Orange Book product · Brand (NDA)

AUVI-Q

EPINEPHRINE

Brand (NDA)NDA 201739RX KALEO INC

Nov 17, 2017

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 17, 2017
8 yr 9 mo ago
Today
Patent 11590286 expires
Listed drug product patent expiration.
Dec 12, 2026
in 6 mo
Patent 8206360 expires
Listed drug product patent expiration.
Feb 27, 2027
in 8 mo
Patent 7947017 expires
Listed drug product patent expiration.
Mar 12, 2028
in 1 yr 9 mo
Patent 8231573 expires
Listed drug product patent expiration.
Nov 25, 2028
in 2 yr 6 mo
Patent 8226610 expires
Listed drug product patent expiration.
Apr 10, 2029
in 2 yr 10 mo
Patent 8021344 expires
Listed drug product patent expiration.
Nov 02, 2029
in 3 yr 5 mo
Patent 10688244 expires
Listed drug product patent expiration.
Dec 21, 2037
in 11 yr 8 mo
Patent 10842938 expires
Listed drug product patent expiration.
Dec 21, 2037
in 11 yr 8 mo
Patent 11771830 expires
Listed drug product patent expiration.
Dec 21, 2037
in 11 yr 8 mo

Active ingredient

EPINEPHRINE

Strength

EQ 0.1MG/DELIVERY

Dosage form

SOLUTION

Route

INTRAMUSCULAR, SUBCUTANEOUS

TE code

Not listed

Application

NDA 201739

Product number

003

Marketing status

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
11590286	Dec 12, 2026	in 6 mo	Product
8206360	Feb 27, 2027	in 8 mo	Product
7947017	Mar 12, 2028	in 1 yr 9 mo	Product
8231573	Nov 25, 2028	in 2 yr 6 mo	Product
8226610	Apr 10, 2029	in 2 yr 10 mo	Product
8021344	Nov 02, 2029	in 3 yr 5 mo	Product
10688244	Dec 21, 2037	in 11 yr 8 mo	ProductU-2980
10842938	Dec 21, 2037	in 11 yr 8 mo	ProductU-2980
11771830	Dec 21, 2037	in 11 yr 8 mo	ProductU-2980