Orange Book product · Brand (NDA)

NALOXONE HYDROCHLORIDE (AUTOINJECTOR)

NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 215457DISCN KALEO INC

Feb 28, 2022

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Feb 28, 2022
4 yr 4 mo ago
Today
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 9814838 expires
Listed drug product patent expiration.
Feb 28, 2031
in 4 yr 9 mo
Patent 10143792 expires
Listed method-of-use patent (U-2476) expiration.
May 24, 2031
in 5 yr

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

10MG/0.4ML (10MG/0.4ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, SUBCUTANEOUS

TE code

Not listed

Application

NDA 215457

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
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
9814838	Feb 28, 2031	in 4 yr 9 mo	Product
10143792	May 24, 2031	in 5 yr	U-2476