

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

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-001Sep 16, 20095,399,578<disabled>
aliskiren hemifumarate; valsartan
TABLET;ORAL022217-002Sep 16, 20095,399,578<disabled>
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