NDAORALTABLET, EXTENDED RELEASE
Approved
Dec 2004
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
1
Data completeness
4/8 — Partial
ENABLEX (darifenacin hydrobromide) by AbbVie is clinical pharmacology figure 1 mean (sd) steady state darifenacin plasma concentration time profiles for enablex® 7. Approved for overactive bladder with symptoms of urge urinary incontinence, urgency, frequency. First approved in 2004.
Drug data last refreshed 3h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENABLEX (darifenacin hydrobromide) is an oral extended-release tablet that selectively antagonizes M3 muscarinic receptors to treat overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. It works by inhibiting involuntary detrusor contractions, increasing bladder capacity and reducing the frequency of unstable contractions.
LOE Approaching
Product approaching loss of exclusivity with declining market opportunity; brand teams face transition to generic-era defense strategies and managed care focus.
Mechanism of Action
CLINICAL PHARMACOLOGY Figure 1 Mean (SD) Steady State Darifenacin Plasma Concentration Time Profiles for ENABLEX® 7.5 and 15 mg in Healthy Volunteers Including Both CYP2D6 EMs and PMs* General Darifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role…
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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.