Orange Book product · Brand (NDA)

AXIRON

TESTOSTERONE

Brand (NDA)NDA 022504DISCN ELI LILLY AND CO

Nov 23, 2010

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Nov 23, 2010
15 yr 10 mo ago
Patent 8993520 expires
Listed method-of-use patent (U-1390) expiration.
Jun 02, 2026
17 d ago
Patent 9180194 expires
Listed method-of-use patent (U-1390) expiration.
Jun 02, 2026
17 d ago
Today
Patent 8419307 expires
Listed method-of-use patent (U-1386) expiration.
Feb 26, 2027
in 8 mo
Patent 8807861 expires
Listed drug product patent expiration.
Feb 26, 2027
in 8 mo
Patent 9289586 expires
Listed method-of-use patent (U-1390) expiration.
Feb 26, 2027
in 8 mo
Patent 8435944 expires
Listed method-of-use patent (U-1390) expiration.
Sep 27, 2027
in 1 yr 4 mo

Active ingredient

TESTOSTERONE

Strength

30MG/1.5ML ACTUATION **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

SOLUTION, METERED

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 022504

Product number

001

Marketing status

DISCN

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
8993520	Jun 02, 2026	17 d ago	U-1390
9180194	Jun 02, 2026	17 d ago	U-1390
8419307	Feb 26, 2027	in 8 mo	U-1386
8807861	Feb 26, 2027	in 8 mo	ProductU-1563
9289586	Feb 26, 2027	in 8 mo	U-1390
8435944	Sep 27, 2027	in 1 yr 4 mo	U-1390