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Serving hundreds of leading biopharmaceutical companies globally:

Express Scripts
Argus Health
Cantor Fitzgerald
Federal Trade Commission
Boehringer Ingelheim

Generated: June 23, 2018

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
Applicant:Allergan Sales Llc
Ingredient:nebivolol hydrochloride; valsartan
Formulation / Manufacturing:see details
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 N 0023-5874-30
BYVALSON nebivolol hydrochloride; valsartan TABLET;ORAL 206302 NDA Allergan, Inc 0023-5874 N 0023-5874-32

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:➤ Sign UpPatent Expiration:Aug 29, 2026Product Flag?YSubstance Flag?Delist Request?
Patent:➤ Sign UpPatent Expiration:Oct 4, 2027Product Flag?Substance Flag?Delist Request?

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Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
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Farmers Insurance

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