Orange Book product · Brand (NDA)

SUBOXONE

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 022410TE ABRX INDIVIOR

Aug 10, 2012

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Aug 10, 2012
14 yr 1 mo ago
Today
Patent 11135216 expires
Listed drug product patent expiration.
Aug 07, 2029
in 3 yr 2 mo
Patent 9687454 expires
Listed drug product patent expiration.
Aug 07, 2029
in 3 yr 2 mo
Patent 8475832 expires
Listed drug product patent expiration.
Mar 26, 2030
in 3 yr 10 mo

Active ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Strength

EQ 4MG BASE;EQ 1MG BASE

Dosage form

FILM

Route

BUCCAL, SUBLINGUAL

TE code

Application

NDA 022410

Product number

003

Marketing status

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
11135216	Aug 07, 2029	in 3 yr 2 mo	ProductU-3111
9687454	Aug 07, 2029	in 3 yr 2 mo	ProductU-1464
8475832	Mar 26, 2030	in 3 yr 10 mo	ProductU-1411