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 20h ago · AI intelligence enriched 2w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ENABLEX (darifenacin hydrobromide) is an oral extended-release antimuscarinic tablet approved for overactive bladder with symptoms of urge urinary incontinence, urgency, and frequency. It works by selectively antagonizing M3 muscarinic receptors on bladder smooth muscle, increasing bladder capacity and reducing involuntary contractions.
LOE Approaching
Product is approaching loss of exclusivity with moderate competitive pressure (30%), suggesting the brand team is transitioning to LOE defense strategies and likely operating at reduced headcount.
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.