Orange Book product · Brand (NDA)

ZIMHI

NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 212854RX ZMI PHARMA

Oct 15, 2021

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Oct 15, 2021
4 yr 9 mo ago
Today
Patent 11027072 expires
Listed drug product patent expiration.
May 24, 2039
in 13 yr 1 mo
Patent 11571518 expires
Listed drug product patent expiration.
Jun 14, 2041
in 15 yr 2 mo
Patent 11571518 expires
Listed drug product patent expiration.
Jun 14, 2041
in 15 yr 2 mo
Patent 11571518 expires
Listed drug product patent expiration.
Jun 14, 2041
in 15 yr 2 mo

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

5MG/0.5ML (5MG/0.5ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, SUBCUTANEOUS

TE code

Not listed

Application

NDA 212854

Product number

001

Marketing status

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

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
11027072	May 24, 2039	in 13 yr 1 mo	Product
11571518	Jun 14, 2041	in 15 yr 2 mo	ProductU-3515
11571518	Jun 14, 2041	in 15 yr 2 mo	ProductU-3516
11571518	Jun 14, 2041	in 15 yr 2 mo	ProductU-3517