Viewing data from:

GELNIQUE 3%

NDA

OXYBUTYNIN | N202513 | ALLERGAN SALES LLC

1 strength0 unique patents0 unique exclusivities

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

API Supply Chain4 active DMFs2 inactive

4 active API suppliers hold Drug Master Files for this ingredient.

SIEGFRIED EVIONNAZ SAOXYBUTYNIN BASE

DMF 119471996

CORDEN PHARMA CHENOVEOXYBUTYNIN HYDROCHLORIDE

DMF 123091997

PCASOXYBUTYNIN BASE

DMF 130841998

TAPI NL BVOXYBUTYNIN BASE

DMF 260772012

SELOC AGInactiveOXYBUTYNIN BASE

DMF 114781995

JUZEN CHEMICAL CORPInactiveOXYBUTYNIN

DMF 140711999

Source: FDA Drug Master Files (fda.gov). Type II API DMFs matched by ingredient.

Approval Letters

3 letters from Drugs@FDA

Source: Drugs@FDA application documents.

Products (1)

#001 — 3%

RLD

0 patents0 exclusivities▴

GEL, METERED;TRANSDERMAL | Approved: Dec 7, 2011

No patent or exclusivity listings for this strength.