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DITROPAN

NDA

OXYBUTYNIN CHLORIDE | N017577 | JANSSEN PHARMACEUTICALS INC

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

1 petition (1 open) from Regulations.gov

Petition	Type	Filed	Status	Petitioner
Amendment to Suitability Petition for Oxybutynin Chloride Tablets, USP 2.5 mg FDA-2016-P-1088 ABHAI, LLC filed an amendment to a suitability petition under 21 CFR 314.93 requesting FDA approval to submit an ANDA for Oxybutynin Chloride Tablets in a 2.5 mg strength, an additional strength to the approved 5 mg strength referenced to Janssen Pharmaceuticals' NDA 017577. The petitioner argues cl	Suitability	2020-10-05	Open	—

Source: Regulations.gov. FDA citizen petitions matched by application number.

Clinical Trials

3 trials from ClinicalTrials.gov — 1 recruiting, 2 completed

Trial	Phase	Status	Sponsor	Enrollment	Dates
A Comparative Effectiveness Study of Positive Airway Pressure (PAP) Therapy, Dental Device, and Atomoxetine-Oxybutynin for Treatment of Obstructive Sleep Apnea in Adults NCT07679282	Phase 4	Not Yet Recruiting	Sairam Parthasarathy	2,400	2026-09-01 → 2032-05-01
A Novel Pharmacological Therapy for Obstructive Sleep Apnea NCT03919955	Phase 2	Completed	Brigham and Women's Hospital	117	2019-09-03 → 2023-09-07
Efficacy and Safety of Mirabegron Versus Oxybutynin After Posterior Urethral Valve Ablation NCT07668232	N/A	Completed	South Valley University	52	2025-01-01 → 2025-12-30

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

Medicare Part D Spending

CMS annual spending data for Oxybutynin Chloride ER (2023)

Total Spending

$113.1M

Total Claims

3,360,126

Beneficiaries

881,680

Avg Cost/Unit

$0.55

Spending Trend

$151.7M(2019)→$153.5M(2020)→$146.9M(2021)→$137.6M(2022)→$113.1M(2023)

YoY Change:-22.3%

5yr CAGR:-12.4%

Source: CMS Medicare Part D Spending by Drug (2023). Shows gross drug cost under Part D.

API Supply Chain6 active DMFs4 inactive

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

PCASOXYBUTYNIN CHLORIDE USP

DMF 64121986

APITORIA PHARMA PRIVATE LTDOXYBUTYNIN CHLORIDE

DMF 194472006

HARMAN FINOCHEM LTDOXYBUTYNIN CHLORIDE

DMF 228522009

RESONANCE LABORATORIES PVT LTDOXYBUTYNIN CHLORIDE (OBTN)

DMF 237572010

TAPI NL BVOXYBUTYNIN CHLORIDE USP

DMF 265372012

THINQ PHARMA-CRO LTDOXYBUTYNIN CHLORIDE USP

DMF 343362020

ZEELAND CHEMICALS INCInactiveOXYBUTYNIN CHLORIDE

DMF 62721986

ABBOTT LABORATORIES PHARMACEUTICAL PRODUCTS DIVInactiveOXYBUTYNIN CHLORIDE

DMF 63691986

SANOFI AVENTIS SPAInactiveOXYBUTYNIN CHLORIDE

DMF 128401998

WOCKHARDT BIO AGInactiveOXYBUTYNIN CHLORIDE USP

DMF 160612002

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

Approval Letters

6 letters from Drugs@FDA

Date	Submission	Document
Mar 26, 2012	SUPPL -38	View Letter (PDF)
Dec 20, 2011	SUPPL -37	View Letter (PDF)
Aug 10, 2011	SUPPL -36	View Letter (PDF)
Jul 16, 2009	SUPPL -35	View Letter (PDF)
Feb 13, 2008	SUPPL -34	View Letter (PDF)
May 29, 2003	SUPPL -33	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — 5MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**

RLD

0 patents0 exclusivities▴

TABLET;ORAL | Approved: Approved Prior to Jan 1, 1982

No patent or exclusivity listings for this strength.