Orange Book product · Brand (NDA)

ADRENALIN

EPINEPHRINE

Brand (NDA)NDA 204640TE APRX PH HEALTH

Dec 18, 2013

Approved

Brand (NDA)

Application

TE code

Listed patents

Approval
FDA approval date of this drug product.
Dec 18, 2013
12 yr 8 mo ago
Today
Patent 10130592 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 12280024 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 9119876 expires
Listed drug product patent expiration.
Mar 13, 2035
in 8 yr 10 mo
Patent 9295657 expires
Listed method-of-use patent (U-1829) expiration.
Mar 13, 2035
in 8 yr 10 mo

Active ingredient

EPINEPHRINE

Strength

EQ 30MG BASE/30ML (EQ 1MG BASE/ML)

Dosage form

SOLUTION

Route

INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS

TE code

Application

NDA 204640

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
10130592	Mar 13, 2035	in 8 yr 10 mo	Product
12280024	Mar 13, 2035	in 8 yr 10 mo	Product
9119876	Mar 13, 2035	in 8 yr 10 mo	Product
9295657	Mar 13, 2035	in 8 yr 10 mo	U-1829