DITROPAN XL
LOE ApproachingNDAORALTABLET, EXTENDED RELEASE
Approved
Dec 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
6
Data completeness
5/8 — Partial
DITROPAN XL by Johnson & Johnson is clinical pharmacology oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Approved for overactive bladder with symptoms of urge urinary incontinence, urgency, frequency and 2 more indications. First approved in 1998.
Drug data last refreshed 15h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DITROPAN XL is an extended-release oral formulation of oxybutynin chloride, an anticholinergic agent that relaxes bladder smooth muscle by inhibiting muscarinic acetylcholine action. It treats overactive bladder with symptoms of urge incontinence, urgency, and frequency in adults and pediatric patients aged 6+ with neurological detrusor overactivity. The extended-release formulation maintains steady plasma concentrations over 24 hours, improving tolerability versus immediate-release formulations.
$0.042BPart D
LOE ApproachingProduct nearing loss of exclusivity with modest Medicare spending; commercial teams should prepare for market contraction and generic competition.
Mechanism of Action
CLINICAL PHARMACOLOGY Oxybutynin chloride exerts a direct antispasmodic effect on smooth muscle and inhibits the muscarinic action of acetylcholine on smooth muscle. Oxybutynin chloride exhibits only one-fifth of the anticholinergic activity of atropine on the rabbit detrusor muscle, but four to…
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.