Make Better Decisions - Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Finding and Evaluating Generic and Branded Drug Market Entry Opportunities

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Last Updated: December 11, 2019

DrugPatentWatch Database Preview

Details for New Drug Application (NDA): 206302

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NDA 206302 describes BYVALSON, which is a drug marketed by Allergan Sales Llc and is included in one NDA. There are two patents protecting this drug and one Paragraph IV challenge. Additional details are available on the BYVALSON profile page.

The generic ingredient in BYVALSON is nebivolol hydrochloride; valsartan. There are fourteen drug master file entries for this compound. Additional details are available on the nebivolol hydrochloride; valsartan profile page.
Summary for 206302
Tradename:BYVALSON
Applicant:Allergan Sales Llc
Ingredient:nebivolol hydrochloride; valsartan
Patents:2
Paragraph IV (Patent) Challenges for 206302
Tradename Dosage Ingredient NDA Submissiondate
BYVALSON TABLET;ORAL nebivolol hydrochloride; valsartan 206302 2017-06-09

Profile for product number 001

Active Rx/OTC/Discontinued:DISCNDosage:TABLET;ORALStrengthEQ 5MG BASE;80MG
Approval Date:Jun 3, 2016TE:RLD:Yes
Regulatory Exclusivity Expiration:Jun 3, 2019
Regulatory Exclusivity Use:NEW COMBINATION
Patent:  Start TrialPatent Expiration:Aug 29, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:  Start TrialPatent Expiration:Oct 4, 2027Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF TREATING HYPERTENSION

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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