Orange Book product · Brand (NDA)

EVZIO

NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 205787DISCN KALEO INC

View NALOXONE HYDROCHLORIDE family Open on FDA Orange Book

At a glance

Apr 03, 2014

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Key dates

Approval
FDA approval date of this drug product.
Apr 03, 2014
12 yr 5 mo ago
Patent 9278182 expires
Listed drug product patent expiration.
Feb 01, 2026
5 mo ago
Patent 8926594 expires
Listed drug product patent expiration.
Mar 31, 2026
3 mo ago
Patent 7731686 expires
Listed drug product patent expiration.
Jun 10, 2026
9 d ago
Today
Patent 10960155 expires
Listed drug product patent expiration.
Jun 25, 2026
in 6 d
Patent 11590286 expires
Listed drug product patent expiration.
Dec 12, 2026
in 6 mo
Patent 9238108 expires
Listed drug product patent expiration.
Feb 20, 2027
in 8 mo
Patent 8206360 expires
Listed drug product patent expiration.
Feb 27, 2027
in 8 mo
Patent 9724471 expires
Listed drug product patent expiration.
May 23, 2027
in 11 mo
Patent 7947017 expires
Listed drug product patent expiration.
Mar 12, 2028
in 1 yr 9 mo
Patent 7749194 expires
Listed drug product patent expiration.
Oct 30, 2028
in 2 yr 5 mo
Patent 8231573 expires
Listed drug product patent expiration.
Nov 25, 2028
in 2 yr 6 mo
Patent 8226610 expires
Listed drug product patent expiration.
Apr 10, 2029
in 2 yr 10 mo
Patent 8021344 expires
Listed drug product patent expiration.
Nov 02, 2029
in 3 yr 5 mo
Patent 10322239 expires
Listed method-of-use patent (U-1907) expiration.
Feb 28, 2031
in 4 yr 9 mo
Patent 8939943 expires
Listed drug product patent expiration.
Feb 28, 2031
in 4 yr 9 mo
Patent 9022022 expires
Listed drug product patent expiration.
Feb 28, 2031
in 4 yr 9 mo
Patent 9474869 expires
Listed drug product patent expiration.
Feb 28, 2031
in 4 yr 9 mo
Patent 10143972 expires
Listed method-of-use patent (U-2476) expiration.
May 24, 2031
in 5 yr
Patent 8627816 expires
Listed drug product patent expiration.
Feb 04, 2032
in 5 yr 9 mo
Patent 9517307 expires
Listed drug product patent expiration.
Jul 18, 2034
in 8 yr 2 mo
Patent 10220158 expires
Listed drug product patent expiration.
Mar 20, 2035
in 8 yr 11 mo

Pharmaceutical detail

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

0.4MG/0.4ML (0.4MG/0.4ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, SUBCUTANEOUS

TE code

Not listed

Application

NDA 205787

Product number

001

Marketing status

DISCN

Reference listed drug (RLD)

Yes

Reference standard (RS)

Active-ingredient family

View full family

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

Listed patents (21)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
Patent	Expires	In	Type
9278182	Feb 01, 2026	5 mo ago	Product
8926594	Mar 31, 2026	3 mo ago	Product
7731686	Jun 10, 2026	9 d ago	Product
10960155	Jun 25, 2026	in 6 d	Product
11590286	Dec 12, 2026	in 6 mo	Product
9238108	Feb 20, 2027	in 8 mo	Product
8206360	Feb 27, 2027	in 8 mo	Product
9724471	May 23, 2027	in 11 mo	ProductU-2092
7947017	Mar 12, 2028	in 1 yr 9 mo	Product
7749194	Oct 30, 2028	in 2 yr 5 mo	Product
8231573	Nov 25, 2028	in 2 yr 6 mo	Product
8226610	Apr 10, 2029	in 2 yr 10 mo	Product
8021344	Nov 02, 2029	in 3 yr 5 mo	Product
10322239	Feb 28, 2031	in 4 yr 9 mo	U-1907
8939943	Feb 28, 2031	in 4 yr 9 mo	Product
9022022	Feb 28, 2031	in 4 yr 9 mo	Product
9474869	Feb 28, 2031	in 4 yr 9 mo	ProductU-1907
10143972	May 24, 2031	in 5 yr	U-2476
8627816	Feb 04, 2032	in 5 yr 9 mo	Product
9517307	Jul 18, 2034	in 8 yr 2 mo	ProductU-1925
10220158	Mar 20, 2035	in 8 yr 11 mo	ProductU-2500

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