Oxybutynin Chloride

Sold as Ditropan, Ditropan Xl, Gelnique. Every FDA application for this active ingredient: 4 branded and 35 generic.

As of Nov 15, 2026, FDA lists 39 applications for Oxybutynin Chloride (sold as Ditropan, Ditropan Xl, Gelnique), first approved Jul 16, 1975, with 5 new uses approved and 0 published complete response letters.

First approved: Jul 16, 1975
Applications: 39
New uses approved: 5
Complete response letters: 0
Medicare spending, 2025: $122M
First approved in the EU: Jun 15, 2004

Medicare Spending

CMS Part D and Part B, 2025, before manufacturer rebates; matched by generic name


Oxybutynin Chloride ER	Part D	$90.2M	+18%	900,887
Oxybutynin Chloride	Part D	$31.7M	-8%	566,657
Gelnique	Part D	$0K	-100%	0

What Pharmacies Pay

Median price per unit across package codes in CMS's weekly NADAC survey, Nov 11, 2026, before rebates; see every drug's price change

OXYBUTYNIN 2.5 MG TABLET: $1.82 per unitGeneric · -15% in a year
OXYBUTYNIN 5 MG TABLET: $0.049 per unitGeneric · +1% in a year
OXYBUTYNIN 5 MG/5 ML SOLUTION: $0.033 per MLGeneric · +3% in a year
OXYBUTYNIN 5 MG/5 ML SYRUP: $0.033 per MLGeneric · +3% in a year

Approvals in the EU (EMA)

First approved in the EU 347 months after the US. Centrally authorised medicines, matched by ingredient; see all EU approvals

Kentera (previously Oxybutynin Nicobrand), new substanceTeva B.V. · Jun 15, 2004

Approvals in Japan (PMDA)

PMDA's English list since 2008, matched by ingredient; see all Japanese approvals

Apohide, new approvalA drug with a new indication in a new dosage form for the treatment of primary palmar hyperhidrosis. · Hisamitsu Pharmaceutical Co., Inc. · Mar 27, 2023
Neoxy, new approvalA drug with a new route of administration and new indications for the treatment of urinary urgency, urinary frequency, and urge urinary incontinence… · Hisamitsu Pharmaceutical Co., Inc. · Mar 25, 2013

Clinical Trials

22 open or ongoing studies name this ingredient as an intervention, including as a comparator; newest first. See all


Effect of Oxybutynin on Opioid Use After Urologic Surgery in ChildrenUreteropelvic Junction Obstruction, Hypospadias · University of Calgary	Phase 4	Not yet recruiting	Nov 2, 2026
Parasacral TENS ProjectOveractive Bladder (OAB), Lower Urinary Tract Dysfunction · University of Virginia	Not applicable	Not yet recruiting	Oct 23, 2026
Hormone thERapy Effects on BRAin-HEART Health During the Menopausal TransitionMenopause, Perimenopause · McGill University Health Centre/Research Institute of the McGill University Health Centre	Phase 4	Not yet recruiting	Jul 29, 2026
A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in AdultsObstructive Sleep Apnea (OSA) · Sairam Parthasarathy	Phase 4	Recruiting	Jul 1, 2026
Combination Upper-Airway Electrical and Pharmacological Stimulation for Obstructive Sleep ApneaObstructive Sleep Apnea, Sleep-disordered Breathing · Brigham and Women's Hospital	Phase 1 / Phase 2	Recruiting	May 11, 2026
Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.Overactive Bladder (OAB) · Trigone Pharma Ltd.	Phase 2	Not yet recruiting	Feb 6, 2026
Endotype DIrected Treatment for OSA in Down SyndromeObstructive Sleep Apnea (OSA), Down Syndrome · University of Arizona	Phase 4	Recruiting	Dec 12, 2025
Behavioral Interventions Versus Pelvic Floor Muscle Therapy as Adjuncts to Anticholinergic Pharmacotherapy for Urgency Urinary Incontinence: A Non-Inferiority TrialUrgency Urinary Incontinence · Emilio José Dávila Álvarez	Not applicable	Active, not recruiting	Dec 2, 2025

Applications

NDAs, BLAs and generic ANDAs for this ingredient, oldest first; each opens its full history


