Orange Book product · Brand (NDA)

RIVIVE

NALOXONE HYDROCHLORIDE

Brand (NDA)NDA 217722OTC HARM REDUCTION THERP

Jul 28, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jul 28, 2023
2 yr 11 mo ago
Today
Patent 11020343 expires
Listed method-of-use patent (U-3671) expiration.
May 11, 2032
in 6 yr
Patent 11806428 expires
Listed drug product patent expiration.
May 11, 2032
in 6 yr
Patent 12458591 expires
Listed method-of-use patent (U-3671) expiration.
May 11, 2032
in 6 yr

Active ingredient

NALOXONE HYDROCHLORIDE

Strength

3MG/SPRAY

Dosage form

SPRAY, METERED

Route

NASAL

TE code

Not listed

Application

NDA 217722

Product number

001

Marketing status

OTC

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
11020343	May 11, 2032	in 6 yr	U-3671
11806428	May 11, 2032	in 6 yr	Product
12458591	May 11, 2032	in 6 yr	U-3671