Orange Book product · Brand (NDA)

ZUBSOLV

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 204242RX EDENBRIDGE PHARMS

Oct 04, 2016

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 04, 2016
9 yr 10 mo ago
Today
Patent 8658198 expires
Listed drug product patent expiration.
Dec 03, 2027
in 1 yr 6 mo
Patent 8470361 expires
Listed drug product patent expiration.
May 22, 2030
in 4 yr
Patent 10946010 expires
Listed drug product patent expiration.
Sep 18, 2032
in 6 yr 4 mo
Patent 11020388 expires
Listed drug product patent expiration.
Sep 18, 2032
in 6 yr 4 mo
Patent 8940330 expires
Listed drug product patent expiration.
Sep 18, 2032
in 6 yr 4 mo
Patent 9259421 expires
Listed drug product patent expiration.
Sep 18, 2032
in 6 yr 4 mo

Active ingredient

BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE

Strength

EQ 0.7MG BASE;EQ 0.18MG BASE

Dosage form

TABLET

Route

SUBLINGUAL

TE code

Not listed

Application

NDA 204242

Product number

006

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
8658198	Dec 03, 2027	in 1 yr 6 mo	ProductU-1494
8470361	May 22, 2030	in 4 yr	ProductU-1425
10946010	Sep 18, 2032	in 6 yr 4 mo	Product
11020388	Sep 18, 2032	in 6 yr 4 mo	ProductU-3131
8940330	Sep 18, 2032	in 6 yr 4 mo	Product
9259421	Sep 18, 2032	in 6 yr 4 mo	Product