Orange Book product · Brand (NDA)

ADRENALIN

EPINEPHRINE

Brand (NDA)NDA 215875RX PH HEALTH

Apr 21, 2023

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Apr 21, 2023
3 yr 3 mo ago
Today
Patent 10653646 expires
Listed drug product patent expiration.
Mar 21, 2039
in 12 yr 11 mo
Patent 11083698 expires
Listed method-of-use patent (U-3567) expiration.
Mar 21, 2039
in 12 yr 11 mo
Patent 11207280 expires
Listed drug product patent expiration.
Mar 21, 2039
in 12 yr 11 mo
Patent 12133837 expires
Listed drug product patent expiration.
Mar 21, 2039
in 12 yr 11 mo

Active ingredient

EPINEPHRINE

Strength

2MG/250ML (8MCG/ML)

Dosage form

SOLUTION

Route

INTRAVENOUS

TE code

Not listed

Application

NDA 215875

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
10653646	Mar 21, 2039	in 12 yr 11 mo	Product
11083698	Mar 21, 2039	in 12 yr 11 mo	U-3567
11207280	Mar 21, 2039	in 12 yr 11 mo	Product
12133837	Mar 21, 2039	in 12 yr 11 mo	Product