Jul 16, 1975	DitropanNDA 17577 · New molecular entity	Janssen Pharms	33	Discontinued
Nov 29, 1979	DitropanNDA 18211 · New dosage form	Ortho Mcneil Janssen	16	Discontinued
Nov 14, 1988	Oxybutynin ChlorideANDA 71655	Teva Pharms USA	16	Marketed
Mar 29, 1996	Oxybutynin ChlorideANDA 74520	Lannett Co Inc	5	Marketed
Jul 31, 1996	Oxybutynin ChlorideANDA 74625	Aiping Pharm Inc	9	Marketed
Feb 12, 1997	Oxybutynin ChlorideANDA 74868	Pharmobedient Cnsltg	0	Discontinued
Oct 15, 1997	Oxybutynin ChlorideANDA 74997	Pharm Assoc	2	Discontinued
Oct 31, 1997	Oxybutynin ChlorideANDA 75079	Strides Pharma Intl	8	Marketed
Dec 16, 1998	Ditropan XlNDA 20897 · New dosage form	Janssen Pharms	23	Discontinued
Dec 18, 1998	Oxybutynin ChlorideANDA 75137	Pharm Assoc	0	Discontinued
Jan 29, 1999	Oxybutynin ChlorideANDA 75039	Chartwell Rx	2	Marketed
Dec 28, 2004	Oxybutynin ChlorideANDA 76682	Lannett Co Inc	2	Discontinued
Nov 9, 2006	Oxybutynin ChlorideANDA 76702	Pharmobedient	8	Discontinued
Nov 9, 2006	Oxybutynin ChlorideANDA 76644	Pharmobedient	6	Discontinued
Nov 9, 2006	Oxybutynin ChlorideANDA 76745	Impax Pharms	7	Discontinued
May 10, 2007	Oxybutynin ChlorideANDA 78293	Mylan Pharms Inc	0	Marketed
Jan 27, 2009	GelniqueNDA 22204 · New dosage form	Abbvie	6	Discontinued
Feb 4, 2009	Oxybutynin ChlorideANDA 78503	Osmotica Pharm US	7	Marketed
Nov 23, 2015	Oxybutynin ChlorideANDA 204010	Amneal Pharms	4	Marketed
Feb 29, 2016	Oxybutynin ChlorideANDA 207138	Accord Hlthcare	4	Marketed
May 27, 2016	Oxybutynin ChlorideANDA 206121	Unique	4	Marketed
Jun 26, 2017	Oxybutynin ChlorideANDA 202332	Zydus Pharms	3	Marketed
Oct 23, 2017	Oxybutynin ChlorideANDA 209823	Novitium Pharma	0	Marketed
Dec 21, 2017	Oxybutynin ChlorideANDA 209025	Rising	0	Marketed
Dec 22, 2017	Oxybutynin ChlorideANDA 209335	Abhai LLC	0	Marketed
May 31, 2018	Oxybutynin ChlorideANDA 207329	Chartwell Rx	0	Discontinued
Sep 6, 2018	Oxybutynin ChlorideANDA 210125	Tp Anda Holdings	0	Marketed
Feb 6, 2019	Oxybutynin ChlorideANDA 211062	Adaptis	0	Discontinued
Feb 28, 2019	Oxybutynin ChlorideANDA 211655	Ajanta Pharma Ltd	2	Marketed
May 10, 2019	Oxybutynin ChlorideANDA 211682	Heritage Pharma Avet	1	Marketed
Oct 30, 2019	Oxybutynin ChlorideANDA 210611	Novast Labs	0	Marketed
Dec 17, 2019	Oxybutynin ChlorideANDA 210717	Bionpharma	1	Marketed
Apr 6, 2020	Oxybutynin ChlorideANDA 212798	Leading	0	Marketed
Oct 27, 2020	Oxybutynin ChlorideANDA 214415	Rubicon Research	1	Marketed
Dec 17, 2020	Oxybutynin ChlorideANDA 208165	Strides Pharma	0	Marketed
Jul 14, 2022	Oxybutynin ChlorideANDA 213550	Regcon Holdings	0	Marketed
—	Oxybutynin ChlorideANDA 70746	Usl Pharma	0	Discontinued
—	Oxybutynin ChlorideANDA 72296	Quantum Pharmics	0	Discontinued
—	Oxybutynin ChlorideANDA 72485	Watson Labs	0	Discontinued

Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA