Orange Book product · Brand (NDA)

BUNAVAIL

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 205637DISCN BDSI

Jun 06, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jun 06, 2014
12 yr 3 mo ago
Today
Patent 8147866 expires
Listed drug product patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Patent 9655843 expires
Listed drug product patent expiration.
Jul 23, 2027
in 1 yr 1 mo
Patent 8703177 expires
Listed drug product patent expiration.
Aug 20, 2032
in 6 yr 3 mo
Patent 9522188 expires
Listed drug product patent expiration.
Apr 24, 2035
in 9 yr

Active ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Strength

EQ 6.3MG BASE;EQ 1MG BASE

Dosage form

FILM

Route

BUCCAL

TE code

Not listed

Application

NDA 205637

Product number

003

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
8147866	Jul 23, 2027	in 1 yr 1 mo	ProductU-1521
9655843	Jul 23, 2027	in 1 yr 1 mo	ProductU-2017
8703177	Aug 20, 2032	in 6 yr 3 mo	Product
9522188	Apr 24, 2035	in 9 yr	Product