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 Yesterday · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENABLEX (darifenacin hydrobromide) is an oral extended-release antimuscarinic agent that selectively targets M3 muscarinic receptors with 9-12 fold greater affinity than M1/M5 receptors. It treats overactive bladder (OAB) by increasing bladder capacity and reducing involuntary detrusor contractions, urgency, and urge incontinence. The drug demonstrates selectivity for bladder M3 receptors, potentially offering a favorable side effect profile compared to non-selective antimuscarinics.
LOE Approaching
Product approaching loss of exclusivity with moderate competitive pressure (30% rating); brand team likely focused on lifecycle management and generic transition planning rather than growth expansion.
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.