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Generated: May 23, 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. It is available from one supplier. 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. One supplier is listed 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
Generic Entry Opportunity Date for 206302
Generic Entry Date for 206302*:
Constraining patent/regulatory exclusivity:
NEW COMBINATION
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.

Pharmacology for NDA: 206302
Suppliers and Packaging for NDA: 206302
Tradename Generic Name Dosage NDA Application Type Supplier National Drug Code Package Code Package
BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302 NDA Allergan, Inc. 0023-5874 0023-5874-30 30 TABLET, FILM COATED in 1 BOTTLE (0023-5874-30)
BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302 NDA Allergan, Inc. 0023-5874 0023-5874-32 5 BOTTLE in 1 TRAY (0023-5874-32) > 30 TABLET, FILM COATED in 1 BOTTLE (0023-5874-31)

Profile for product number 001

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

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