Orange Book product · Brand (NDA)

GELNIQUE

OXYBUTYNIN CHLORIDE

Brand (NDA)NDA 022204DISCN ABBVIE

Jan 27, 2009

Approved

Brand (NDA)

Application

Not listed

TE code

Listed patents

Approval
FDA approval date of this drug product.
Jan 27, 2009
17 yr 8 mo ago
Today
Patent 10449173 expires
Listed drug product patent expiration.
Nov 06, 2029
in 3 yr 5 mo
Patent 9259388 expires
Listed method-of-use patent (U-1644) expiration.
Nov 06, 2029
in 3 yr 5 mo
Patent 8920392 expires
Listed method-of-use patent (U-1644) expiration.
Mar 26, 2031
in 4 yr 10 mo

Active ingredient

OXYBUTYNIN CHLORIDE

Strength

10% (100MG/PACKET) **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

Dosage form

GEL

Route

TRANSDERMAL

TE code

Not listed

Application

NDA 022204

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
10449173	Nov 06, 2029	in 3 yr 5 mo	ProductU-2637
9259388	Nov 06, 2029	in 3 yr 5 mo	U-1644
8920392	Mar 26, 2031	in 4 yr 10 mo	U-1644