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OXYTROL

NDA

OXYBUTYNIN | N021351 | 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

Para IV certification filed but no ANDA patent litigation cases (NOS 835) matched from PACER. Litigation may be pending or filed under a different caption.

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

65 trials from ClinicalTrials.gov — 1 recruiting, 57 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
Oxybutynin for Post-surgical Bladder Pain and Urgency NCT03952299	Phase 3	Recruiting	University of California, Davis	100	2021-09-01 → 2026-12-31
A Comparison Study of Oxybutynin and Botulinum Toxin for Neurogenic Detrusor Overactivity NCT01477736	N/A	Completed	Centro de Reabilitação e Readaptação Dr. Henrique Santillo	68	2009-01 → 2010-11
Study of Topically Administered Oxybutynin Gel in Patients With Urge Incontinence NCT00909181	Phase 3	Completed	Antares Pharma Inc.	626	2009-03 → 2010-11
Cognitive Effects of Darifenacin and Oxybutynin Extended Release in Volunteers Aged 60 and Over NCT00170768	Phase 2	Completed	Novartis	150	2005-02 → 2005-05
Cognitive Effects of Oral Oxybutynin and Oxybutynin Chloride Topical Gel in Older Volunteers NCT00752141	Phase 1	Completed	Watson Pharmaceuticals	153	2008-09
A Study Comparing the Efficacy and Safety of OROS® Oxybutynin to That of Ditropan® (Immediate-release Oxybutynin) for the Treatment of Patients With Urge or Mixed Urinary Incontinence.NCT00269750	Phase 3	Completed	Alza Corporation, DE, USA	100	1996-07 → 1997-02
Efficacy and Tolerability of DITROPAN XL (Oxybutynin Chloride) Versus DETROL LA (Tolterodine Tartrate) in Treatment of Overactive Bladder NCT00293839	Phase 3	Completed	Alza Corporation, DE, USA	790	— → 2002-12
Fasting Study of Oxybutynin Chloride ER Tablets 10 mg and Ditropan XL® Tablets 10 mg NCT00649129	Phase 1	Completed	Mylan Pharmaceuticals Inc	36	2002-07 → 2002-08
Inflammation in Women With Urgency Urinary Incontinence Treated With Anticholinergics NCT04090190	Phase 4	Completed	Brigham and Women's Hospital	20	2019-10-30 → 2021-10-31
Fesoterodine and Oxybutynin XL for Overactive Bladder Syndrome in Children NCT02327936	Phase 3	Completed	Stéphane Bolduc	62	2014-12 → 2018-08

Source: ClinicalTrials.gov. Trials matched by ingredient name.

Drug Pricing (NADAC)

National Average Drug Acquisition Cost — Week of 2026-07-15 | 1 NDC

Highest NADAC/Unit

$81.52

per ea

Lowest NADAC/Unit

$81.52

per ea

Brand NDCs

Generic NDCs

NDC Description	NADAC/Unit	Unit	Type	Generic NADAC	Effective
00023615308OXYTROL 3.9 MG/24HR PATCH	$81.52	EA	Brand	—	2026-06-17

Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.

VA Federal Supply Schedule

Government-negotiated contract prices | 2 NDCs (1 FSS, 1 Big4)

Lowest Price

$307.47

Highest Price

$307.47

FSS NDCs

Big4 NDCs

Description	Price	Type	Vendor	Contract End
00023-6153-08OXYTROL 3.9MG/24HRS TRANSDERMAL SYSTEM	$307.47	FSS	Abbvie US LLC	07/31/2030
00023-6153-08OXYTROL 3.9MG/24HRS TRANSDERMAL SYSTEM	$307.47	Big4	Abbvie US LLC	07/31/2030

Source: VA Federal Supply Schedule (va.gov). Prices are government-negotiated contract prices.

Medicare Part D Spending

CMS annual spending data for Oxytrol (2024)

Total Spending

$1.4M

Total Claims

1,434

Beneficiaries

425

Avg Cost/Unit

$82.99

Spending Trend

$3.8M(2019)→$2.9M(2020)→$2.6M(2021)→$2.2M(2022)→$1.8M(2023)→$1.4M(2024)

YoY Change:-3.3%

5yr CAGR:+0.2%

Source: CMS Medicare Part D Spending by Drug (2024). Shows gross drug cost under Part D.

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

9 letters from Drugs@FDA

Date	Submission	Document
May 30, 2024	SUPPL -20	View Letter (PDF)
Oct 30, 2017	SUPPL -18	View Letter (PDF)
Oct 30, 2017	SUPPL -17	View Letter (PDF)
Jul 13, 2015	SUPPL -16	View Letter (PDF)
Oct 12, 2012	SUPPL -8	View Letter (PDF)
Oct 12, 2012	SUPPL -9	View Letter (PDF)
Feb 3, 2011	SUPPL -5	View Letter (PDF)
Jul 13, 2006	SUPPL -2	View Letter (PDF)
Mar 10, 2003	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#002 — 3.9MG/24HR

RLD

0 patents0 exclusivities▴

FILM, EXTENDED RELEASE;TRANSDERMAL | Approved: Feb 26, 2003

No patent or exclusivity listings for this strength.