Orange Book product · Brand (NDA)

BYVALSON

NEBIVOLOL HYDROCHLORIDE; VALSARTAN

Brand (NDA)NDA 206302DISCN ABBVIE

Jun 03, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 03, 2016
10 yr 2 mo ago
Today
Patent 7803838 expires
Listed drug product patent expiration.
Aug 29, 2026
in 2 mo
Patent 7838552 expires
Listed method-of-use patent (U-185) expiration.
Oct 04, 2027
in 1 yr 4 mo

Active ingredient

NEBIVOLOL HYDROCHLORIDE; VALSARTAN

Strength

EQ 5MG BASE;80MG

Dosage form

TABLET

Route

ORAL

TE code

Not listed

Application

NDA 206302

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
7803838	Aug 29, 2026	in 2 mo	Product
7838552	Oct 04, 2027	in 1 yr 4 mo	U-185